Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Study records must be maintained by the investigator for a minimum of two years after the marketing approval of the drug for the indications being studied. This requirement is established to ensure that all relevant data and documentation are available for review, in case of audits or investigations into the conduct and results of the study. Retaining records for this duration provides an opportunity for regulatory agencies and sponsors to access information that can support the safety and efficacy claims made for the drug, even after the study has concluded.

In the context of clinical research, maintaining detailed records is crucial for verifying compliance with Good Clinical Practice (GCP) and for ensuring the integrity of the data collected during the trial. Records need to be available to respond to any questions that might arise post-marketing, especially considering that new findings may surface after the initial approval based on the long-term effects of the drug.