Free SOCRA CCRP Practice Exam with Questions & Answers | Set: 2

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis 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. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

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

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor 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 for2 years following the date a marketing application is approvedor 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 isA (2 years).

21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.

ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.

Thus, site must first obtainIRB approval for revised protocol and ICF.

Before an investigator can commit to conducting a trial, they must review thestudy protocol.

ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.

ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator’s brochure and the current approved protocol.

Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.

The investigator has ultimate responsibility for site staff qualifications.

ICH E6(R2) 4.2.4:“The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions.”

ICH E6(R2) 4.1.5:Investigator must maintain current documentation of staff qualifications.

While sponsors and monitors oversee compliance, accountability rests with theclinical investigator. Coordinators may implement duties, but do not hold legal responsibility.

Correct answer:B (The clinical investigator).

Theprotocol signature pagedocuments 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 sponsor–investigator 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 isA (The investigator/institution and the sponsor).

21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.

21 CFR 11.10(a):Requires “validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

Validated systems ensure equivalency between electronic and paper records.

While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.

Thus, the correct answer isB (Managed within a validated computer system).

Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.

ICH E6(R2) 4.8.2:“If new information becomes available that may be relevant to a subject’s willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner.”

21 CFR 50.25(b)(5):Consent must include a statement that “significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided.”

Thus, the investigator mustcommunicate new risk information to the subject.

Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor’s role. Sharing subject contact with sponsor (D) would violate confidentiality.

Correct answer:C.

370 × 1.20 =444 mg/m².

Accurate dosing calculations are critical for protocol adherence and patient safety.

AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical investigation.

21 CFR 812.1(a):“An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.”

It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).

Thus, the correct answer isA (Shipped lawfully for clinical study).