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IRB records must be maintained for ___ years after study completion, after marketing approval, or suspected marketing approval in other regions is complete.

A. 1 B. 4 C. 3 X 21 CFR Part 56.115 IRB records. (b)The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner.

The FDA's Notice of Inspection Form is a Form FDA _____.

A. 1572 B. 483 B. 482 X

A Pre-Trial Monitoring Report documents that a site(s) is suitable to conduct and clinical trial, and is done by the _____.

A. IRB B. Sponsor X C. Monitor

Information included in Informed Consent must be approved by:

A. Principal Investigator B. IRB X C. Sponsor 21 CFR Part 56.109 IRB review of research. (a)An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.

Once an investigator has been disqualified by the FDA, he or she may never again receive investigational drug.

A. True B. False X 21 CFR Part 312.70 Disqualification of a clinical investigator. (f)An investigator who has been determined to be ineligible to receive investigational drugs may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ investigational drugs solely in compliance with the provisions of this part and parts 50 and 56.

Any changes to the investigator brochure content should be approved by the IRB's and/or regulatory authority(ies).

A. True B. False X ??

Based upon the Medical Device Amendment of 1976, in the case of certain emergency situations, Informed Consent can be waived, and the determination of the Principal Investigator to waive Informed Consent must be reviewed by a non affiliated doctor within 5 working days.

A. True X B. False 21 CFR Part 50.23 Exception from general requirements. (3) The investigator must submit the documentation required in paragraph (e)(1) or (e)(2) of this section to the IRB within 5 working days after the use of the device.

Investigators' Final Reports should be sent in no more than ____ months after the investigation is complete or the investigator's part in the investigation is complete.

A. 1 year B. 3 months X C. 6 months

An IRB must renew every:

A. 2 years B. 6 months C. 3 years X 21 CFR Part 56.106 Registration. (c)Each IRB must renew its registration every 3 years. IRB registration becomes effective after review and acceptance by HHS.

If a study dosing regimen requires a subject to take one capsule TID for 14 days, a subject returns after 14 days with 10 capsules remaining in a bottle that originally contained 50 capsules, and reports that no tablets were lost, what is the subject's percentage of compliance?

A. 60 B. 95 X C. 100 D. 84

If an Investigator's IRB Approval is withdrawn, the investigator must report IRB Withdrawal to the Sponsor within ____ working days.

A. 7 B. 14 C. 5 X

If there is a protocol change, a subject must re-consent :

A. Always B. If the subject is a part of the protocol change X C. Never

IRB Reviews occur at least:

A. Annually X B. Semi-Annually B. Every 2 years 21 CFR Part 56.109 IRB review of research. (f)An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less then once per year, and shall have the authority to observe the consent process and the research.

It is the responsibility of the _____ to verify that Informed Consent was obtained before each person's participation in the trial.

A. Monitor X B. Sponsor C. IRB ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (e)Verifying that written informed consent was obtained before each subject's participation in the trial.

If a subject elects to withdraw from a trial during an interim study visit, which is the most reliable source of information for specific actions that should be taken by the investigator?

A. The FDA's GCP regulations B. The IRB's safety requirements C. The protocol X D. The Investigator's Brochure

A copy of Informed Consent must always be given to the subject or subject's representative.

A. True X B. False 21 CFR Part 50.27 Documentation of informed consent. (a)Except as provided in 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or subject's legally authorized representative at the time of the consent. A copy shall be given to the person signing the form.

Assent in clinical trials refers only to those subjects less than 18 years of age.

A. True X B. False 21 CFR Part 50.3 Definitions. (n) Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.

Any equity / financial interest in the sponsor of a covered study that exceeds $______ during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study should be reported on the financial discloser form.

A. $25,000 B. $50,000 X C. $75,000 21 CFR Part 54.2 Definitions. (b)Significant equity interest in the sponsor of a covered study means any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a non-publicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.

If any significant payments of other sorts, (payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator) that have a monetary value of more than $______, exclusive of the costs of conducting the clinical study, during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study, should be reported on the financial disclosure form.

A. $25,000 X B. $50,000 C. $75,000 21 CFR Part 54.2 Definitions. (f)Significant payments of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more than $25,000, exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study.

Investigators and Sponsors must maintain study records for a period of ____ years after the investigation is terminated / completed, or no longer needed for marketing approval.

A. 10 years B. 2 years X C. 4 years 21 CFR Part 312.57 Record keeping and record retention. (c)A sponsor shall retain the records and reports required by this part for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA is notified. 21 CFR Part 312.62 Investigator recordkeeping and record retention. (c)Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or of the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

What is the appropriate FDA form for an investigator to use when filing a treatment IND?

A. 1571 X B. 1572 C. 1583 21 CFR Part 312.23 IND content and format. (a)A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including in the following order: (1)Cover sheet (Form FDA-1571).

If the investigator employs an exception from obtaining informed consent (i.e. an emergency use), a full report of the circumstances must be reported to the IRB within ___ working days, and a written review by a physician not associated with the investigation must be submitted to the IRB within ___ working days?

