SOCRA CCRP Exam With Confidence Using Practice Dumps

Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.

21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.

The witness ensures that oral consent was properly conveyed and understood.

The person obtaining consent must sign aseparate written summary, but not the short form itself.

Thus, the accurate answer isA: subject (or LAR) + witness.

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1:“The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.”

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer:A (The clinical investigator).

21 CFR 56.109(a):IRBs must review all changes to informed consent before implementation.

ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.

Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.