CITI TRAINING

The patient authorization and consent form: (Select all that apply)

- Are voluntary agreements made by the subject. - Either document can be waived by the IRB under certain circumstances.

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Occur at least annually.

Which of the following most accurately describes good mentoring practice?

Encouraging trainees to receive mentoring from a collection of individuals.

The ICH GCP guidelines:

Set standards for the design, conduct, monitoring and reporting of clinical research.

Which of the following is included in the Nuremberg Code:

Voluntary consent

Attachments sent with emails, and links within emails, are:

Should be regarded with caution, because attachments can contain malware, and links can point one to a dangerous website with the same threat.

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

When radiation is absorbed in tissue the ionization and excitation energy result in which of the following:

- formation of free radicals - breakage of chemical bonds - damage to regulators, proteins, DNA, RNA - new bonds and cross links in macro molecules

Which of the following are less sensitive to radiation?

- nerve cells - muscle cells

When a subject signs a consent document, a note in the research record should include:

All of the above

To minimize potential risks of harm, a researcher conducting an on-line survey can:

Design the survey so that no direct or indirect identifiers are collected.

Patients have to provide an additional, specific authorization for training uses and disclosures of their information.

False

Who has ultimate responsibility for an investigational product?

Investigator

Which of the following is not correct with respect to using BCC for recipients of a message?

It should be the default for all correspondence.

When patients receive a copy of an organization's privacy notice, why are they asked to sign an acknowledgment?

It shows they received it.

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

Obtain a waiver of documentation of informed consent.

Census data (the final report as published by the Census Bureau) is an example of:

Public information

Access passwords (or PINs) and device encryption for devices are:

Recommended for all devices, but particularly for portable ones because they may be more easily lost or stolen.

The specific Department of Health and Human Services (HHS) regulations that apply to research with children are known as:

Subpart D: Additional Protections for Children Involved as Subjects in Research

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

The changes must be immediately implemented for the health and well-being of the subject.

Shielding compounds with Beta particle emission is extremely important when their energy is above a few 100 kev because:

they can penetrate deeper in tissue they have a longer range they produce secondary radiations

Some types of radiation can penetrate the body and cause biological harm.

true

An area wipe test of 100 cm2 that exceeds _____ dpm should be decontaminated, re-wiped, and results recorded.

200

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

Which of the following statements is true regarding authorship practices?

Different disciplines have different practices about who should be included as an author.

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

Disclose their potential COI and may answer questions, but recuse themselves from voting

A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Which example of research with prisoners would be allowable under the regulations?

Examining age at first arrest as a predictor of adult criminal history.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent.

Even though VHA requires that investigational drugs be stored and dispensed by Pharmacy Service, FDA requires that the Investigator bear primary responsibility for all aspects of investigational drug accountability.

True

For VHA trials involving investigational drugs, it is mandatory that all drugs must be carefully controlled and that drug accountability is maintained.

True

A medical record is an example of:

Private information

Development of most new drugs, from discovery to marketing approval, usually takes:

9 years or more

The term dual use is normally defined as an item or technology that:

Has both civilian and military uses

A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:

Confidentiality of the prisoners' health status is maintained.

Which of the following is an important component of drug accountability?

Drug shipping and disposition records

The overall goal of monitoring, audits, and inspection activities is to:

Ensure the protection of human research subjects and data integrity.

Under HIPAA, a "disclosure accounting" is required:

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

Who is the Radiation Safety Officer at the Atlanta VAMC?

Mr. Roland Phillips

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Plagiarism

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study (2006-2009)

The Sunshine Act requires manufacturers to report "payments of transfers of value" for how much annually?

$10.00

Information sharing requires considering both the type of information and the context of sharing. Which of the following statements about information sharing is correct?

All of the above

Which of the following should be part of the FDA inspection process?

All of the above

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge.

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?

Directory information.

Email and messaging are generally best suited for situations when:

Exchanging basic information (such as in preparation for a meeting) provided the material is not so technical that it will still be unclear from an email exchange.

Which of the following is true regarding research misconduct?

Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.

The main focus of NIH's conflict of interest policy is:

Financial conflicts of interest

Secure communications, like that provided by "encrypted" web connections using https or a Virtual Private Network (VPN), are:

Generally considered essential for smartphones and tablets, because time sensitive information is being accessed, received, or transmitted.

Secure communications, like those provided by "encrypted" web connections using https or a virtual private network (VPN), are:

Generally considered essential.

HIPAA privacy protections cover identifiable personal information about the "past, present or future physical or mental health condition." What does that include?