A. 2, 14 B. 5, 5 X C. 7, 30 21 CFR Part 50.23 Exceptions from general requirements. (b)If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the test article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. (c)The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.

An Investigator's Financial Disclosure Reports are to be sent to the Sponsor for a period of _____ years after the completion of the study.

A. 3 B. 2 C. 1 X 21 CFR Part 312.53 Selecting investigators and monitors. (4)Financial disclosure information. Sufficient accurate financial information to allow the sponsor to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.

What is the recommended frequency for monitoring visits by sponsors of a clinical investigation?

A. 3 months B. 6 months C. Frequent enough intervals to determine that the investigator is meeting his/her obligations in the study X

The FDA prefers Information Amendments to be filed by the Sponsor every ____.

A. 90 days B. 60 days C. 30 days X 21 CFR Part 312.31 Information amendments. (c)When submitted. Information amendments to the IND should be submitted as necessary, but, to the extent feasible, not more than every 30 days.

A sponsor-investigator must be a/an ____.

A. A corporation, such as a pharmaceutical company B. An individual X C. Either 21 CFR Part 312.3 Definitions and interpretations. (b)Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.

______ studies are all study designs in which a difference is intended to be shown between the test article and some control.

A. Active treatment control, Historical control, and No treatment control B. Dose comparison control, Active treatment control, and Historical control C. Placebo control, Dose comparison control, and No treatment control X FDA Information Sheet Guidances. Drug Study Designs. FDA regulations ( 21 CFR Part 312.126) cite five different kinds of controls that can be useful in particular circumstances: Placebo control, no-treatment control (suitable where objective measurements are felt to make blinding unnecessary), and dose-comparison control studies are all study designs in which a difference is intended to be shown between the test article and some control. The alternative study design generally proposed to these kinds of studies is an active treatment concurrent control in which a finding of no difference between the test article and the recognized effective agent (active-control) would be considered evidence of effectiveness of the new agent.

When an investigator receives notification of a protocol amendment that adds an invasive procedure at the mid-way point in treatment, what is the proper sequence of events to implement the amendment?

A. Amend the consent form. Obtain a revised consent from all subjects currently enrolled in the study who will be affected y the change. Then, submit the protocol amendment and revised consent form to the IRB for approval. Following receipt of the IRB approval of both documents, implement them with future subjects. B. Promptly submit the amendment to the IRB, requesting approval. Following receipt of the IRB approval document, implement it, and send a copy of the signed amendment and IRB approval to the sponsor. C. Revise the informed consent form based on the protocol amendment and revised informed consent form. Upon receipt of the approval, re-consent all currently enrolled subjects who are affected by the protocol amendment using the revised consent form. Send a copy of the revised consent form, signed protocol amendment and IRB approval document for both documents to the sponsor. Use the revised informed consent form and implement the protocol amendment with future subjects. X D. All of the above

Which of the following are documents that IRB's must retain?

A. Approved sample consent documents B. Records of continuing review activities C. IRB/Investigator Correspondence D. All of the above X 21 CFR Part 56.115 IRB records. (a)An institution, or where appropriate and IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1)Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (3)Records of continuing review activities. (4)Copies of all correspondence between the IRB and the investigators.

What procedures must be followed if data recorded on a CRF is modified?

A. Change must be dated/signed by the person making the change, as well as the person who made the original entry B. Change must be dated/initialed/explained, if required and the original data must be viewable X C. Change must always be supported by an original source document D. All of the above ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4. Investigator. 4.9 Records and Reports. 4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trail should be maintained); this applies to both written and electronic changes or corrections (see section 5.18.4(n)).

The ICH GCP guideline states that an IRB or IEC is required to have written procedures specifying that investigators should promptly report to the IRB or IEC which of the following?

A. Changes that decrease risk to subjects B. All adverse drug reactions that are both serious and unexpected X B. Any new information received from the sponsor C. All of the above 21 CFR Part 56.108 IRB functions and operations. In order to fulfill requirements of these regulations, each IRB shall: (b)Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1)Any unanticipated problems involving risks to human subjects or others; (2)any instance of serious or continuing non-compliance with these regulations or the requirements or determinations of the IRB; (3)any suspension or termination of IRB approval.

Which of the below is not required to be named on the FDA Form 1572?

A. Clinical laboratory being to be used in the study B. IRB responsible for review and approval C. Study coordinator X B. Institution where the investigation will be conducted 21 CFR Part 312.53 Selecting investigators and monitors. (c)Obtaining information from the investigator. Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following: (1)A signed investigator statement (Form FDA-1572) containing: (i)The name and address of the investigator; (iii)The name and address of any medical school, hospital, or other research facility where the clinical investigation(s) will be conducted; (iv)The name and address of any clinical laboratory facilities to be used in the study; (v)The name and address of the IRB responsible for review and approval of the study(ies); (viii)A list of the names of the subinvestigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s).

