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According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?
Answer : A
The short form consent process is permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.
21 CFR 50.27(b)(2): Requires the short form to be signed by the subject (or legally authorized representative) and a witness.
The witness ensures that oral consent was properly conveyed and understood.
The person obtaining consent must sign a separate written summary, but not the short form itself.
Thus, the accurate answer is A: subject (or LAR) + witness.
21 CFR 50.27(b)(2).
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
Answer : C
21 CFR 312.56(d): If an IND is withdrawn for safety, the sponsor must notify FDA and all participating investigators, who in turn notify IRBs.
Ensures subjects are protected and sites stop enrollment.
In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study. Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?
Answer : D
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.''
Sponsors must confirm IRB approval before authorizing initiation.
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?
Answer : C
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.
ICH E6(R2), 4.6 (Investigational Product(s)).
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
Answer : B
An Independent 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 an independent 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/IDMCs do not perform trial approvals (A), do not design trials (C), and do 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 is B (Recommendations to stop a trial).
ICH E6(R2), 5.5.1 (Independent Data Monitoring Committees).