Health information in any form or medium, as long as it is identified (or identifiable) as a particular person's information.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations.

Select all of the following that are considered Essential Documents for the Investigator File: (Select all that apply)

- Protocol. - Copies of correspondence with the IRB. - Investigator Brochure. - Investigator's Curriculum vitae. - Training records of the study clinic personnel.

ICH E6 describes standards that apply to:

Investigators, sponsors, and IRBs

Accurate reporting of adverse events is most important for:

Ensuring subject safety.

The National Security Decision Directive (NSDD) 189 defines:

Fundamental Research

A radioactive package wipe that exceeds ______ dpm should be reported to the Radiation Safety Office.

200

Which of these is a greater risk "off site" than when a computer is used in a protected office environment?

ALL OF THE ABOVE "Environmental" threats - such as water, electrical or fire damage. Human threats - such as theft. Device malfunctions - such as a hard drive crash.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

Asking women if they have had an abortion

Which of the following is the least important activity when protecting human subjects in international research?

Assessing transportation conditions

The intended functions of GCP are to (Select all that apply)

Assure that the data and reported results are accurate and credible. Protect the rights, well-being, and confidentiality of trial subjects.

Which of the following is a good practice if one wishes to avoid "social engineering" attacks?

Being cautious any time someone asks for sensitive information, whether by phone, fax, email, or even in person. It could be a phishing scam. Using strict procedures when it is necessary to exchange an authentication credential like a password, PIN, account number, or other personal data that is critical to establishing personal identity. Not opening attachments or clicking on links in messages, emails, or on websites unless absolutely sure of the source's authenticity. Taking appropriate steps to confirm a person's (or site's) identity for any transaction that involves sensitive data.

Which of the following is not a correct statement about email?

Employees and students have strong privacy protections with respect to their emails, so they cannot be inspected by employers or educational authorities without a search warrant.

Enabling encryption of all data on a desktop or laptop computer is generally considered:

Essential for any computer. Only data on computers that are guaranteed to contain no sensitive information, or where the physical and technical security of the device is assured, can safely be left unencrypted.

Which of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal

Freeware and shareware sites are:

Higher risk. So, use caution and be aware of organizational policies that may prohibit them at work.

Which best describes the role of the clinician in managing privacy matters?

How clinicians handle information inevitably sets the tone for everyone else, so the example they set is critical.

Where is information on storage requirements for the investigational product usually found?

In the study protocol

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

Which of the following most accurately describes the risks associated with SBR?

Less predictable, more variable, and less treatable than physical harms

Which of the following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest.

Devices used purely for storage, like USB flash ("thumb") drives and external hard drives:

May expose large amounts of data if compromised, so should also use protections like access passwords or PINs, and whole-device data encryption.

If research in a private school is directly funded by the Department of Education, then:

PPRA applies.

PPRA gives parents some level of control over their child's:

Participation in third-party survey research or exposure to instructional materials developed by researchers

At which study visits can the site expect the sponsor to review subjects' signed informed consent forms?

Periodic and termination site visits

Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?

Periodic site visits

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

OHRP is an oversight body primarily concerned with:

Protection of human research subjects

When the FDA conducts an inspection, the inspectors will:

Review regulatory records.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

The IRB will not review this study because it is not research as defined by the federal regulations.

Which of the following is the agency that authorizes export licenses:

The US Department of State

You cannot pour radioactive liquids down any laboratory drains.

true

A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?

Breach of confidentiality from the focus group subjects (therapists)

Which of the following is true regarding the reporting of research results?

Clear specification of the methods and procedures used is essential.

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?

Confidentiality of the individual subject's responses

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

No later than the time of proposal submission

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?

Physical control, coercion, undue influence, and manipulation

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

A conflict of interest committee

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Designing the survey so that subjects are not forced to answer one question before going to the next.

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Experience emotional or psychological distress.

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (There may be more than one correct answer. Please be sure to select all correct answers.)

Faculty advisor and IRB office

Third-party add-on software can defeat all of a device's security measures if it contains malware. Which of the following statements is correct about third-party add-on software?

For a work device, particularly if it is provided by an employer, individuals should install only what has been expressly approved.

Secure disposal of a portable device at the end of its service life is:

Generally considered essential for all devices. One should not assume there is no sensitive personal or organizational data on a device or accessible by it.

Broadly speaking, the compromise of personal information falls under the heading of identity theft. Which of the following is a correct statement about identity theft?