Clinical Hold's can occur in Phase I Trials if:

A. Comparable or satisfactory drug / therapy becomes available to treat that stage of disease and/or that intended population B. Sponsor is not pursuing marketing approval with due diligence B. IND does not properly assess risks X C. All of the above 21 CFR Part 312.42 Clinical holds and requests for modification. (b)Grounds for imposition of clinical hold-(1)Clinical hold of a Phase 1 study under an IND. FDA may place a proposed or ongoing Phase 1 investigation on clinical hold if it finds that: (iv)The IND does not contain sufficient information required under 312.23 to assess the risks to subjects of the proposed clinical studies.

The informed consent regulations in 21 CFR 50 apply to ____.

A. Drugs B. Medical devices C. Biological products D. All of the above X 21 CFR Part 50 Protection of Human Subjects 50.1 Scope. (a)This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products.

Phase I Trials typically

A. Evaluate overall risk/benefit B. Are designed to determine metabolic & pharmacologic actions of a drug in people and side effects of increasing doses X C. Evaluate the effectiveness of a drug for a particular indication D. All of the above 21CFR Part 312.21 Phases of an investigation. (a)Phase 1. (1)Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80.

Which of the elements below is a required component(s) of Informed Consent?

A. Financial compensation to subject B. # of participants in the study C. Description of risks/discomforts subject may experience & who to contact in the case of emergency D. All of the above 21 CFR Part 50.25) Elements of informed consent. (2) A description of any reasonably foreseeable risks or discomforts to the subjects. (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

Records of the product's delivery to the trial site, inventory at the trial site, the use by the trial subject, and the return to the sponsor or alternate disposition of unused product(s), should be maintained by the _____.

A. IRB B. Investigator X C. Sponsor ICH Guidelines. Guideline for Good Clinical Practice. 4.6 Investigational Product(s). 4.6.3 The investigator/institution and/or pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s).

Who determines if an IRB or Institution has to compensate subjects if injury occurs as a result of participation in a clinical study?

A. IRB B. Sponsor B. Institution X

Individual Subjects' Informed Consents are retained by _____ .

A. IRB B. Sponsor B. Site X 21 CFR Part 312.62 Investigator recordkeeping and record retention. (b)Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records, including, for example, progress notes of the physician , the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

Subjects' Identification Code Lists and Enrollment Logs are retained by _____.

A. IRB B. Sponsor B. Site X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.4 After Completion or Termination of the Trial. After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the following: 8.4.3. Completed subject identification code list to permit identification of all subjects enrolled in a trial in case follow-up is required. List should be kept in a confidential manner and for agreed upon time in the files of the investigator/institution.

The Investigator's Final Report is retained by _____ and is sent to the reviewing IRB and/or designated Regulatory Authorities.

A. IRB B. Sponsor C. Site X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.4 After Completion or Termination of the Trial. After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the following: 8.4.7. Final report by investigator/institution to IRB/IEC where required, and where applicable, to the regulatory authority(ies) (see section 4.13) to document completion of the trial are located in the files of the investigator/institution.

Treatment allocation and Decoding Documentation is retained by _____ after the Final Closeout Visit is completed.

A. IRB B. Sponsor X B. Site ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8.4.6 Treatment allocation and decoding documentation. Returned to sponsor to document any decoding that may have occurred.

Audit Certificates are retained by _____.

A. IRB B. Sponsor X C. Site ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.19 Audit. 5.19.3 Auditing Procedures. (e)Where required by law or regulation, the sponsor should provide an audit certificate.

Trial master files should be kept at the ____'s office.

A. IRB & FDA B. Sponsor & Investigator X B. FDA & Sponsor ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.1 Introduction. Trial master files should be established at the beginning of the trial, both at the investigator/institution's site and at the sponsor's office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.

Which of the following would be an example of a Serious Adverse Drug Experience?

A. In patient hospitalization B. A significant or persistent disability C. All of the above X 21 CFR Part 312.32 IND safety reports. Serious adverse drug experience: Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life threatening adverse drug experience, impatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Phase III Trials typically:

A. Include expanded and controlled trials X B. Determine common short term side effects and risks C. Are conducted on patients or normal volunteers D. All of the above 21 CFR Part 312.21 Phases of an investigation. ©Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.

Who must maintain copies of the audit certificate, if required, and the final trial closeout monitoring report?

A. Investigator B. CRO C. Sponsor X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.4 After Completion or Termination of the Trial. 8.4.4. The audit certificate's (if required) purpose is to document that the audit was performed (see section 5.19.3(e)) and is located in the files of the sponsor.

Any trial related duties not specifically transferred to and assumed by a CRO are retained by the _____.

A. Investigator B. Sponsor X C. IRB 21 CFR Part 312.52 Transfer of obligations to a contract research organization. (a)A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Any obligation not covered by the written description shall be deemed not to have been transferred.

Monitors should be appointed by the _____.

A. Investigator B. Sponsor X C. IRB 21 CFR Part 312.53 Selecting investigators and monitors. (d)Selecting monitors. A sponsor shall select a monitor qualified by training and experience to monitor the progress of the investigation.

