Pass the SOCRA Clinical Research Professional CCRP Questions and answers with ValidTests

The IB must be updatedas new significant safety information emerges.

ICH E6(R2) 7.3:“The sponsor should revise the IB as soon as new, significant information becomes available.”

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).

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.

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer isA (2 years).

For non–sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.

ICH E6(R2) 4.6.1:“Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution.”

21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.

Other responsibilities listed belong tosponsors:

A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).

B: Monitoring at all sites is a sponsor responsibility.

C: Disseminating safety updates is a sponsor’s role.

Correct answer:D (Maintaining control of IP).

Record retention is critical for regulatory inspection and subject protection.

21 CFR 56.115(b):IRBs must retain records forat least 3 yearsafter completion of the research.

ICH E6(R2) 3.4.3:Similarly requires retention of records for a minimum of 3 years after completion.

This allows audits, sponsor inspections, or regulatory reviews long after the study closes. Institutions may require longer retention, but federal minimum is3 years.

Monitoring ensures trial integrity and subject safety.

ICH E6(R2) 5.18.3:“The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.”

Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).

It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it isrisk-adapted and flexible, but must cover all phases of the study.

Correct answer:C (Timely manner before, during, and after).

ICH E6(R2) 5.5.3(g):Requires audit trails for any data changes, recording date, time, and person responsible.This ensures traceability and regulatory compliance.

Other restrictions (B–D) are not mandated under ICH.

ICH E6(R2) 4.2.4:“The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties.”This responsibility cannot be delegated to sponsor or IRB.

ICH E6(R2) 1.52:Source documents are “original documents, data, and records… necessary for the reconstruction and evaluation of the trial.”

Their main role is to document treatment and verify CRFs.

Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and howassentis obtained, in addition to parental permission. Exact extracts:

45 CFR 46.408(a): “The IRB shall determine…whether and to what extent children are capable of providing assent.”

ICH E6(R2) 4.8.12: “Where a subject is unable to give consent personally,assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s).”Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.