Identity theft can occur because of a compromised computer account, but also from information one posts publicly, like on an unprotected page of a social networking site.

Software on a desktop or laptop computer should be:

Installed or updated only from trusted sources to be certain that it is a legitimate version.

Information can be catastrophically compromised by installation of malicious software (malware) on a computing device. Which of the following is a correct statement about malware?

Once installed, malware can harvest personal information (such as from an address book to propagate itself to a person's contacts).

Which category of health information does HIPAA extend "extra" protections, with a requirement for separate authorization?

Psychotherapy notes

An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?

Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?

Site initiation visit

Which of the following is generally allowed in most organizations?

Social networking if done for approved business-related purposes.

How are the ethical standards for student uses and disclosures of patients' health information different from those for regular members of the healthcare workforce?

Some would say it is higher, because patients do not always benefit from students' access to their data.

The decay constant and _____________ are measures of how fast a radionuclide decays and are inversely related.

half-life

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?

the author can contact the editor with their concerns.

What "technical measures" do you usually need to take with an off-site computer?

ALL OF THE ABOVE Keep the operating system and applications software updated. Use a firewall or other intrusion detection/prevention system. Install anti-virus and anti-spyware software. Use passwords and other authentication mechanisms to protect against unauthorized access.

Which of the following is a correct statement about browser "save-the-password" tools and add-on password management tools?

Allowing a browser to save the password, or using a password management tool to record passwords, can be a safe alternative but only if used appropriately.

An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following?

An investigator's agreement An investigator's agreement is signed by an investigator conducting a study of a medical device under an IDE. There is no standard FDA form for investigator agreements. The other choices are not specified in investigational device regulations

According to ICH E6, an inspection is defined as:

An official review of documents, facilities, records, and any other resources related to a clinical trial.

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

How can faculty researchers avoid undue influence of student subjects?

Avoid using their own students in their research

The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage Analysis (MCA) are used interchangeably. At Emory, the purpose of the PRA is to assist with research billing compliance, which is

Billing the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects involved in a research study.

Recruiting into research ...

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

Investigational product dispensing or administration information for the sponsor is recorded on the:

Case report form

Adjudication of research participant's bills allows which department to direct charges to the correct payer?

Clinical Trials Billing Department (CTBD)

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance.

Which of the following is true regarding data analysis?

Data analysis methods should usually be specified in advance before a study begins.

Data are made anonymous by

Destroying all identifiers connected to the data.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.

Which of the following is not a correct statement about the security risks of email attachments and links embedded within emails?

Email attachments and web links that are received in messages should be confirmed as safe. Recipients should be wary, even if the sender is known and considered safe.

Which system provides the status of a clinical trial agreement (CTA)?

Emory Contracts Tracking System (eCTS)

Enabling a device login password or PIN, and an inactivity timeout to force (re)login with that password or PIN after the device is idle for a defined period, is generally considered:

Essential for any computer.

The National Research Act of 1974

Established the National Commission.

A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?

Exempt Review

Which of the following sources describe the principles of Good Clinical Practice (GCP)? (select the best answer)

FDA guidelines. ICH guidelines. FDA regulations.

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability?

High potential for individual benefit from participating in research

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:

How the data will be collected and secured. If the study results, if any, will be included in the employee's personnel records. Who will have access to the data. If personal identifiers will be retained and used in the data analysis.

A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

In terms of explaining the probability of assignment to trial arms in consent forms, which is true?

ICH notes that it should be included, but does not specify how the information should be presented.

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?

IND report

Unless the subject matter is considered common knowledge, citations are necessary when writing about:

Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data.

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Identifiable health information that is created or held by covered entities and their business associates.

Which of these is not a good practice with respect to responding to emails?

If a message offers an opt-out link option, always respond to it to be removed from that mailing list.

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research.

An idea is most likely to represent "common knowledge" if:

It can be safely assumed that the readers and the author are both thoroughly familiar with the idea and its source.

What is the status of ICH in U.S.?

It is a FDA guidance.

Which of the following most accurately describes the practice of ghost authorship?

It is a situation where the individual who wrote the manuscript is not listed as an author.

Which of these is correct about physical security?

It is as important as ever, because controlling physical access to electronic and non-electronic (paper) systems is always critical.

Which of the following most accurately describes the function of the Office of Foreign Assets Control (OFAC):

It regulates economic and trade sanctions based on foreign policy and national security goals

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

Which of these is not a good practice for controlling computer access?

Logging into systems with a shared user-ID or password.

If the FDA schedules an appointment to inspect your studies, which department at Emory should you contact first in preparation for the FDA visit?

