Clinical research

How many major parts does the ICH E 6 guidelines have?

8 1) ICH GCP Principles 2) IRB 3) Investigator 4) Sponsor 5) Protocol 6) Investigator Brochure (IB) 7) Essential Documents 8) ....

Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

Coordinating Committee

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects

Audit Certificate

A declaration of confirmation by the auditor that an audit has taken place.

Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

Contract Research Organization (CRO)

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.

Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Impartial Witness

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject ís legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. A product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

Interim Clinical Trial/Study Report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

Adverse drug reaction (ADR) of marketed medicinal products:

A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function

Compliance (in relation to trials)

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Legally Acceptable Representative (LAR)

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial

What is Good Clinical Practice (GCP)?

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects

Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Clinical Trial/Study

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and pharmacodynamic effects, record adverse reactions, safety or efficacy of an investigational product(s).....

Applicable regulatory requirement(s):

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

Institution (medical)

Any public or private entity or agency or medical or dental facility where clinical trials are conducted

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. a change in a persons health

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose: • results in death, • is life-threatening, • requires inpatient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, or • is a congenital anomaly/birth defect

What does Good Clinical Practice assure?

Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

A systemic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirements.

Audit

Nonclinical Study

Biomedical studies not performed on human subjects.

Regulatory Authorities

Bodies having the power to regulate. Authorities that review submitted clinical data and those that conduct inspections.

What is the objective Good Clinical Practice Guideline?

To provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Institutional Review Board (IRB)

a committee of diverse individuals that review studies PRIOR to the study entolling participants.All studies involving human subjects (with few exceptions for studies involving minimal risk) must be IRB approved prior to enrolling subjects. the goal of the IRB is to protect human subjects.

Unanticipated Events

problem invikving risk to human subjects or others participating ina clinical research study. example: breach of confidentiality, incarceration of subject, suicide attempt, incorrect labeling of study drug. these need to be collected throughout a study and reported to the IRB and/or study sponsor.

primary purpose of Certificate of Confidentiality is:

protect identifiable research information from compelled disclosure

National Institutes of Health (NIH)

a department within the department of health and human services. the NIH oversees behavioral, medical, and investigational medication trials. awards several grants mutiple times a year to investigators who submit research grant proposals. Awards over 30 billion dollars to researchers every year. These awards are very competitive and only the cert best studies recieve funding.

Data Safety Monitoring Board (DSMB)

a group of individuals who periodically review interim unblinded study data to ensure the safety of the participants in the trial. not all studies require a DSMB. DSMB reports are submitted to the IRB throughout the study to help the IRB determine if the study is safe.

site management organization (SMO)

a group of investigational sutes that have banded together and are organized centrally to conduct studies

World Medical Association (WMA)

a group of physicians. produced the declaratipn of Helsinki which was also written for physicians through other types of researchers can and should still follow the prinipals

Investigational New Drug (IND)

a new drug that is used in an investigation. In order to test a nee drug an IND application must be filed with the FDA prior to starting the study.

Case Report Form (CRF)

a recored kf information collected from a subject during a trial. the information that is collected is based on what the protocol specifies.

clinical trial

a systematic investigation of an intervention in human subjects

A copy of the original record that has been verified to have the same information, including data that describe the context, content, and structure, as the original. a. Certified Copy b. Clinical Study Report c. Essential Study Document d. Source Document

a. Certified Copy

A person responsible for the conduct of the clinical trial at a trial site. a. Investigator b. Study Coordinator c. Site Monitor d. Medical Monitor

a. Investigator

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, subjects' diaries or evaluation checklists, etc. kept at the pharmacy, at the laboratories and at medical or technical departments involved in the clinical trial). a. Source Documents b. Clinical Study Reports c. Certified Copies d. Clinical Trial Records

a. Source Documents

An adverse reaction, the nature or severity of which is not consistent with the applicable product information. a. Unexpected Adverse Drug Reaction b. Adverse Event c. Serious Adverse Drug Reaction d. Serious Adverse Drug Event

a. Unexpected Adverse Drug Reaction

Affirmative agreement to take part in a clinical investigation. a. assent b undue influence c. coercion d. informed consent

a. assent

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. a. impartial witness b. trial subject c. sub-investigator

a. impartial witness

Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. a. serious adverse event b. adverse drug reaction c. unexpected adverse drug reaction d. adverse event

a. serious adverse event

Individuals who participate in a clinical trial, either as recipients of the investigational product(s) or as controls a. trial subjects b. principal investigators c. coordinating investigators d. sub-investigators e. vulnerable subjects

a. trial subjects

Clinical research

aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.

