The Pharmaceutical Affairs Branch (PAB) in the Office of Clinical Site Oversight (OCSO), within the Division of AIDS (DAIDS) is responsible for performing the following key functions:
- Provide expertise on all pharmaceutical aspects of protocol development and conduct.
- Coordinate and provide oversight of the Clinical Research Products Management Center (CRPMC) to ensure that study product supply, packaging, blinding and distribution activities for all the DAIDS-sponsored and/or supported clinical trials are performed in accordance with DAIDS requirements.
- Establish processes, oversee and monitor adherence to quality assurance standards and standard operating procedures for all pharmacy and product-related issues at the clinical research sites participating in the DAIDS-sponsored and/or supported trials.
The DAIDS is responsible for complying with regulations and requirements governing the management of study products used in DAIDS clinical trials which include:
- U.S. Food and Drug Administration (FDA) regulations
- International Conference on Harmonization (ICH)/ Good Clinical Practice (GCP) requirements
- Regulations outlined by other international authorities, such as the European Medicines Council (EMA).
DAIDS has the responsibility of ensuring that all investigators conduct DAIDS-sponsored and/or supported clinical trials in accordance with the protocol, U.S. federal regulations, in-country regulations, provisions imposed by the Institutional Review Board (IRB)/Ethics Committee (EC), and any other applicable regulatory entities. DAIDS requires that the Principal Investigator/Investigator of Record (PI/IoR) delegates the responsibility of study product management to a licensed/registered Pharmacist of Record (PoR).
The DAIDS Pharmaceutical Affairs Branch (PAB) has established the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks which describes the required pharmacy and study product management standards for the conduct of DAIDS clinical trials and includes requirements for personnel, facilities, equipment, and processes. Pharmacists are expected to follow these guidelines, in addition to their local and country regulations governing the practice of pharmacy.
The CRPMC has been established to support the DAIDS Clinical Trials Networks. As a contract of the DAIDS, the CRPMC centrally manages the receipt, storage, and distribution of study products.
The training courses listed are required for the site Pharmacist of Record and Associate Pharmacist(s), and recommended for other site pharmacy personnel involved in DAIDS clinical trials.
Related Training Courses on the DLP
| Name | Description/Audience |
|---|---|
| DAIDS Clinical Trials Networks Pharmacy Guidelines Training | This course provides an overview of the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks and is composed of six modules as follows:
|
| Essential Documents | This course covers the purpose of essential documents and how to accurately generate, complete, maintain, and/or submit them (to Institutional Review Boards/Ethics Committees, regulatory authorities, or DAIDS) during a clinical trial. |
| Source Documentation | This course covers the role that source documents and data play in clinical trials, explains how to apply the ALCOA-C principles and other Good Documentation Practice requirements, introduces the process of de-identification, and discusses how to analyze, correct, and prevent source documentation errors. |
| Monitoring 101 | Overview of the DAIDS Monitoring process. |
| Clinical Site Monitoring (CSM) System Training | Overview of the DAIDS Clinical Site Monitoring (CSM) System. |
| Clinical Quality Management Plan (CQMP) |
Four modules regarding site Clinical Quality Management Plan (CQMP) requirements, and associated tools.
|
| Corrective and Preventative Actions (CAPA) | Defines what a CAPA is, how it is developed and when it is used. |
| Inspection Awareness and Preparedness for CRS Inspections | Three modules giving an overview of what regulatory inspections at a CRS involve, what can be expected, and how to prepare. |