Office of Compliance

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

Preclinical

For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?

Preclinical data

Reviewers have a responsibility to promote ethical peer review by:

Preserving the confidentiality of the submission.

Which monitoring visit would not include an inventory of investigational agents?

Prestudy site visit

Proper management of investigational products promotes subject and public safety by:

Preventing diversion and use by non-study participants. Indicating possible under-dosing or overdosing by study patients (non-compliance). Facilitating proper disposal of potentially harmful substances.

A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event?

Principal Investigator

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Prisoners may be used to conduct research that only benefits the larger society

Which of these is correct about identity theft?

Protection of workplace identity requires protecting the things that establish identity -- what one knows, what one possesses, and what one "is" (biometrically).

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

The VA Pharmacy Service is responsible for which of the following activities in trials involving investigational drugs?

Receipt, storage, and dispensing of the drugs.

In the context of a computer system, what does an "audit trail" do?

Record activity on a computer system.

A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should the investigator do when learning of the crash?

Report adverse events of both a broken wrist and a mild concussion.

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. "Increased WBC count" is not listed in the Investigator's Brochure (IB) as an adverse event. The investigator should:

Report the elevated WBC to the sponsor as an unexpected adverse event

Getting your proposal prepared for review and approval can be cumbersome. Which department in the Office of Research Administration assists with proposal preparation?

Research Administration Services (RAS)

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

Respect for persons

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

Which of these is not generally a good practice for fax machine use?

Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine.

Which of the following is an investigator's commitment to the sponsor?

Submit a new Form FDA 1572 to the sponsor as needed

An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?

Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Which of the following is true regarding an acknowledgments section?

The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.

Which author is normally responsible for sharing reprints of a publication with readers?

The corresponding author.

Which of the following is a correct statement about the balance among prevention, detection, and response (PDR)?

The greater the sensitivity and quantity of the data at issue, the more carefully the balance among these three must be evaluated.

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:

The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.

When choosing the security measures needed for a desktop or laptop computer:

The more security measures applied, the more secure a computer will be. However, it is impossible to have a uniform set of rules for all circumstances.

When evaluating the causality of an adverse event, which of the following should be a consideration?

The timing of the event in relation to administration of the investigational agent

Data ownership is typically determined by:

The type and source of funds used to support the project.

According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism?

There is no official, federal standard for the number of consecutive words that can be used.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

Under the Privacy Rule, the people and groups that can view a patient's medical record include:

Those individuals and groups allowed access by the wording in the informed consent/authorization form.

An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?

Treat the patient with the drug based on physician's best medical judgment

It is safe to obtain web addresses from:

Trusted search engines or trusted documents.

The best time to prepare for an FDA inspection is:

When you are initiating your study

The most important factor determining whether a research collaboration will be successful is:

Whether there is ongoing communication about goals and responsibilities.

Which of the following is correct about email transmission and storage?

While defensive technologies exist, it is still best to think of email as an electronic postcard, subject to potential access by third parties while in route or at its destination.

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

must be more detailed for disclosures that involve fewer than 50 subject records.

Under the Code of Federal Regulations Part 20, Standards for Protection Against Radiation, the security of radioactive materials includes:

radioactive material security verification logs

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.

true

Which statement best describes what an IRB is responsible for reviewing?

Research involving a human subject

All volatile radioactive material should be used in an operational and certified fume hood.

true

Which of the following most accurately describes voluntary committed cost sharing?

It means that the cost share is quantified in the proposal but not required by the sponsor.

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial or non-financial interests could interfere with its research activities.

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer.

Which of the following most accurately describes allocability?

It refers to how direct expenses are calculated based on the benefit to the project.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

Which of the following is most likely to create a poor relationship between a mentor and a trainee?

A mentor who recruits trainees merely for the mentor's own career advancement.

Which best matches the NIH definition of a clinical trial?

A research study in which one or more humans subjects are assigned to evaluate the effects of those interventions involving health-related biomedical and behavioral outcomes.

An example of an individual financial COI is:

A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

For a minimum of three years after completion of the study

What kinds of persons and organizations are affected by HIPAA's requirements?

Healthcare providers, health plans, and health information clearinghouses, as well as their business associates and by extension the workers for those organizations.

Which is true of inducements in research?

Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...

Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

Which of the following most accurately describes an 2 CFR Part 200.425(2) audit?

It is an annual audit of an organization that receives over a certain threshold of federal funds each year.

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?

