SOCRA CCRP - Certified Clinical Research Professional (CCRP)

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

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.

TheBelmont Report (1979)establishedthree key ethical principles:

Respect for Persons:Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.

Beneficence:Obligation to maximize benefits and minimize harm.

Justice:Ensuring fairness in subject selection and distribution of research burdens/benefits.

Voluntary informed consent embodiesRespect for Persons, as subjects are given adequate information and freedom of choice. “Do no harm” (A) is a Hippocratic principle but not Belmont terminology.

Thus, the correct answer isB (Respect for persons).

The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid… when considering the adequacy and completeness of the written information to be provided to the subjects.”

21 CFR 56.109(b):“The IRB shall require that information given to subjects as part of informed consent is in accordance with §50.25.The IRB may require that information, in addition to that specifically mentioned in §50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects.”

This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.

Thus, the correct answer isA (At any time, at the discretion of the IRB/IEC).

420 subjects ÷ 42 months (3.5 years) =10 subjects/month.

However, “expected average” often rounds up to next whole number, ensuring enrollment goals are met. Thus,11/monthis correct.

This calculation is important for feasibility assessments and protocol planning.

Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).

45 CFR 46.109(f):“Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk.”

ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.

Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.

Thus, the correct answer isD (No such requirement).

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).

ICH E6(R2) 5.6.1:“The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial.”This ensures transparency in compensation, reimbursement, and budget.

Form FDA 1572 is the “Statement of Investigator” for IND studies.

21 CFR 312.53(c)(1)(vi)(b):Requires investigators to “read and understand the Investigator’s Brochure.”

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B–D) are not part of 1572 requirements.

Correct answer:A.