CCRP Dumps with Practice Exam Questions Answers

ICH E6(R2) 4.6.1:The investigator is responsible for investigational product accountability at the site.

21 CFR 312.61:Investigators must administer the investigational drug only to subjects under their supervision.

The IRB maintains meeting minutes (A), preclinical studies are sponsor tasks (B), and financial interest documentation (C) is covered under sponsor reporting. Thus,D is correct.

Recruitment materials must be reviewed to protect subjects from misleading or coercive messaging.

21 CFR 56.111(a)(3):IRBs must ensure equitable subject selection.

ICH E6(R2) 3.1.2:IRBs safeguard rights, safety, and well-being, including review of recruitment strategies.

FDA and OHRP do not approve recruitment materials; responsibility lies withIRB/IEC.

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).

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d):“Each IRB shall include at least one member whose primary concerns are in nonscientific areas… andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.”

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).

During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.

ICH E6(R2) 8.1 & 8.4:Lists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.

21 CFR Part 11:Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.

Thus, the critical items for monitor review at closeout areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).

Correct answer:D.