CCRP Exam dumps PDF | Exam-Dumps.net (Page: 2)

QUESTION: 9

In determining the classification of risk for a study involving a medical device, it is necessary to consider the:

Number of patients to be treated with the device
Cost of device
Investigators' prior training and experience
Use of the device in the particular study

Answer(s): D

Explanation:

FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.

21 CFR 812.3(m): Defines a "significant risk device study" as one that "is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject."

Risk is judged within the context of the protocol -- i.e., use of the device in that particular study (D).

Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA's risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.

Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.

Reference:

21 CFR 812.3(m) (Definition of significant risk device).

FDA Guidance on Significant Risk and Nonsignificant Risk Medical Device Studies.

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QUESTION: 10

A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?

The letter documenting the promotion to a CRC
A brochure from the training course
An updated performance review summary
An updated curriculum vitae

Answer(s): D

Explanation:

The regulatory binder (investigator site file) must contain documents verifying qualifications of all personnel. These include curricula vitae (CVs), professional licenses, and training certificates.

ICH E6(R2) 4.1.5: "The investigator should ensure that all persons assisting with the trial are qualified by education, training, and experience... Current curriculum vitae and/or other relevant documents evidencing qualifications should be maintained."

21 CFR 312.53(c)(1): Sponsors must select investigators qualified "by training and experience," and investigators must provide sufficient documentation, typically updated CVs.

Letters of promotion (A), training brochures (B), or performance reviews (C) may remain in personnel files but are not required regulatory documents. The only acceptable regulatory proof is an updated CV (D), which reflects the individual's training and qualifications for their new role.

Therefore, the correct answer is D (Updated CV). This ensures compliance with ICH and FDA requirements for staff qualification documentation in clinical research.

Reference:

ICH E6(R2) Good Clinical Practice, §4.1.5 (Investigator responsibilities for staff qualification).

21 CFR 312.53(c)(1) (Investigator qualifications and documentation).

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QUESTION: 11

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?

The sponsor
The monitor
The investigator
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).

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QUESTION: 12

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

2 years
3 years
5 years
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).

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QUESTION: 13

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?

The Department of Health and Human Services
The FDA or another regulatory authority
The IRB/IEC
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).

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QUESTION: 14

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?

The master randomization list
The completed subject identification code list
The final trial closeout monitoring report
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).

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QUESTION: 15

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?

The informed consent form
The Investigator's Brochure
The study protocol
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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QUESTION: 16

An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?

The investigator/institution and the sponsor
The investigator/institution and the delegated site staff
The sponsor and the IRB/IEC
The sponsor and the FDA

Answer(s): A

Explanation:

The protocol signature page documents agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.

ICH E6(R2) 8.2.2 (Signed protocol and amendments): Requires "the sponsor and investigator/institution to sign the protocol and amendments, confirming agreement."

ICH E6(R2) 4.5.1: "The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC."

The sponsorinvestigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols. These bodies approve or oversee, but do not formally enter into execution of the protocol.

Thus, the correct answer is A (The investigator/institution and the sponsor).

Reference:

ICH E6(R2), §8.2.2 (Signed protocol and amendments).

ICH E6(R2), §4.5.1 (Investigator compliance with protocol).

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SOCRA CCRP Exam (page: 2) SOCRA Certified Clinical Research Professional Updated on: 24-Mar-2026

QUESTION: 9

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QUESTION: 11

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QUESTION: 12

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QUESTION: 13

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QUESTION: 14

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QUESTION: 15

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QUESTION: 16

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SOCRA CCRP Exam (page: 2)
SOCRA Certified Clinical Research Professional
Updated on: 24-Mar-2026