Significant risk device

Crystal clear theory refers to the notion that:

The financial details of a project should be explained plainly enough so that a non-expert would be able to understand them.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?

The researcher will not be interacting/intervening with subjects and the data has no identifiers.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

The HIPAA "minimum necessary" standard applies...

To all human subjects research that uses PHI without an authorization from the data subject.

What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?

To determine compliance with regulatory requirements, including those relating to protecting research subjects.

Failure to adhere to the protocol and the signed investigator statement/agreement is one of the most common inspection and audit findings.

True

The protocol, as approved by the IRB, must be followed even in those cases in which the specified activity would not be performed in a treatment situation except when it is necessary to eliminate an immediate hazard to human subjects.

True

To facilitate Pre-award submissions and their approval, the study team should submit to the Institutional Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT.

True

HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary standard. What is excused?

Truly accidental "excess" uses and disclosures, where reasonable caution was otherwise used and there was no negligence.

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to research, marketing, and fundraising go?

Uses or disclosures that generally require specific written authorization.

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.

As part of a research study, a physician plans to review medical records to explore factors related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?

The study is human subject research which is eligible for expedited review.

Closeout instructions on a sponsored project are most directly determined by:

The terms and conditions in the agreement with the sponsor.

Which of the following most accurately describes the main purpose of the OMB Circulars?

They outline the rules for the financial management of sponsored projects.

The exposure limit for the unborn child during the gestation period is ____% of the maximum permitted annual dose for radiation workers.

10%

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

Which statement best describes the role of an IRB:

A committee that reviews different types of human subjects research

Which statement best describes information that must be included in a consent form?

A description of the research's potential benefits and risks

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

Which of following protocols is the one that is most likely to require IRB review?

A study to evaluate a newly designed wheelchair by asking elderly individuals to use it.

What "physical" security measures do you usually need to take for an off-site computer?

All of the above Keep the computer locked up - or in a locked room - to prevent physical access by others. Pay attention to the environmental safety of the computer's location - to prevent damage by water, etc. Keep secure backup copies in a separate, physically secure location.

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:

Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?

An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in Research Report" for each project in eCOI?

Annually

What are the main elements necessary for ensuring that costs are appropriately charged?

Applying allocable, allowable, consistent, and reasonable costing policies and procedures.

The packaging of investigational drugs should ideally:

Be designed to help with subject compliance

When conducting an industry-sponsored trial at a VHA facility, the researcher must comply with the adverse event reporting requirements of all of the following except the:

Belmont Report. Researchers must comply with the requirements of both the sponsor and IRB, providing exactly what each has specified. The Belmont Report addresses ethical principles, not adverse event reporting.

Information security's goals are sometimes described by the letters "CIA." Which of the following is correct definition of C, I, or A?

Confidentiality, Integrity, and Availability (CIA) In order to fulfill privacy requirements, security measures first and foremost aim to assure confidentiality. That is, that sensitive information is accessed only by appropriate persons for appropriate reasons. It is also important to take steps to assure the integrity (accuracy) and availability of data for its legitimate users. Integrity is the security equivalent of terms like data validity and reliability. If data are lost or corrupted, so no longer valid or reliable for their intended uses, or are not available when needed for those uses, an information system is effectively useless.

What is the term for when a sponsor requests that the organization contribute financial support to a project?

Cost Sharing

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

Data that does not cross state lines when disclosed by the covered entity.

When must the investigator update the IRB about the progress of a trial?

During the conduct of the study and at termination

Exposure to levels at or below those established for occupational radiation workers significantly increases the likelihood of developing cancer.

False

The "minimum necessary" standard allows an Investigator to copy an entire medical record to ensure that all necessary data are captured for study purposes.

False

GCP safety monitoring procedures can be effectively applied only to trials involving drugs and medical devices.

False! Expedited reporting of alarming events by Investigators to IRBs serves to protect subjects in a variety of VA research projects.

Enabling a device login password or PIN, and an inactivity timeout to force (re)login with that password or PIN after the device is idle for a defined period, is generally considered:

Generally considered essential for any portable device.

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Which of the following should take place during periodic site visits?

Identification of protocol violations

The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?

Identification of study risks to determine which may safely be omitted from continual monitoring.

The Investigator:

Identifies, evaluates, and reports safety data to the IRB and Sponsor. The IRB evaluates the acceptability of risks to study patients when safety information is received, and the research subject is the focus of safety monitoring activities in a clinical trial.

When a patient enters a clinical facility, they must inevitably surrender control of their information for a broad range of uses and disclosures. In the circumstances where the patient retains control of information, which of the following is true?

