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SOCRA Certified Clinical Research Professional CCRP Exam

Attempt the SOCRA CCRP Certification practice test and solve real exam-like CCRP questions to prepare efficiently and increase your chances of success. Our SOCRA CCRP practice questions match the actual Certified Clinical Research Professional exam format, helping you enhance confidence and improve performance. With our CCRP practice exam software, you can analyze your performance, identify weak areas, and work on them effectively to boost your final SOCRA CCRP Certification exam score.

Vendor:	SOCRA
Exam Name:	Certified Clinical Research Professional
Registration Code:	CCRP
Related Certification:	SOCRA CCRP Certification
Exam Audience:	Clinical Research Coordinators, Clinical Research Associates,

Total Questions

130

Last Updated

14-08-2026

Exam Duration

165 MINUTES

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Question: 1

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:

ASuspend all trial-related activities until the events of the deviation have been mitigated

BDocument and explain the deviation from the protocol

CAssign another investigator to perform sample collections until an internal investigation is completed

DImmediately report the observation to the regulatory authority

Answer: B

Explanation:

ICH directs investigators to document and explain any 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 deviation from 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).

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).

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Question: 2

In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?

AAt least 3 years

BAt least 15 years

CUntil the regulatory authority has approved the investigational product for use

DIndefinitely

Answer: A

Explanation:

IRBs/IECs must retain records to permit evaluation of compliance.

ICH E6(R2) 3.4.2: ''IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least 3 years after completion of the trial.''

Extended retention (B--D) may occur institutionally, but ICH minimum is 3 years.

Correct answer: A (At least 3 years).

ICH E6(R2), 3.4.2.

Question: 3

According to ICH GCP, sponsor-specific essential documents must be retained until:

A2 years after last approval and no pending applications

B3 years after last approval

C5 years after last approval

D25 years after last approval

Answer: A

Explanation:

ICH E6(R2) 5.5.12 & 8.1: Essential documents must be retained 2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or 2 years after discontinuation of development.

This ensures availability for inspection.

Question: 4

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

Explanation:

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).

Question: 5

In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

AInstitution

BSponsor

CRegulatory authority

DInvestigator

Answer: B

Explanation:

ICH E6(R2) 5.5.3: Sponsors are responsible for validating computerized systems used in trials.

Investigators ensure proper data entry, but system compliance lies with sponsor.

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