Who is responsible for ensuring that the IRB has the most current investigator's brochure?

A. Investigator X B. Sponsor C. CRO ICH Guidelines. Guideline for Good Clinical Practice (GCP). 7. Investigator's Brochure. 7.1 Introduction. Generally the sponsor is responsible for ensuring that an up-to-date IB is made available to the investigator(s) and the investigator(s) are responsible for providing the up-to-date IB to responsible IRBs/IECs.

Charging $ for IND's under an IND Application is not allowed, unless:

A. Investigator submits a need to charge & receives written approval from the FDA ~A. IRB mandates in informed consent & receives written approval from the FDA B. Sponsor submits an explanation of the need to charge & receives written approval from the FDA X 21 CFR Part 312.7 Promotion and charging for investigational drugs. (d)Charging for and commercialization of investigational drugs - (1)Clinical trials under an IND. Charging for an investigational drug ina clinical trial under an IND is not permitted without prior written approval of FDA. In requesting such approval, the sponsor shall provide a full written explanation of why charging is necessary in order for the sponsor to undertake or continue the clinical trial, e.g., why distribution of the drug to test subjects should not be considered part of the normal cost of doing business.

Phase II and III grounds for a Clinical Hold include:

A. Investigators named in IND are not qualified B. Protocol design is deficient to support stated objectives X C. None of the above 21 CFR Part 312.42 Clinical holds and requests for modification. (b)Grounds for imposition of clinical hold-(2)Clinical hold of a Phase 2 or 3 study under an IND. FDA may place a proposed or ongoing Phase 2 or 3 investigation on clinical hold if it finds that: (ii)The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.

Which of these verifications must a monitor perform during a monitoring visit?

A. Missing visits or examinations are documented B. Reasons are reported for any subject who failed to complete the study C. No data is missing D. All of the above X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (k) Verifying that source data/documents and other trial records are accurate, complete, kept up-to-date, and maintained. (m) Checking the accuracy and completeness of the CRF entries, source data/documents, and other trial related records against each other. The monitor specifically should verify that: (iv)Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs. (v)All withdrawls and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.

It is _____'s responsibility to report the Subject Recruitment Rate.

A. Monitor X B. Sponsor IRB ICH Guidelines. Guideline for Good Clinical Practice (GCP) 5.18 Monitoring. 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (j)Reporting the subject recruitment rate.

What information must an investigator provide to a sponsor to confirm IRB or IEC review?

A. Name/address of the investigator-institution's IRB or IEC B. Statement from the IRB or IEC that it operates in accordance with GCP and adheres to applicable laws and regulations C. Documented IRB or IEC approval or favorable opinion D. All of the above X FDA Information Sheet Guidances. Sponsor-Investigator-IRB Relationship. Sponsor Assurance that IRBs Operate in Compliance with 21 CFR Part 56. Sponsors should rely on the clinical investigator, who assures the sponsor on form FDA-1572 for drugs and biologics or the investigator agreement for devices that the study will be reviewed by an IRB. An IRB must notify an investigator in writing of its decision to approve, disapprove or request modifications in a proposed research activity ( 21 CFR 56.109(e)). This correspondence should be made available to the sponsor by the clinical investigator. In the Agency's view, this required documentation provides the sponsor with reasonable assurance that an IRB complies with 21 CFR Part 56 and that it will be responsible for initial and continuing review of the study.

The alternative study design generally proposed to the above kind of studies is _____ in which a finding of no difference between the test article and the recognized effective agent would be considered evidence of effectiveness of the new agent, and are typically used in antibiotic trials, for example.

A. Placebo concurrent control B. Active treatment control X C. Historical control FDA Information Sheet Guidances. Drug Study Designs. FDA regulations ( 21 CFR Part 312.126) cite five different kinds of controls that can be useful in particular circumstances: Placebo control, no-treatment control (suitable where objective measurements are felt to make blinding unnecessary), and dose-comparison control studies are all study designs in which a difference is intended to be shown between the test article and some control. The alternative study design generally proposed to these kinds of studies is an active treatment concurrent control in which a finding of no difference between the test article and the recognized effective agent (active-control) would be considered evidence of effectiveness of the new agent.

What action or actions must the investigator or institution take if a study is terminated prematurely or suspended prior to completion?

A. Promptly inform all subjects B. Make arrangements for appropriate therapy and follow up activities C. Inform regulatory authorities, if applicable D. All of the above X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.12 Premature Termination or Suspension of a Trial. If the trial is terminated prematurely or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority(ies).

____ refers to documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data, as well as assist in trial management, serve as an audit base, and confirm the integrity of collected data.

A. Source documents B. CRF's C. Essential documents X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.1 Introduction. Essential documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, the sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. Essential documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor, and monitor. These documents are also the ones that are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of the data collected.

Where allowed/required, the ______ may/should assign some or all of the investigator's/institution's duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution.

A. Sponsor B. IRB C. Investigator/Institution X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.6 Investigational Product(s). 4.6.2 Where allowed/required, the investigator/institution may/should assign some or all of the investigator's/institution's duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution.

