SOCRA CCRP Exam Dumps

The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.

21 CFR 312.44(b)(1): ''The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.''

21 CFR 312.42(e): ''If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.''

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed).

21 CFR 312.44(b)(1) (Termination of an IND).

21 CFR 312.42(e) (Clinical hold procedures).

The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff---regardless of employment source. Exact extracts:

ICH E6(R2) 4.1.1: ''The investigator should be qualified... and have adequate resources to properly conduct the trial.''

ICH E6(R2) 4.1.5: ''The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.''

ICH E6(R2) 4.2.5: ''The investigator may delegate... but retains responsibility for the conduct of the trial at the site.''

Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties.

ICH E6(R2) Good Clinical Practice, 4.1.1; 4.1.5; 4.2.5 (Investigator responsibilities; delegation and oversight).

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Informed consent is a fundamental ethical requirement. If it is violated in a device trial, the FDA requires rapid reporting.

21 CFR 812.150(b)(5): States that a sponsor shall submit to FDA ''any report of use of a device without obtaining informed consent, within 5 working days after the sponsor first receives notice of such use.''

This expedited reporting ensures FDA oversight of serious violations and protection of human subjects.

Incorrect options:

A (1 day) is overly strict and not codified.

C (10 days) and D (30 days) are too delayed to meet regulatory intent of immediate oversight.

Thus, the correct timeline is within 5 working days.

21 CFR 812.150(b)(5).

Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and how assent is obtained, in addition to parental permission. Exact extracts:

45 CFR 46.408(a): ''The IRB shall determine ... whether and to what extent children are capable of providing assent.''

ICH E6(R2) 4.8.12: ''Where a subject is unable to give consent personally, assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s).''

Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.

ICH E6(R2) Good Clinical Practice, 4.8.12 (Informed consent/assent).

45 CFR 46 Subpart D---Additional Protections for Children, 46.408(a).

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The Belmont Report (1979), issued by the U.S. National Commission, identifies three core ethical principles guiding human subject research:

Respect for Persons (informed consent, autonomy, protection of vulnerable populations).

Beneficence (maximize benefits, minimize harms).

Justice (fairness in subject selection and treatment).

The Nuremberg Code (1947) was developed post-WWII to prevent unethical experiments.

The Declaration of Helsinki (1964, updated) is a World Medical Association document guiding international physician research ethics.

The ICH Guidelines (1996) outline harmonized regulatory requirements for good clinical practice.

Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.

Thus, the correct answer is D (The Belmont Report).

The Belmont Report (1979), National Commission for the Protection of Human Subjects.

45 CFR 46 (Human Subject Protections).