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

all research funded by HHS

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

all research funded by HHS

Adverse Drug Reaction (ADR)

an unintended reaction to a drug taken at a normal dose

Serious Adverse Event (SAE)

any iutward medical occurance at any dose that results in death, is life threatening, requires hospitalization (or prolonged hospitalization) results in persistent or significant disability, or is a birth defect.

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

asking women if they've had an abortion

Investigator Brochure (IB)

contains all information known about the test product including chemical makeup, mechanisms of action, clinical and preclinical data. this eventually becomes something you are probably familiar with-the package insert

World Health Organization (WHO)

created by the UN. focused in global health. They have their own health standards for clinical trials and leadership in countries across the world. the WHO was instrumental in forming the international standards for clinical trial registries.

Under HIPAA, "disclosure accounting" is required:

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

normal value

for studies requoring blood draws and subsequent lab tests, blood oressures, EKGs l, etc. a list of normal values should be maintained. this lis woukd indicate to anyone what would be an ynacceotabke level.

prospective reimbursement analysis = PRA

identifies all billable services (CPT/CDM codes) listed in the protocol and whether or not they can be billed to third party payers. -based on medicare guidelines -mandate from SOM in 2007 -used by CTBD (clinical trials billing Dept) to reconcile charges and bill correct payers

a researcher proposes to conduct a study at a foreign site that 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 US researcher conducting a study in a non-US setting when obtaining inforemd consent from subjects?

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

risk of harm in social and behavioral sciences generally gall in three categories:

invasion of privacy, breach of confidentiality and study procedures

Under HIPAA, "retrospective research" (aka data mining) on collections of PHI generally:

is research, and so requires either an authorization/meeting one of the criteria for a waiver of authorization

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 research will be conducted

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

remove all direct identifiers from the data as soon as possible

essential documents

required to be in your reg binder. if you are audited, auditors will definitely look for the documents and make sure they are the correct version.

according to Subpart D, research with children may be eligible for exemption when:

research involves the use of educational tests

a researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools b/c nature of the research... which requirement must be met before an IRB could waive perental permission?

research must pose no more than minimal risk

What Belmont principle describes the application of informed consent

respect of persons

investigator

s(sometimes called clinical investigator or more often pricipal investigator (PI)) is an individual who conducts the clinical investigation. under the immediate direction the investigation product is dispensed. they are the site leader od the investigation. other may work for the investigator,such as clinical research coordinators but ultimately responsibility for the trial lies with the investigator.

contact research organization (CRO)

sponsors hire a CRO to handle the management of the clinical trial. like the sponsor they do not carry out the clinical trial but rather manage the trials and the sites that are actually running the study.

a researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. the researcher will not interact with the children. this researcher would be eligible for which type of IRB review?

this research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting

ICH GCP composition of IRB

- rights, safety, and well-being of all trial subjects - obtain documents (protocol, IFC, written info for subj, compensation info, PI CV - statement that IRB is organized and operates according to GCP - continuing review a) At least 5 members. b) At least one member whose primary area of interest is in a nonscientific area. c) At least one member who is independent of the institution/trial site. Written records of minutes May invite non members with expertise Members enrolled in the protocol cannot vote

What are the three entities that ORA collaborates with

1. Emory University Departments: for research administration processes 2. Emory Healthcare: subject's research visits and tests 3. Emory affiliates: research enrollment and procedures for subject population (sites include Grady, CHOA, Atlanta VA etc.)

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. It protects the rights, safety, and wellbeing of ppt

Informed Consent

A subject voluntarily confirms his or her willingness to participate in a trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. Copy to subject must be SIGNED and DATED (FDA not signed copy)

Audit

A systematic and independent examination of trial related activities and documents

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol.

Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.

Audit Report

A written evaluation by the sponsor's auditor of the results of the audit.

Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsorís SOPs

Contract

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

What is Adverse drug reaction (ADR)?

All noxious and unintended responses to a medicinal product related to any dose. A causal relationship between a medicinal product and an adverse event.

Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information

Investigator / Institution

An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements"

Independent Ethics Committee (IEC)

An independent a review board or a committee...of medical professionals and non-medical members to ensure the protection of the rights, safety and well-being of human subjects involved in a trial // reviewing and approving trial protocol, methods,,,, The legal status, composition, function, operations may differ among countries,

Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

Case Report Form

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters.