During the clinical trial, the Signature Sheet should be located in the files of the _____ .

A. Sponsor B. Investigator/Institution C. Both X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.3. During the Clinical Conduct of the Trial. The following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. 8.3.24 Signature sheet to document signatures and initials of all persons authorized to make entries and/or corrections on CRFs are located in the files of both the investigator/institution and the sponsor.

The Final Report by the investigator/institution to the IRB/IEC where required, and where applicable, to the regulatory authorities should be located in the files of the _____. Duplicate question to one above

A. Sponsor B. Investigator/Institution X C. Both ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.4 After Completion or Termination of the Trial. After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the following: 8.4.7. Final report by investigator/institution to IRB/IEC where required, and where applicable, to the regulatory authority(ies) (see section 4.13) to document completion of the trial are located in the files of the investigator/institution.

Any changes made to CRF's should be endorsed by the _____.

A. Sponsor B. Monitor C. Investigator X ICH Guidelines. Guideline for Good Clinical Practice. 5.18.4 Monitor's Responsibilities. (n)The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialed by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented.

An investigator may dispose of an investigational drug only under written authorization from the ____ and must also ensure that the disposition method will not expose humans to risks from the drug.

A. Sponsor X B. IRB C. FDA 21 CFR Part 312.59 Disposition of unused supply of investigational new drug. The sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated. The sponsor may authorize disposition of unused supplies of the investigational drug provided this alternative disposition does not expose humans to risks from the drug. The sponsor shall maintain written records of any disposition of the drug in accordance with 312.57.

Original Signed, dated, and completed case report forms should be held by _____. Copies of signed, dated, and completed case report forms should be held by _____.

A. Sponsor, Investigator/Institution X B. Investigator/Institution, Sponsor ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.3 During the Conduct of a Clinical Trial. The following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. 8.3.14. Signed, dated, and completed case report forms (CRFs) to document that the investigator or authorized member of the investigator's staff confirms the observations recorded are located in the files of the investigator/institution (copy) and the sponsor (original).

Minor changes to the protocol and/or consent form during the study may be implemented by investigators, provided which of the following is informed properly?

A. The IRB B. None of these. Investigators may not implement protocol or informed consent changes without prior approval of the sponsor and IRB except when necessary to protect the rights and welfare of study subjects, after which immediate notification is required. X C. The sponsor and the local institution D. The sponsor and the FDA 21 CFR Part 50.23 Exceptions from general requirements. (b)If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the test article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. (c)The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.

Who is responsible for ensuring that accurate and complete records are kept of subject participation in a clinical study?

A. The investigator and monitor X B. The sponsor and monitor C. The IRB and investigator

The FDA's informed consent regulations include detailed criteria for the consent process for research conducted in emergency situations. Which of the following statement or statements reflect these criteria?

A. The investigator must provide public disclosure of the research in the local community B. An unconscious subject may be enrolled without informed consent, provided the investigator attempts to contact the next of kin, in accordance with the protocol and IRB/IEC approval conditions C. The sponsor is required to file a separate IND for research D. All of the above X 21 CFR Part 50.24 Exception from informed consent requirements for emergency research. (7)Additional protections of the rights and welfare of the subjects will be provided, including, at least: (ii)Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits; (iii)Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results; (v)If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of the continuing review. (d)Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments under 312.30 or 812.35 of this chapter.

Which of the elements below are necessary for signed electronic records?

A. The printed name of the signer B. The date/time when the signature was executed C. The meaning of the signature (such as review, approval, authorship) D. All of the above X 21 CFR Part 11.50 Signature manifestions. (a)Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1)The printed name of the signer; (2)The date and time when the signature was executed; and (3)The meaning (such as review, approval, responsibility, authorship) associated with the signature.

New Safety Information is reported to Investigators and IRB's by updating the Investigator's Brochure.

A. True B. False 21 CFR Part 312.55 Informing Investigators. (b)The sponsor shall, as the overall investigation proceeds, keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised investigator brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with 312.32.

Following collection of CRF's by the sponsor, investigators are not required to endorse changes made to CRF's by the sponsor.

A. True B. False X

For all drugs studied under the FDA's IND regulations, all laboratory values that are greater than twice the limit of the normal range are required to be reported as adverse events.

A. True B. False X

GCP does not require monitors to evaluate original medical records that have been prepared on paper, provided the investigator provides access to electronically scanned copies of the records.

A. True B. False X

If a clinical investigator receives an honorarium of $2500 from a sponsor for speaking at a meeting that is unrelated to the clinical study, this compensation is required to be disclosed under the FDA's financial disclosure regulations.

A. True B. False X

Research coordinators are always required to be listed on the 1572 as sub-investigators.

A. True B. False X

When a trial includes subjects who can only be enrolled in the trial with the consent of the subject's LAR, it is not necessary for the subject to be informed about the trial.

A. True B. False X

Changes made to electronic records may obscure and delete previous recorded information, so that the most current information will always be accessible.

