SOCRA Certified Clinical Research Professional CCRP Exam Questions

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Total 130 questions
Question 1

A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?



Answer : C

21 CFR 54.2(f) & 54.4(a): Requires disclosure of ''significant payments of other sorts'' (SPOOS) that exceed $25,000 or equity interests exceeding $50,000.

However, honoraria or consulting exceeding $10,000 annually also trigger disclosure.

Thus, the reporting threshold is $10,000.


Question 2

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



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 3

During the closeout visit, a monitor is completing the documentation of reconciliation of investigational product. All packaging, as well as the used and unused investigational product, are being returned to the sponsor for disposition. Which of the following documents would NOT be required to be filed at the research site?



Answer : D

Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).

ICH E6(R2) 4.6.3: Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.

ICH E6(R2) 8.2.14--8.2.16: Essential documents include shipment records, accountability logs, and inventory records.

However, certificates of destruction are generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.

Thus, the correct answer is D (Certificate of destruction).


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

ICH E6(R2), 8.2.14--8.2.16 (Essential documents).

Question 4

According to 21 CFR Part 11, each electronic signature must be unique and:



Answer : D

21 CFR 11.100(a): Requires that electronic signatures be ''unique to one individual and shall not be reused or reassigned to anyone else.''

This ensures accountability and audit trail integrity.


Question 5

Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?



Answer : D

For non--sponsor investigators, responsibilities are limited to site-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 to sponsors:

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).


ICH E6(R2), 4.6.1.

21 CFR 312.61.

Question 6

A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?



Answer : C

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3: ''The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).''

ICH E6(R2) 4.6.4: ''The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.''

During site qualification/selection, the monitor evaluates storage conditions --- particularly temperature ranges --- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer is C (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.


ICH E6(R2), 5.13.3 (Product storage requirements).

ICH E6(R2), 4.6.4 (Investigator product storage responsibilities).

Question 7

Which of the following is considered a source document?



Answer : D

Source documents are the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.

ICH E6(R2) 1.52: Defines source documents as ''original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, recorded data from automated instruments, etc.).''

ICH E6(R2) 8.3.13: Requires maintenance of ''source documents'' to verify data integrity and allow monitoring/audits.

Pharmacy dispensing records (D) fit this definition, as they show initial data on investigational product dispensing and accountability. In contrast, subject instruction sheets (A) are communication tools, SOPs (B) are procedural guides, and the protocol (C) is a governing document, none of which qualify as original data records.

Therefore, the correct answer is D (Pharmacy dispensing records).


ICH E6(R2), 1.52 (Definition of source documents).

ICH E6(R2), 8.3.13 (Source documents in essential documentation).

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Total 130 questions