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SOCRA CCRP Exam
Certified Clinical Research Professional (Page 4 )

Updated On: 7-Feb-2026
Page 4 of 27
PDF with 130 Questions

In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB/IEC will conduct the initial and continuing review of a study?

  1. The sponsor
  2. The monitor
  3. The investigator
  4. The study coordinator

Answer(s): C

Explanation:

The investigator is directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.

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 for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects."

21 CFR 312.66: "An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study."

This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approval at their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.

Thus, the correct answer is C (The investigator).


Reference:

ICH E6(R2), §4.4.1 (Investigator responsibility before initiation).

21 CFR 312.66 (IRB responsibility in clinical investigations).



In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:

  1. 2 years
  2. 3 years
  3. 5 years
  4. 15 years

Answer(s): A

Explanation:

The FDA record retention requirement for investigational drug studies is clearly outlined in 21 CFR 312.57(c) and 21 CFR 312.62(c).

21 CFR 312.57(c): "A sponsor shall retain the records and reports... for 2 years after a marketing application is approved for 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 for 2 years following the date a marketing application is approved or 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 is A (2 years).


Reference:

21 CFR 312.57(c) (Sponsor record retention).

21 CFR 312.62(c) (Investigator record retention).



Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

  1. The Department of Health and Human Services
  2. The FDA or another regulatory authority
  3. The IRB/IEC
  4. No approvals are necessary if no pharmaceutical drugs are involved

Answer(s): C

Explanation:

Even if a study does not involve drugs, devices, or biologics, it still involves human subjects and therefore requires ethical review by an IRB/IEC.

45 CFR 46.109(a): "An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."

ICH E6(R2) 3.1.2: "The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects."

Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.

Thus, the correct answer is C (The IRB/IEC).


Reference:

45 CFR 46.109(a) (IRB review of research).

ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).



A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines,

which of the following documents should the clinical investigator maintain?

  1. The master randomization list
  2. The completed subject identification code list
  3. The final trial closeout monitoring report
  4. The audit certificate

Answer(s): B

Explanation:

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. The Subject Identification Code List is a key essential document for ensuring traceability while maintaining confidentiality.

ICH E6(R2) 8.3.21: "Subject Identification Code List -- A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."

ICH E6(R2) 8.4: Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.

Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. The subject code list ensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

Thus, the correct answer is B (Completed Subject Identification Code List).


Reference:

ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).

ICH E6(R2), §8.4 (Essential documents for trial closure).



A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub- investigator needs to break the blind.
Where can the sub-investigator find a description of the unblinding procedure?

  1. The informed consent form
  2. The Investigator's Brochure
  3. The study protocol
  4. The case report form

Answer(s): C

Explanation:

Unblinding procedures are a protocol-level responsibility because they involve trial design, safety management, and subject protection.

ICH E6(R2) 6.0 (Protocol and amendments): Requires the protocol to specify "the treatment(s) and treatment periods, procedures for randomization and blinding, and procedures for breaking codes."

ICH E6(R2) 4.7: "The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol."

The informed consent (A) explains risks and rights but does not include operational unblinding procedures. The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.

Therefore, the correct answer is C (The study protocol), as it outlines unblinding steps and documentation requirements.


Reference:

ICH E6(R2), §6.0 (Protocol content).

ICH E6(R2), §4.7 (Randomization and unblinding).



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