A. True B. False X 21 CFR Part 11.10 Controls for closed systems. Such procedures and controls shall include the following: (e)Use of secure, computer generated, time stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previous recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

Each electronic signature can only be reused by one other person beyond the originator.

A. True B. False X 21 CFR Part 11.100 General requirements. (a)Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

If an IND is placed on a Clinical Hold for >2 years, the FDA may place all investigations covered by the IND on Inactive Status

A. True B. False X 21 CFR Part 312.45 Inactive status. (a)If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status.

It is possible that the Informed Consent can contain oral or written verbiage that releases the Investigator / Site, Sponsor, or their agents from responsibility from negligence.

A. True B. False X 21 CFR Part 50.20 General requirements for informed consent. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

While a statement of significant new findings which may relate to the subject's willingness to continue participation in the research does not have to be provided to study subjects, it must be provided to the investigator and he or she may then decide whether or not to inform subjects.

A. True B. False X 21 CFR Part 50.25 Elements of informed consent. (b)Additonal elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (5)A statement that significant new findings developed during the course of the research which may relate to a subject's willingness to continue participation will be provided to the subject.

All IRB's are required to have at least 7 members of varying race, gender, and occupation. Additionally, 1 member must be non-scientific in occupation.

A. True B. False X 21 CFR Part 56.107 IRB membership. (a)Each IRB shall have at least 5 members, with carrying backgrounds to promote complete and accurate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects; (c)Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are non-scientific areas.

An IRB must require that informed consent documents comply with the required elements of informed consent, but cannot require any additional criteria.

A. True B. False X 21 CFR Part 56.109 IRB review of research. (b)An IRB shall require that information given to subjects as part of informed consent is in accordance with 50.25. The IRB may require that information, in addition to that specifically mentioned in 50.25, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

If a witness is required for informed consent, he/she must witness the signature of the study subject, but need not be present for all the discussions between the person obtaining consent and the subject.

A. True B. False X 50.27 Documentation of informed consent. (b)Except as provided in 56.109(c), the consent form may be either of the following: (2)A short form written consent document stating that the elements of informed consent required by 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Per FDA Regulations, when a subject withdraws from a study, the data collected on that subject to the point of withdrawal does not remain a part of the study database and can be removed.

A. True B. False X FDA Information Sheet Guidances. Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials. II. Background. FDA laws and regulations require the collection and maintenance of complete clinical study data. This includes information on subjects who withdraw from a clinical investigation, whether the subject decides to discontinue participation in the clinical trial (21CFR 50.25 (a)(8)) or is discontinued by the investigator because the subject no longer qualifies under the protocol (for example, due to a significant adverse event or due to failure to cooperate with study requirements). FDA recognizes that a subject may withdraw from a study; however, the withdrawal does not extend to the data already obtained during the time the subject was enrolled. FDA's longstanding policy has been that all data collected up to the point of withdrawal must be maintained in the database and included in subsequent analyses, as appropriate.

Informed Consent must be administered by the Principal Investigator.

A. True B. False X FDA Information Sheets. A Guide to Informed Consent. The Consent Process. FDA does not require the investigator to personally conduct the consent interview. The investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research...The IRB should be aware of who will conduct the consent interview.

FDA regulation requires all data on a case report form to be duplicated in another document, most often known as a source document.

A. True B. False X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. (m)Checking the accuracy and completeness of the CRF entries, source data/documents, and other trial related records against each other. The monitor specifically should verify that: (i)The data required by the protocol are reported accurately on the CRFs and are consistent with the source data/documents.

It is solely the Sponsor's responsibility to ensure that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirements.

A. True B. False X ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (f) Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s).

A mentally competent adult subject is legally able to give his or her own informed consent to participate in a clinical trial without the presence of a witness.

A. True X B. False

When an individual executes one or more signings not performed during a single continuous period of controlled system access, each signing shall be executed using all of the electronic signature components (i.e. password & identification code).

A. True X B. False 21 CFR Part 11.200 Electronic signature components and controls. (a)Electronic signatures that are not based upon biometrics shall: (1)Employ at least two distinct identification components such as an identification code and password. (ii)When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

Except for emergency situations, the Investigator should not implement any changes in the protocol without sponsor and IRB review/approval.

A. True X B. False 21 CFR Part 312.30 Protocol amendments. (2)(i) A protocol change under paragraph (b)(1) of this section may be made provided two conditions are met: (a)The sponsor has submitted the change to FDA for its review; and (b)The change has been approved by the IRB with responsibility for review and approval of the study. The sponsor may comply with these two conditions in either order. (ii)Not withstanding paragraph (b)(2)(i) of this section, a protocol change intended to eliminate an apparent immediate hazard to subjects may be implemented immediately provided FDA is subsequently notified by protocol amendment and the reviewing IRB is notified in accordance with 21 CFR Part 56.104(c).

An unexpected adverse drug experience is one which is not consistent with the current Investigator Brochure.

A. True X B. False 21 CFR Part 312.32 IND safety reports. Unexpected adverse drug experience: Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.

