SOCRA CCRP Exam Dumps

FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.

21 CFR 812.3(m): Defines a ''significant risk device study'' as one that ''is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.''

Risk is judged within the context of the protocol --- i.e., use of the device in that particular study (D).

Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA's risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.

Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.

21 CFR 812.3(m) (Definition of significant risk device).

FDA Guidance on Significant Risk and Nonsignificant Risk Medical Device Studies.

Monitoring ensures trial integrity and subject safety.

ICH E6(R2) 5.18.3: ''The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.''

Monitoring must occur before (initiation visit), during (periodic), and after (closeout).

It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.

Correct answer: C (Timely manner before, during, and after).

ICH E6(R2), 5.18.3.

Record retention requirements ensure regulatory access to data even after development is discontinued.

21 CFR 312.62(c): ''An investigator shall retain records... for 2 years after the date a marketing application is withdrawn or discontinued and FDA is notified.''

In this case, development was terminated 15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is 15 May 2021, but FDA requires records to be maintained until after the 2-year period ends. The earliest permissible destruction date is 16 May 2022 (C).

Options A and B are premature; D (2034) is far beyond requirements.

Thus, the correct answer is C (16 May 2022).

21 CFR 312.62(c) (Investigator record retention).

21 CFR 312.57(c) (Sponsor record retention).

ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998): Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.

CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.

Record retention is critical for regulatory inspection and subject protection.

21 CFR 56.115(b): IRBs must retain records for at least 3 years after completion of the research.

ICH E6(R2) 3.4.3: Similarly requires retention of records for a minimum of 3 years after completion.

This allows audits, sponsor inspections, or regulatory reviews long after the study closes. Institutions may require longer retention, but federal minimum is 3 years.