If the person controls a decision about treatment, he/she controls information about the information associated with it.

Supplemental security software (such as anti-virus [anti-malware]) is

Increasingly common for smartphones and tablets, and can include protections like remote-locate, remote-disable, and remote-data-wipe.

Supplemental security software (such as anti-virus [anti-malware]) is:

Increasingly common for smartphones and tablets, and can include protections like remote-locate, remote-disable, and remote-data-wipe.

Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:

Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is considered a SBR data collection method?

Interviews

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:

Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

During web sessions where sensitive information is being exchanged one should:

Look for both the "padlock" and "https" in the web address.

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them.

With respect to workplace use of messaging, such as text messages or messaging applications, which of the following is incorrect?

Messaging communications have been determined to have no legal standing and so can never be considered official communication.

A primary purpose of the ICH is to:

Minimize the need for redundant research.

Ensuring data backups for data stored on a desktop or laptop computer is generally considered:

Necessary when the device would otherwise be the only source of hard-to-replace data, but the backup mechanism must also be secure.

Ensuring data backups for data stored on a portable device is generally considered:

Necessary when the device would otherwise be the only source of hard-to-replace data, but the backup mechanism must also be secure.

For health information privacy and security, are the legal and regulatory requirements for students different from those for regular members of the healthcare workforce?

No, students must meet the same standards as a regular member of the workforce performing the same tasks.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

The history of ethical regulations in human subjects research began with the

Nuremberg Code

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

Desktop computers are often provided in the workplace by organizations, and laptops may be as well. However, portable devices (such as tablets and smartphones) may more commonly be allowed on a BYOD basis. For a BYOD (personally-owned) device:

Organizations may have requirements about how BYOD devices may be configured or used, as a condition of accessing the organization's information resources.

As a complement to picking a strong password, which of the following is part of an overall security strategy for a computer or other device?

Paying attention to physical security, as a complement to good technical security like anti-malware and strong passwords.

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

Phase I

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

Additional safeguards that may be included in a social and behavioral study may include:

Remove all direct identifiers from the data as soon as possible.

Which of the following statements is true regarding the responsibilities of reviewers?

Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.

What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)

Reviewing subject recruitment materials and strategies. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. Protecting the rights and welfare of human subjects.

Which of these is not a good security practice for email?

Sending sensitive information in email messages or in attachments to such messages, as long as a legally-binding confidentiality notice is included.

What is the most common way for human beings to authenticate a person's "identity" in daily human life?

Something a person "is," like the way he/she looks or speaks

What is the most common way for computing systems and devices to authenticate a person's identity?

Something a person knows, like a password or PIN.

During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization; On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of these subject's events meets the FDA definition of "serious" and "unexpected" and would require the sponsor to file an IND Safety Report with the FDA?

Subject 603 only

Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations?

The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

The Public Health Service Study of Untreated Syphilis in the Negro Male.

Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report?

The Tuskegee Study

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:

The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

Which of the following is not a GCP requirement applicable to Investigator's subject records?

The name and Social Security Number of the subject must be printed on each case report form.

Patients must be provided with federally-mandated Privacy Notices when they first encounter direct treatment providers. Which of the following is an implication of that for clinicians?

The provision of the notice just before receiving treatment means clinicians will receive some questions about privacy issues. There is an obligation to know the answers, or to be able to direct the patient to someone who does.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

Issued in 1974, 45 CFR 46 raised to regulatory status

US Public Health Service Policy

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?

Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.

A HIPAA authorization has which of the following characteristics:

Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

Which of these is not generally a good practice for telephone use?

Using voicemail systems and answering machines that do not require a password or PIN for access.

Proper paraphrasing of a sentence written by someone else may be accomplished by:

Using your own words and writing voice to express the idea conveyed in the sentence.

In the United States, following the ICH E6 guideline is:

Voluntary for FDA-regulated drug studies.

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?

Will the researchers have collaborators at the research site abroad?

In regard to reporting privacy or security problems, are the requirements for students the same as for regular workers?

Yes. Like any other member of the workforce, students are obligated to report problems they are not in a position to correct.

Which of the following are included in the Code of Federal Regulations under Part 19?

address any concerns relating to the radioactive working environment access to information about your personal exposure record instruction relating to radioactive material you work with

Files attached to an email can contain:

all of the above

What "administrative" measures do you usually need to take?

all of the above Limit what kinds of data can be stored on the computer. Limit how the computer can be used - for example, no peer-to-peer downloads. Limit who can use the computer.