If no subjects are enrolled under an IND for >2 years, the FDA may place all investigations covered under an IND on Inactive Status.

A. True X B. False 21 CFR Part 312.45 Inactive status. (a)If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status. 21 CFR Part 312.45 Inactive status. (a)If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status.

When a sponsor transfers some or all of its obligations to a CRO, the CRO is required to comply with all regulations designated as sponsor requirements for the transferred obligations.

A. True X B. False 21 CFR Part 312.52 Transfer of obligations to a contract research organization. (b)A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to "sponsor" in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor.

An IND drug label should read: "Caution: New Drug-Limited by Federal (or US) Law to Investigational Use".

A. True X B. False 21 CFR Part 312.6 Labeling of an investigational new drug. (a)The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use."

The Sponsor nor Investigator will commercially distribute or test market an IND.

A. True X B. False 21 CFR Part 312.6 Labeling of an investigational new drug. (b)Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug.

The records referenced above should include batch #'s, dates, quantities, expiration dates, and the unique code assigned to the investigational product and trial subject.

A. True X B. False 21 CFR Part 312.62 Investigator recordkeeping and record retention. (a)Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.

The purpose of randomization in a clinical trial is to reduced bias in a study by incorporating an element of chance to determine treatment assignment.

A. True X B. False 21 CFR Part 314.126 Adequate and well-controlled studies. (b)An adequate and well-controlled study has the following characteristics: (4)The method of assigning patients to treatment and control groups minimizes bias and is intended to assure comparability of the groups with respect to pertinent variables such as age, sex, severity of disease, duration of disease, and the use of drugs or therapy other than the test drug. The protocol for the study and the report of its results should describe how subjects were assigned to groups. Ordinarily, in a concurrently controlled study, assignment is by randomization, with or without stratification.

A subject may discontinue participation in a study at any time without sacrificing penalty or loss of benefits to which the subject is otherwise entitled.

A. True X B. False 21 CFR Part 50.25 Elements of informed consent. (a)Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject: (8)A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Even though a child may assent, permission of each child's parent(s) or guardian(s) is required prior to enrolling children into research studies, unless a special exception applies.

A. True X B. False 21 CFR Part 50.55 Requirements for permission by parents or guardians and for assent by children. (a)In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting assent of the children when in the judgment of the IRB the children are capable of providing assent. (e)In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that the permission of each child's parents or guardians is granted.

The applicant who submits a marketing application to FDA for approval of a drug, device, or biologic product, must also disclose the financial interests of a clinical investigator who is not full time or part time employee of the sponsor for each covered clinical study.

A. True X B. False 21 CFR Part 54.4 Certification and disclosure requirements. The applicant must also completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is not a full-time or part-time employee of the sponsor for each covered clinical study.

All IRB's must have Written Procedures for reporting, non-compliance, suspension/termination of approval.

A. True X B. False 21 CFR Part 56.108 IRB Functions and operations. In order to fulfill the requirements of these regulations, each IRB shall: (a)Follow written procedures; (1)For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (b)Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1)Any unanticipated problems involving risks to human subjects or others; (2)any instance of serious or continuing non-compliance with these regulations or the requirements or determinations of the IRB; (3)any suspension or termination of IRB approval.

Informed Consents do not have to be witnessed by a 3rd party, unless the potential subject is illiterate.

A. True X B. False 50.27 Documentation of informed consent. (b)Except as provided in 56.109(c), the consent form may be either of the following: (2)A short form written consent document stating that the elements of informed consent required by 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Obtaining oral informed consent using a short form always requires a witness.

A. True X B. False 50.27 Documentation of informed consent. (b)Except as provided in 56.109(c), the consent form may be either of the following: (2)A short form written consent document stating that the elements of informed consent required by 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Clinical Trial Advertisements must be included in the initial IND Application and be approved by the reviewing IRB.

A. True X B. False ICH Guidelines (GCP) Part 4.4 Communication with IRB/IEC 4.4.1 Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.

The investigator should maintain a log of delegated trial related duties to sub or co-investigators and other qualified persons.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.1.5 Investigator's Qualifications and Agreements. The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

If a subject enrolled in an out-patient arthritis study is admitted to a hospital for overnight observation due to injuries suffered in an automobile accident, it would be considered as a serious adverse event according to the FDA's regulations.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.11 Safety Reporting. 4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed up promptly by detailed, written reports.

Although a subject is not required to give an Investigator a reason for early withdrawal from a study, it is recommended that the Investigator make an effort to try to ascertain the reason(s), while respecting the subject's rights.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.3.4 Medical Care of Trial Subjects. Although a subject is not obliged to give his /her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.

It is the Monitor's responsibility to ensure the accuracy and completeness of the CRF entries, source data documents, and other trial related records against each other.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (m) Checking the accuracy and completeness of the CRF entries, source data/documents, and other trial related records against each other. The monitor specifically should verify that: (i)The data required by the protocol are reported accurately on the CRFs and are consistent with the source data/documents. (ii)Any dose and/or therapy modifications are well documented for each of the trial subjects. (iii)Adverse events, concomitant medications, and intercurrent illnesses are reported in accordance with the protocol on the CRFs. (iv)Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs. (v)All withdrawls and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.