Contract

A person or an organization (commercial, academic, or other) hired by the sponsor to perform one or more of a sponsor's trial-related duties and functions.

Contract Research Organization

What brought attention to the problems of the IRB system?

Death of Jesse Gelsinger

ICH GCP is based on

Declaration of Helsinki

Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Essence of GCP -IRB: -Investigators: -Sponsors:

Essence of GCP -IRB: has to approve the study has human subject protection -Investigators: in charge of data integrity and validity -Sponsors: in charge of investigational product control and accountability

Good Clinical Practice Guideline was developed by?

European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).

Language through which a subject is made to waive or appear to waive any of his or her legal rights, or release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Exculpatory

A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Independent Data Monitoring Committee

Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy...patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or CRO's facilities, or at other establishments deemed appropriate by the regulatory authority.

Inspection

An independent body constituted of a medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Institutional Review Board

A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of the investigational product in human subjects.

Investigator's Brochure

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

Monitoring

Blinding/Masking

One or more parties to the trial are kept unaware of the treatment assignment(s).

Source Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda.....

Direct Access

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial....

Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

Use of prisoners in research is a concern under the the Belmont principle of justice because:

Prisoners can only be used in research that benefits the larger society

International conference on harmonization (ICH) guideline for GCP

Provides a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of the clinical data by the regulatory authorities in these jurisdictions

Inspection

Regulatory authority(ies) conducting an official review of documents, facilities, records, and any other resources related to the clinical trial ... located at site or sponsor or CRO...

ICH GCP: IRB records

Retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Standard Operating Procedures

What is the Common Rule?

The "Common Rule" was published in 1991, based on the Belmont Report, and codified in separate regulations by 15 Federal departments. The HHS regulations, 45 CFR part 46, include four subparts: A, also known as the Federal Policy or the "Common Rule" B, additional protections for pregnant women, human fetuses, and neonates; C, additional protections for prisoners; D, additional protections for children.

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).

Approval (in relation to Institutional Review Boards)

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution sit

Opinion (in relation to Independent Ethics Committee)

The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

Trial Site

The location(s) where trial-related activities are actually conducted.

Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

Well-being (of the trial subjects)

The physical and mental integrity of the subjects participating in a clinical trial.

Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy

Single-blinding

Usually refers to the subject(s) being unaware

Doubleblinding

Usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

When should Good Clinical Practice Guideline be followed?

When generating clinical trial data that are intended to be submitted to regulatory authorities. May also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality or that subjects are protected. a. good manufacturing practice b. good clinical practice c. good laboratory practice d. good pharmacovigilance practice

b. good clinical practice

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been told of all aspects of the trial that are relevant to the subject's decision to participate. a. undue influence b. informed consent c. coercion d. assent

b. informed consent

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. a. monitoring b. quality control c. auditing d. quality assurance

b. quality control

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. a. subinvestigator b. sponsor c. coordinating investigator d. principal investigator

b. sponsor

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator

b. sub-investigator

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:

both magnitude and probability of harm

Any study of a drug or device in humans submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective or any study in which a single investigator makes a significant contribution to the demonstration of safety. a. Phase 2 Clinical Study b. Clinical Pharmacology Study c. Covered Clinical Study d. Phase 1 Clinical Study

c. Covered Clinical Study

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. a. Waiver b. Informed Consent c. Direct Access d. Audit

c. Direct Access

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. a. Stratification b. Masking c. Randomization d. Blinding

c. Randomization

Payments that have a cumulative monetary value of $25,000 or more and are made by any sponsor of a study to the investigator or the investigator's institution during the time the clinical investigator is carrying out the study and for one year following completion of the study. a. Equity Interest b. Financial Interest c. Significant Payments of Other Sorts d. Proprietary Interest

c. Significant Payments of Other Sorts

A procedure in which one or more parties to the trial are kept unaware of the treatment assignments. a. placebo b. informed consent c. blinding d. randomization

c. blinding

This occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. a. informed consent b. assent c. coercion d. undue influence

c. coercion

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements. a. quality control b. auditing c. quality assurance d. monitoring

c. quality assurance

Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection. a. voluntariness b. beneficence c. respect for persons d. justice

c. respect for persons

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

A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. a. Compliance Report b. Monitoring Report c. Audit Report d. Clinical Study Report

d. Clinical Study Report

A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. a. Audit Report b. Monitoring Report c. Clinical Development Plan d. Monitoring Plan

d. Monitoring Plan

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. a. adverse drug reaction b. serious adverse event c. unexpected adverse drug reaction d. adverse event

