Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which document includes the accountability records for investigational products?

1. Trial Master File (TMF)

2. Clinical Study Report (CSR)

3. Informed Consent Form (ICF)

4. Study Protocol

The correct answer is: Trial Master File (TMF)

The Trial Master File (TMF) is the comprehensive collection of essential documents and records that facilitate the conduct of a clinical trial. It plays a critical role in ensuring that the trial is conducted in accordance with regulatory requirements and good clinical practice. Among the various components of the TMF, accountability records for investigational products are included. These records detail the receipt, use, and return of the investigational products throughout the study. They ensure that all products are tracked accurately, promoting the integrity of the trial and ensuring patient safety. The other documents mentioned serve different functions within the clinical trial process. The Clinical Study Report (CSR) focuses on summarizing the methodology and results of the trial after its completion, rather than maintaining records during the study. The Informed Consent Form (ICF) is designed to inform participants about the study and obtain their consent, rather than keeping track of investigational products. The Study Protocol outlines the study design and methodology but does not include accountability records. Thus, the TMF is specifically tailored to encompass these essential accountability documents for investigational products.