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NEW QUESTION # 29
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?
- A. Report to OHRP
- B. Report to sponsor
- C. None
- D. Report to FDA
Answer: C
Explanation:
* 21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.
* After three years, no disclosure is required.
References:21 CFR 54.4(b).
NEW QUESTION # 30
In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:
- A. Printed, signed, and dated
- B. Managed within a validated computer system
- C. Entered into an electronic case report form
- D. Restricted to authorized clinical trial personnel
Answer: B
Explanation:
21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.
* 21 CFR 11.10(a):Requires "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."
* Validated systems ensure equivalency between electronic and paper records.
While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.
Thus, the correct answer isB (Managed within a validated computer system).
References:
21 CFR 11.10(a) (System validation requirement).
NEW QUESTION # 31
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
- A. 10 days
- B. 1 day
- C. 15 days
- D. 7 days
Answer: D
Explanation:
Serious adverse events are subject to expedited reporting requirements.
* ICH E2A 3.2.2:"Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge."
* ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).
Correct answer:B (7 days).
References:
ICH E2A, §3.2.2.
NEW QUESTION # 32
Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?
- A. 400 mg/m²
- B. 420 mg/m²
- C. 444 mg/m²
- D. 492 mg/m²
Answer: C
Explanation:
370 × 1.20 =444 mg/m².
Accurate dosing calculations are critical for protocol adherence and patient safety.
References:Standard pharmacology dose adjustment principles; ICH E6(R2) §4.5.1.
NEW QUESTION # 33
A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?
- A. The Investigator's Brochure
- B. The data safety monitoring plan
- C. The protocol
- D. The informed consent document
Answer: C
Explanation:
Theprotocolgoverns all trial conduct, including whether subjects should be replaced when they withdraw.
* ICH E6(R2) 6.0:The protocol must contain "detailed information on trial design, methodology, statistical considerations, and the organization of the trial."
* ICH E6(R2) 6.9.2:The section on "Subject withdrawal or discontinuation" specifies "whether and under what conditions subjects may be replaced." Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only theprotocolprovides the operational answer regarding replacement.
Thus, the correct answer isB (The protocol).
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).
NEW QUESTION # 34
During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:
- A. Suspend all trial-related activities until the events of the deviation have been mitigated
- B. Immediately report the observation to the regulatory authority
- C. Assign another investigator to perform sample collections until an internal investigation is completed
- D. Document and explain the deviation from the protocol
Answer: D
Explanation:
ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:
* ICH E6(R2) 4.5.3: "The investigator should document and explain any deviationfrom the approved protocol."
* ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).
References:
ICH E6(R2) Good Clinical Practice, §4.5.3 (Compliance with protocol; deviations).
ICH E6(R2) §3.3.7; §4.5.2 (Reporting deviations implemented to eliminate immediate hazards).
NEW QUESTION # 35
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
- A. Regulatory authority
- B. OHRP
- C. Investigator/institution
- D. DSMB
Answer: C
Explanation:
* ICH E6(R2) 5.6.1:"The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial."This ensures transparency in compensation, reimbursement, and budget.
References:ICH E6(R2) §5.6.1.
NEW QUESTION # 36
In accordance with the CFR, the IRB/IEC membership must have:
- A. At least one cleric
- B. At least seven individuals
- C. A majority of individuals whose primary area of expertise is nonscientific
- D. At least one individual who is not affiliated with the institution
Answer: D
Explanation:
IRBs must be diverse and independent to protect human subjects.
* 21 CFR 56.107(d):"Each IRB shall include at least one member whose primary concerns are in nonscientific areas... andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution." There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.
Thus, the correct answer isD (At least one unaffiliated individual).
References:
21 CFR 56.107(d) (IRB membership requirements).
NEW QUESTION # 37
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?
- A. To discontinue the subject's study drug
- B. To provide the subject with information regarding the significant new findings
- C. To submit this safety update to the regulatory authority
- D. To give the subject's contact information to the sponsor in order to allow the sponsor to contact the subject
Answer: B
Explanation:
Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.
* ICH E6(R2) 4.8.2:"If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner."
* 21 CFR 50.25(b)(5):Consent must include a statement that "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided." Thus, the investigator mustcommunicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer:C.
References:
ICH E6(R2), §4.8.2.
21 CFR 50.25(b)(5).
NEW QUESTION # 38
An approved investigational device exemption (IDE) permits a device to be:
- A. Shipped lawfully for the purpose of conducting a clinical study
- B. Used on a patient who is not enrolled on a clinical study
- C. Sold and marketed for profit
- D. Marketed as a humanitarian device
Answer: A
Explanation:
AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical investigation.
* 21 CFR 812.1(a):"An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply." It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).
Thus, the correct answer isA (Shipped lawfully for clinical study).
References:
21 CFR 812.1(a) (IDE exemption provisions).
NEW QUESTION # 39
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
Explanation:
This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6 (Investigational product management). Subjects must receive the correct supply and any discrepancy must be reconciled.
The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily.
Over 10 days, the subject should consume 40 tablets (4 × 10 = 40). Since 45 tablets were dispensed, the subject should have 5 tablets remaining after 10 days.
Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for maintaining investigational product (IP) records, including dispensing, usage, and returns. According to ICH:
4.6.3: "The investigator/institution should maintain records of the product's delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
4.6.5: "The investigator should ensure that investigational products are used only in accordance with the approved protocol." Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the importance of meticulous IP tracking in clinical trials.
References:
ICH E6(R2), §4.6 (Investigational Product(s)).
NEW QUESTION # 40
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
- A. Investigational pharmacies
- B. Reviewing IRBs/IECs
- C. OHRP
- D. Site coordinator
Answer: B
Explanation:
* 21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.
* Ensures subjects are protected and sites stop enrollment.
References:21 CFR 312.56(d).
NEW QUESTION # 41
For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering. In accordance with the CFR, this effect must be reported to the sponsor and the IRB/IEC as soon as possible and at most how long after the investigator first learns of the effect?
- A. 5 working days
- B. 2 working days
- C. 7 working days
- D. 10 working days
Answer: D
Explanation:
In device trials,unanticipated adverse device effects (UADEs)must be promptly reported.
* 21 CFR 812.150(a)(1):"An investigator shall submit to the sponsor and the reviewing IRB a report of anyunanticipated adverse device effectas soon as possible, but in no event later than10 working days after the investigator first learns of the effect." In this case,severe burns with blisteringgo beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as aUADEand triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a10 working day maximumtimeframe.
Thus, the correct answer isD (10 working days).
References:
21 CFR 812.150(a)(1) (Reporting requirements for investigators).
NEW QUESTION # 42
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
- A. Research pharmacist
- B. Sponsor
- C. OHRP
- D. FDA
Answer: B
Explanation:
* 21 CFR 812.150(a)(1):Investigators must report unanticipated adverse device effects to thesponsor within 10 working days.
* Sponsor is then responsible for notifying FDA and all investigators.
References:21 CFR 812.150(a)(1).
NEW QUESTION # 43
Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?
- A. Death as a result of arrhythmias (irregular heart rhythm), not mentioned in the investigator's brochure and thought to be related to the use of the drug
- B. Death due to disease progression, mentioned in the investigator's brochure
- C. Aplastic anemia requiring hospitalization, mentioned in the investigator's brochure
- D. An infection not related to the investigational drug requiring hospitalization for antibiotic therapy
Answer: A
Explanation:
Sponsors must reportserious, unexpected, and suspected adverse reactions (SUSARs)to the FDA.
* 21 CFR 312.32(c)(2):"Any adverse experience associated with the use of the drug that is bothserious and unexpectedshall be reported...as soon as possible but no later than 7 calendar daysafter the sponsor's initial receipt of the information, if it is fatal or life-threatening."
* ICH E2A 4.2:Requires expedited reporting oflife-threatening or fatal SUSARswithin 7 days.
Among the options, only (C) -death from arrhythmias not previously identified in the Investigator's Brochure and suspected to be drug-related- meets the definition of a SUSAR requiring7-day expedited reporting. Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.
Thus, the correct answer isC.
References:
21 CFR 312.32(c)(2) (Expedited safety reporting).
ICH E2A, §4.2 (Expedited reporting of fatal/life-threatening adverse events).
NEW QUESTION # 44
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
- A. An initial review and approval of a trial
- B. Recommendations to stop a trial
- C. Suggestions for a new trial design
- D. The selection of qualified investigators
Answer: B
Explanation:
AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.
* ICH E6(R2) 5.5.1:"The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial." Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.
Therefore, the correct answer isB (Recommendations to stop a trial).
References:
ICH E6(R2), §5.5.1 (Independent Data Monitoring Committees).
NEW QUESTION # 45
The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission.
According to the ICH GCP Guidelines, which of the following documents should be included in the submission?
- A. Case report forms
- B. Recruitment materials
- C. Local lab normal ranges
- D. The investigators' CVs
Answer: B
Explanation:
IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.
* ICH E6(R2) 3.1.2:The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.
* 21 CFR 56.111(a)(3):Requires equitable subject selection, which extends to advertisements and recruitment.
* FDA Guidance on Recruiting Study Subjects (1998):States that "advertisements and recruitment materials must be reviewed and approved by the IRB prior to use." While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.
Correct answer:C (Recruitment materials).
References:
ICH E6(R2), §3.1.2.
FDA Recruitment Guidance, 1998.
NEW QUESTION # 46
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB
/IEC will conduct the initial and continuing review of a study?
- A. The study coordinator
- B. The investigator
- C. The sponsor
- D. The monitor
Answer: B
Explanation:
Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.
* ICH E6(R2) 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, and any other written information to be provided to subjects."
* 21 CFR 312.66:"An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study." This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.
Thus, the correct answer isC (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibility before initiation).
21 CFR 312.66 (IRB responsibility in clinical investigations).
NEW QUESTION # 47
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
- A. The electronic medical record
- B. A printout of the electronic medical record
- C. A printout of the EDC record
- D. The EDC record
Answer: D
Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51:Defines source data as "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." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).
NEW QUESTION # 48
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