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Question 1

After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

AThe investigator

BThe sponsor

CThe study coordinator

DThe IRB/IEC

Answer : B

Monitoring reports are sponsor-controlled documents.

ICH E6(R2) 5.18.6: ''The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report.''

ICH E6(R2) 8.1 & 8.2.22: Monitoring visit reports are essential documents maintained by the sponsor.

Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.

Thus, the correct answer is B (The sponsor).

ICH E6(R2), 5.18.6 (Monitoring reports).

ICH E6(R2), 8.2.22 (Essential documents: monitoring visit reports).

Question 2

An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

ANone

BReport to FDA

CReport to OHRP

DReport to sponsor

Answer : A

21 CFR 54.4(b): Requires disclosure during the study and for 1 year after completion.

After three years, no disclosure is required.

Question 3

An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?

AFDA

BSponsor

CResearch pharmacist

DOHRP

Answer : B

21 CFR 812.150(a)(1): Investigators must report unanticipated adverse device effects to the sponsor within 10 working days.

Sponsor is then responsible for notifying FDA and all investigators.

Question 4

In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

AWritten information to be provided to the subjects

BRequirements for storage of the investigational product

CSponsor's SOPs

DIRB/IEC requirements for reporting to the regulatory authority

Answer : D

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4: Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However, IRB/IEC requirements for reporting to regulatory authorities are outside a monitor's scope. That responsibility lies with investigators and IRBs under 21 CFR 56.108(b).

Thus, the correct answer is D.

ICH E6(R2), 5.18.4.

21 CFR 56.108(b).

Question 5

According to the CFR and ICH GCP, an IRB/IEC must retain all relevant records for how many years after project completion?

AOne year

BTwo years

CThree years

DFour years

Answer : C

Record retention is critical for regulatory inspection and subject protection.

21 CFR 56.115(b): IRBs must retain records for at least 3 years after 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 is 3 years.

Question 6

After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

AThe IRB/IEC

BThe regulatory authority

CThe Data Safety Monitoring Board

DThe sponsor

Answer : D

Audits are part of sponsor quality assurance to ensure trial compliance.

ICH E6(R2) 5.19.3: ''The sponsor's auditing procedures should include the provision of an audit certificate where required.''

ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.

IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.

Correct answer: D.

ICH E6(R2), 5.19.3.

ICH E6(R2), 8.2.20.

Question 7

In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?

AThe Investigator's Brochure

BThe sponsor's written procedures

CThe CRO/site agreements

DThe investigational pharmacy's requirements

Answer : B

Handling of investigational product (IP), including returns, is governed by sponsor's written procedures.

ICH E6(R2) 4.6.3: ''The investigator/institution should maintain records of the product's delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.''

ICH E6(R2) 5.13.3: ''The sponsor should ensure that written procedures include instructions for... the return or alternative disposition of unused product(s).''

The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.

Thus, the correct answer is B (The sponsor's written procedures).

ICH E6(R2), 4.6.3 (Investigator product accountability).

ICH E6(R2), 5.13.3 (Sponsor product return procedures).

SOCRA Certified Clinical Research Professional CCRP Exam Questions