SOCRA CCRP Exam Dumps

In device trials, unanticipated adverse device effects (UADEs) must be promptly reported.

21 CFR 812.150(a)(1): ''An investigator shall submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.''

In this case, severe burns with blistering go beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as a UADE and triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a 10 working day maximum timeframe.

Thus, the correct answer is D (10 working days).

21 CFR 812.150(a)(1) (Reporting requirements for investigators).

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.

21 CFR 312.8(b): Sponsors may charge for investigational drugs only if they demonstrate that the drug provides potential clinical benefit and a significant advantage over existing therapy.

FDA must approve charging requests.

The informed consent process must include all basic elements listed in federal regulations.

21 CFR 50.25(a)(4): Requires ''a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.''

ICH E6(R2) 4.8.10(c): Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.

This ensures the ethical principle of Respect for Persons (Belmont Report), giving subjects the autonomy to choose among reasonable medical options.

Incorrect options:

A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.

B: Financial disclosures may be required for IRB review, not subject-facing.

C: Subjects do receive a copy, but it is not a required consent element in regulations.

Correct answer: D.

21 CFR 50.25(a)(4).

ICH E6(R2), 4.8.10(c).

ICH E6(R2) 5.5.3: Sponsors are responsible for validating computerized systems used in trials.

Investigators ensure proper data entry, but system compliance lies with sponsor.