d. adverse event

A document that describes the objective, design, methodology, statistical considerations, and organization of a trial and usually also gives the background and rationale for the trial. a. clinical study report b. informed consent form c. essential document d. protocol e. audit report

d. protocol

This occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. a. assent b. coercion c. informed consent d. undue influence

d. undue influence

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, wether justified or not, of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case or refusal to participate. a. sub-investigators b. coordinating investigators c. impartial witnesses d. vulnerable subjects e. investigators f. trial subjects

d. vulnerable subjects

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

development of generalizable knowledge

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. a. informed consent forms b. monitoring reports c. case report forms d. audit certificates e. essential documents

e. Essential documents

All information in original records and certified copies of original recors of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. a. protocol b. clinical study report c. informed consent form d. audit report e. source data

e. source data

the National Research Act of 1974:

established the National Commission

Result of Beecher article:

ethical abuses are not limited to Nazi regime

Office of Human Research Protections (OHRP)

exsists withinthe department od health and human services. their goal is to provide guidebcr concerns the rights and wellbeing of research participants. OHRP tracks the federal wide assurance certificates. these FDA certificates are required for any group conducting trials on human subjects.

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

federal regulations do not require the documentation of minors' assent

phase 1 trial

first time drug or test article is studied in human subjects small # of subjects goal: determine metabolic, pharmacological propeties if drugs in humans primary concern: subject safety

regulatory or "reg" binder

maintained by the CRC for each stufy that they coordinate. Houses all essential documents and other important study documents. is subject to audit if the sponsor or FDA were to conduct one.

data management

managing the data, the process if handling data generated and collected during a trial. it usually involves data entry, data cleaning, and database management.

phase 2 trial

more subjects enrolled than phase 1 goal: determjne if drug is efficacious primary concern: is phase 1 dose effective?

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

must be detailed for disclosures that involve less than 50 subject records

phase 4 trial

occurs AFTER new drug application approval goal:obtain additional saftey and efficacy data secondary goal: study different formulations, dosages, interactions, etc

clinical trial

one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants not only play a more active role in their own health care, but they also can access experimental treatments and help others by contributing to medical research.

phase 3 trial

only occurs if phase 1 and 2 proved that the drug/treatment is safe goal: study ling term safety and efficacy primary concern: long term effects

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

subpart D: additional protections for children involved as subjects in research

HIPAA's protections for health information used for research purposes:

supplement those of Common Rule and FDA

Declaration of Helsinki (1964)

the World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants.

efficacy

the ability of an investigational product to produce beneficial effects. basically means "does the product work?" if yes yhej it is efficacious

protocol

the formal plan for carrying out the investigation

international conference on harmonization

the good clinical practice guidelines were created here. the goal was to design guidelines that would regukate the conduct if clinical trials nationally

impetus to harmonize

the idea to standardize research internationally took place in the wake of the thalidomide fall out in which women were given a medication, thalidomide to help east morning sickness. the medication led to sever birth defects. thalidomide was never approved in the us because the FDA refused based in insufficient safety data

controlled trial

the investigational product is teated against a control. the contol can be a placebo or standard of care

New Drug Application (NDA)

the marketing application that is filed with the FDA to bring a new drug to market

clinical research coordinator (CRC)

the ones that actually carry out the studies at the study sites and collect the study data. manages the daily operations of tge trial. they are often the ones seeing the participants and carrying out the protocol. they are respondible to the investigation.

sponsor

the person it entity who initiates a clinical trial but they do not actually run the trial

informed consent

the process by which a subject voluntarily agrees to be in a research study. They read the informed consent form (ICF) and the CRC reviews it with them. if the subject is willing they sign the ICF to affirm their willingness to be in the trial.

according to Subpart D, research with children may be eligible for exemption when:

the research involves the use of educational tests

HIPAA "minimum necessary" standard applies...

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

Clinical research associate (CRA)

typically work for the CROs. they are responsible for monitoring the study at study sites. They visit sutes and look at the data collected and make sure the site is following protocol. they work closely with the CRCs at the study site

a study that involves interviews of adults is eligible for expedited review. the researcher wants to add an adolescent population (age 12-17) to the study and has.... no additional changes are planned. what statement about review of the revised protocol is right?

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.

What is included in the Nuremberg Code

voluntary consent

study sites

where studies are actually run. Sites are where participants are recruited and data is collected.

Standard Operating Procedures (SOPs)

written directions on exactly how procedures are to be performed. the goal is to maje sure everyone who performs that task does it exactly the same way everytime.