When a formal investigator's brochure is impractical, providing an expanded background information section in the trial protocol that contains the minimum current information described in the guideline is acceptable.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 7. Investigator's Brochure. 7.1 Introduction. In cases where preparation of a formal IB is impractical, the sponsor-investigator should provide, as a substitute, an expanded background information section in the trial protocol that contains the minimum current information described in this guidance.

GCP requires the maintenance of some type of evidence documenting the credentials of all clinical laboratories used to evaluate specimens during a clinical trial.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.2 Before the Clinical Phase of the Trial Commences. During this planning stage the following documents should be generated and should be on file before the trial formally starts. 8.2.12. Medical/laboratory/technical procedures/tests certification or accreditation or established quality control and/or external quality assessment or other validation (where required) to document competence of facility to perform required test(s), and support reliability of results are located in the files of the investigator/institution (where required) and the sponsor.

A telephone log of discussions with sponsor personnel for study-related issues should be maintained by study coordinators as part of the permanent study records and may be considered a source document.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.3. During the Clinical Conduct of the Trial. The following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. 8.3.11. Relevant communications other than site visits (letters, meeting notes, notes of telephone calls) to document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting are located in the files of the investigator/institution and the sponsor.

A telephone log of discussions with sponsor personnel for study-related issues should be maintained by study coordinators as part of the permanent study records and may be considered a source document. Duplicate of #76?

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 8. Essential Documents for the Conduct of a Clinical Trial. 8.3. During the Clinical Conduct of the Trial. The following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. 8.3.11. Relevant communications other than site visits (letters, meeting notes, notes of telephone calls) to document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting are located in the files of the investigator/institution and the sponsor.

Serious Adverse Events not related to the study drug should not undergo Expedited Reporting.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice. 5.17 Adverse Drug Reaction Reporting. 5.17.1 The sponsor should expedite the reporting to all concerned investigator(s)/institution(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected.

Sponsor and/or Investigator records custody responsibility can be transferred to a 3rd party and notice of the transfer must be sent to the FDA within 10 working days.

A. True X B. False ICH Guidelines. Guidelines for Good Clinical Practice. 5.5 Trial Management, Data Handling, Recordkeeping, and Independent Data Monitoring Committee. 5.510 Any transfer of ownership of the data should be reported to the appropriate authority(ies), as required by applicable regulatory requirement(s).

It is the Monitor's responsibility to verify that the Investigator has adequate qualifications and resources and these remain adequate throughout the trial period, and that staff and facilities, including laboratories and equipment, are adequate to safely and properly conduct the trial and these remain adequate throughout the trial period.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (b)Verifying that the investigator has adequate qualifications and resources and these remain adequate throughout the trial period, and that the staff and facilities, including laboratories and equipment, are adequate to safely and properly conduct the trial and these remain adequate throughout the trial period.

Monitors are required by GCP in inform investigators of observed deficiencies during the monitoring process and define the actions necessary by the investigator to correct the observed deficiencies.

A. True X B. False ICH Guidelines. Guideline for Good Clinical Practice (GCP). 5.18.4 Monitor's Responsibilities. The monitor(s), in accordance with the sponsor's requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (q)Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

It is possible for an Institution to have its own internal IRB.

A. True X B False FDA Information Sheets. Frequently Asked Questions. I.IRB Organization. 6.Must an institution establish its own IRB? No. Although institutions engaged in research involving human subjects will usually have their own IRBs to oversee research conducted within the institution or by the staff of the institution, FDA regulations permit an institution without an IRB to arrange for an outside IRB to be responsible for initial and continuing review of studies conducted at the non-IRB institution.

When does the ICH GCP guideline require an impartial witness to be present for the consent process?

A. When the subject cannot read X B. A witness is always required C. When the subject is mentally disabled ICH Guidelines. Guideline for Good Clinical Practice (GCP). 4.8 Informed Consent of Trial Subjects. 4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion.

If an IRB has any changes in their contact information, notice must be sent to the FDA:

A. Within 90 days X B. When they renew C. Within 30 days 21 CFR Part 56.106 Registration. (e)If an IRB's contact or chair person information changes, the IRB must revise its registration information by submitting any changes in that information within 90 days of the change.

Are IND's submitted by the Sponsor to the FDA required to include a sample informed consent document?

A. Yes B. No X 21 CFR Part 312.23 IND content and format. (a)A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including, in the following order: (1)Cover Sheet (Form FDA-1571). (2)A table of contents. (3)Introductory statement and general investigational plan. (4)[Reserved]. (5)Investigator's brochure. (6)Protocols. (7)Chemistry, manufacturing, and control information. (8)Pharmacological and toxicology information. (9)Previous human experience with the investigational drug. (10)Additonal information. (11)Relevant information.