After the sponsor’s auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is…

According to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems. An audit is a key component of this system, conducted to evaluate trial conduct and compliance. The sponsor initiates the audit and is therefore responsible for all related procedures, including the formal communication of its completion. The audit certificate is a document provided by the sponsor to the audited party (the clinical site) to confirm that an audit was conducted. This is a direct responsibility of the sponsor as part of their oversight duties for the clinical trial.

A. The IRB/IEC: The Institutional Review Board/Independent Ethics Committee is responsible for ethical oversight and protecting subject welfare, not for managing or reporting on the sponsor's quality assurance audits.

B. The regulatory authority: Regulatory authorities (e.g., FDA) conduct their own inspections and issue their own reports (e.g., Form FDA 483); they do not issue certificates for sponsor-initiated audits.

C. The Data Safety Monitoring Board: The DSMB is an independent body that reviews accumulating safety and efficacy data; it is not involved in the sponsor's quality assurance audit process or its documentation.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R2). 9 November 2016.

Section 5.19.3: "The sponsor should provide an audit certificate." This section explicitly states the sponsor's responsibility.

2. U.S. Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 312 (21 CFR 312), Investigational New Drug Application.

Section 312.50 (General responsibilities of sponsors): This section outlines the sponsor's overall responsibility for selecting qualified investigators, ensuring proper monitoring, and ensuring the investigation is conducted in accordance with the general investigational plan, which implicitly includes quality assurance activities like audits.

3. Knabb, E., & Roe, K. (2019). Chapter 10: Sponsor Responsibilities. In Fundamentals of Clinical Research: A Universal Guide for All Specialties (3rd ed.). Society of Clinical Research Associates (SOCRA).

This chapter details the sponsor's obligations under GCP, including the implementation of a system to manage quality throughout all stages of the trial process. The responsibility for auditing and communicating audit outcomes falls directly under this quality management framework.