Clinical Research Professional CCRP SOCRA Study Notes

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.

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.

When reviewing protocols, IRBs/IECs are primarily responsible forsafeguarding human subjectsby evaluating risks, benefits, and fairness in subject selection.

21 CFR 56.111(a)(3):“In making its determination the IRB shall determine that… selection of subjects is equitable.”

45 CFR 46.111(a)(3):Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.

Other options:

Patient population availability (A) is afeasibility issue, addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by thesponsor and investigator, not IRB.

Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.

Thus, IRBs focus onjustice and fairness in subject selectionas part of the Belmont Report principles.

Belmont Report:“Respect for Persons” incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).

Prisoners require special safeguards because of restricted liberty and potential coercion.