The most important effect of the absorption of radiation by matter is called ionization. When this occurs:

an electron is removed from an intact atom

Good Clinical Practice (GCP) pertains to

requirements in clinical research with investigational drugs designed to protect human subjects in research and to help maintain integrity of the research data.

For large spills/incidents/accidents involving radioactive material you should move to the outer perimeter of the immediate area, alert others so contamination is not spread, and call the Radiation Safety Office.

true

The best ways of preventing contamination are listed, except: practice procedures before actual radioactive material use wash hands immediately after radioactive material use monitor clothing and work area with a survey meter wear a lab coat over shorts and sandals wear disposable gloves

wear a lab coat over shorts and sandals

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

workers the common rule applies to : Prisoners, Individuals with Impaired Decision-Making Capacity and Children

These are the principle ways to reduce your exposure to radiation, except: limit Time spent near radioactive sources contaminate doorknobs, phones, and countertops to increase the chance for internalization properly Shield all radioactive sources increase Distance between you and the radioactive source

contaminate doorknobs, phones, and countertops to increase the chance for internalization

Which of the following is true?

Federal regulations include treatment-related uses and disclosures in a large category (along with payment and healthcare operations) that require no specific permission from patients.

Which of the following statements in a consent form is an example of exculpatory language?

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

Devices used purely for storage, like USB flash ("thumb") drives and external hard drives:

May expose large amounts of data if compromised, so should also use protections like access passwords or PINs and whole-device data encryption.

Multi-tasking is a risk for all of the following reasons except:

Multi-tasking is generally prohibited by law, because of the safety issues.

Investigator study records:

Must be maintained in a secure environment that protects patient privacy and protects documents from destruction.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Must occur within 12 months of the approval date.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study?

Phase III

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Securing a Certificate of Confidentiality

When is use of "reply all" appropriate?

Sometimes. Some responses need to be seen by everyone, but not every response requires a full broadcast.

The investigator must report adverse events to the:

Sponsor

Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:

Sponsor The investigator reports UADEs to the sponsor and the local IRB. The sponsor transmits evaluations of these reports to the FDA.

Disclaimers and confidentiality notices are a common feature of business emails. Which of the following is correct?

Such notices should be included if an organization's policies require it, but cannot be counted upon as legal protection.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

Which of the following is true?

The "minimum necessary" standard applies to treatment-related uses, but not treatment-related disclosures, so as to avoid any interference with information exchanges among practitioners.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

The researcher cannot control what participants repeat about others outside the group.

Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor:

The sponsor

A film badge is useful for monitoring x-ray, gamma, and moderate to high energy beta emissions.

True

Part 20 requires contamination surveys be performed to detect accidental spread of radioactive material in the course of routine use.

True

The sponsor is responsible for specifying in each protocol the adverse event reporting procedures to be used by those conducting the trial, and to disseminate safety reports to other stakeholders in the research project.

True

A 510(k) Premarket Notification is submitted:

When the new device to be marketed is substantially similar (equivalent) to one already on the market A 510(k) Premarket Notification is submitted when a manufacturer wishes to market a qualified medical device in the U.S. without conducting clinical trials. To do so, the manufacturer must demonstrate to FDA that the device is equivalent to one already marketed. An IDE must be submitted when clinical trials of investigational devices are needed to determine the safety and effectiveness of a new device or when studying substantial modifications to or new intended uses for devices already on the market. A Premarket Approval (PMA) might be submitted for the FDA to evaluate the results of a completed clinical trial of a Class III device.

Records must be maintained for all but which of the following?

constant surveillance of material which is not in storage locked storage areas where RAM is located secure material from unauthorized access or removal by persons not approved for use locked laboratory door(s) when not in attendance

Which of the following is not correct with respect to deleting messages?

A simple delete assures that messages are no longer accessible. Nothing more is required.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Both the magnitude (or severity) and the probability (or likelihood) of harm.

Which department reviews a sample of clinical trials being conducted in each department and provides education, tools, and corrective and preventative action plans, when needed?

Clinical Trials Audit and Compliance

In completing Form FDA 1572, Statement of Investigator, the investigator agrees to

Conduct or supervise the investigation personally

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Justice

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

Organizational use of social networking sites for "social media marketing" is now very common. Which of the following is true about social networking at work?

Organizations tend to be conservative about their reputations, so can have formal or at least informal rules about what employees can post even on personal sites.

When authors summarize the work of others, they typically should:

Provide a condensed (shorter) version of the original material.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

Provide parents certain rights over their children's educational records.

