SOCRA CCRP Exam Dumps

The Investigator's Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.

ICH E6(R2) 7.3: ''The sponsor should revise the IB as soon as new, significant information becomes available.''

ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.

Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.

Thus, the correct answer is D (No notification is required).

ICH E6(R2), 7.3 (Updating the Investigator's Brochure).

ICH E6(R2), 4.1.5 (Investigator responsibilities for informing staff).

ICH E6(R2) 1.52: Source documents are ''original documents, data, and records... necessary for the reconstruction and evaluation of the trial.''

Their main role is to document treatment and verify CRFs.

Audits are part of sponsor quality assurance to ensure trial compliance.

ICH E6(R2) 5.19.3: ''The sponsor's auditing procedures should include the provision of an audit certificate where required.''

ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.

IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.

Correct answer: D.

ICH E6(R2), 5.19.3.

ICH E6(R2), 8.2.20.

Children who are wards of the state receive additional protections in clinical research.

45 CFR 46.409(b): For research involving wards, ''the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided.''

The advocate must have background and experience to act in the child's best interest and cannot be associated with the research.

Thus, an IRB-appointed advocate is mandatory to ensure independent representation of the ward's rights.

The U.S. Code of Federal Regulations (CFR) specifies when sponsors must notify FDA of changes to investigational drug studies under 21 CFR 312.30. A protocol amendment is required if there is:

A change to the protocol (e.g., objectives, design, subject population, dosing, or procedures).

The addition of a new investigator.

A change in the chemistry, manufacturing, or controls (CMC) that could significantly affect product quality or safety.

Among the listed options, a change in the manufacturing site (D) directly falls under significant manufacturing changes, requiring FDA submission. Changes in investigator financial interests (B) are covered under 21 CFR 54 and reported separately, not as protocol amendments. Addition of a sub-investigator (C) does not require a formal amendment, only site-level documentation and delegation log update. Addition of a monitoring test (A) may affect the protocol, but not necessarily mandate an amendment unless it changes objectives or subject safety endpoints.

Therefore, the correct answer is D. This ensures FDA oversight of product safety, efficacy, and compliance with CMC standards before investigational use.

21 CFR 312.30 (Protocol amendments).

21 CFR 312.23(a)(7) (Chemistry, manufacturing, and controls information).