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:

The medical center to replace the use of paper records with electronic records for its research.

Which of the following is a correct statement about safe password management?

The nature of the resource a particular password protects will affect, to some degree, how strong it needs to be.

A waiver of the requirement for documentation of informed consent may be granted when:

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

A publication restriction, such as DFARS 252.204-7000, is most likely to cause which of the following to occur:

The project will no longer fall under the Fundamental Research Exclusion (FRE)

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

The research must pose no more than minimal risk.

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

The research study's finding could affect an employee's pay, benefits, or promotion potential. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. The employer may encourage or deny participation of workers.

Who is responsible for making the initial risk determination for a device being used in a study?

The sponsor-investigator.

Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

The study is minimal risk.

Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?

The study is not intended to be reported to FDA to support a new indication or support a labeling change.

Which of the following is most likely to be a deemed export:

The transfer of information to a foreign national in the United States

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

There was neither a violation of privacy nor a breach of confidentiality.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?

This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.

Which of these is a characteristic of a strong password?

Uses mixes of uppercase, lowercase, and special characters, ideally in a sequence that is only meaningful to its creator.

Which of the following correctly describes a dictionary or brute force attack?

Where a computer is used to try all the words in a dictionary or character combinations as possible passwords.

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure.

The standard unit of amount or quantity of radioactivity is the Bequerel (Bq) which measures the _________ per _________.

decays per second

It is permissable to use or store radioactive material in an area that has not been designated for its use or storage.

false

Liquid scintillation vials containing radioactive material can be discarded into regular trash.

false

What type of radiation is the most penetrating?

gamma photon

Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?

Falsification

As a radiation worker you have which of the following responsibilities?

- report unsafe conditions - follow rules and regulations designed for safe use of radiation - maintain doses ALARA

Research practices directly affected by the Privacy Rule include: (Select all that apply)

- Record keeping and record access. - Authorization. - Patient recruitment.

The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and:

(3) there is a reasonable possibility that the drug caused the event.

The following statements are true of safety monitoring: (Select all that apply)

- Safety monitoring is a responsibility of the Investigator, IRB, and the Sponsor. - Safety monitoring serves the interests of both study patients and the general public. - Reporting requirements of the Sponsor and IRB may differ in a trial yet still provide the safety protections required by GRP.

Good Clinical Practice regulations place obligations on the following individuals and groups: (Select all that apply)

- Sponsors. - IRBs. - Investigators.

A Study Coordinator can legally perform a specific study task if: (Select all that apply)

- The Study Coordinator is qualified by training and experience. - The task is delegated by the Investigator.

Lab surveys must be performed:

- each week radioactive material is used in the lab - each month even if radioactive material is not used but present

At VHA medical centers, source documentation for study data can be maintained in (select only one answer):

A paper clinic record. A subject study file created by study personnel. The Electronic medical record or Computerized Patient Record System (CPRS).

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer's conflict of interest should be disclosed to the journal editor or grant agency.

According to ICH E6, an "audit" is defined as:

A systematic and independent examination of trial-related activities and documents.

What does the federal provision for "incidental uses and disclosures" mean?

Accidental uses and disclosures are not subject to penalties provided reasonable safeguards are in place and there has been no negligence.

Parental notification, in lieu of active parental permission, is allowed when:

An IRB has approved a waiver of the requirement for parental permission.

A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. The investigator would submit an SAE report for:

Both of the subjects

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:

Both subparts apply, as these individuals are under the legal age of consent and are incarcerated

Which of these is not a good security practice for web browsing?

Browsing to sites using links sent in emails without taking steps to assure the destination is safe.

It is possible for a computing device to be exposed to malicious software (malware) or reveal sensitive information:

By simply visiting a webpage.

ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must:

Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records

Use of social media tools and other new technologies to facilitate training-related communications is:

Depends on the organization's policies, so you should check with your organization's officials about what is allowed or prohibited.

Many email systems allow the designation of a higher priority, such as with a "!" symbol, or to request a read receipt for an important message. Which of the following is not correct about such functions?

Designations of high importance are guaranteed to flag prominently a message in all of the recipients' email systems.

Award documentation is typically required to be prepared and submitted within how long after the end of a project period:

90 days

An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

A breach of confidentiality

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:

Economic vulnerability

Non-licensed clinicians can dispense and educate subjects about their medication.

False

For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement?

NCT number

Which of the following statements about mentoring is true?

Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks.

The purpose of informed consent is:

To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

The research team should discuss the issue early on and while the project is ongoing.