Quality control of clinical trials of medicinal products: in Q1–Q3 of 2024, the Center conducted 30 clinical audits, with significant deficiencies identified in 6 of them.
A clinical audit of a clinical trial of a medicinal product is an important aspect of ensuring its quality and confirming the protection of the rights, safety and well-being of trial subjects.
In order to verify compliance with regulatory requirements during the conduct of clinical trials of medicinal products, the rights of trial subjects, and compliance with the principles of Good Clinical Practice (GCP), the Center, as an organization authorized by the MoH, conducted 30 planned clinical trial audits over the first three quarters of the current year. According to the Audit Department, only 3 of them had no findings. Minor findings were recorded in 21 clinical audits (CAs), while 6 CAs revealed major deficiencies that could negatively affect the rights, safety, and health of trial subjects and/or the quality and integrity of the data.
The main observations identified during the audits related to:
- creating the investigator's file;
- keeping primary medical documentation;
- the activities of ethics committees;
- the procedure for obtaining patients’ informed consent;
- circulation/labeling of investigational medicinal products;
- maintaining individual case report forms and others.
We draw attention to the fact that, in accordance with the legislation, significant deficiencies must be corrected in a timely manner within the deadlines set based on the results of the clinical audit, with written notification of their elimination submitted to the Center.
We remind you that, in order to raise awareness among researchers, doctors, members of local ethics committees and others involved in the conduct of clinical trials, the Center regularly holds monthly training seminars on regulatory and legal matters and compliance with Good Clinical Practice (GCP) in the conduct of clinical trials. The Center's specialists will hold the following upcoming seminars:
Clinical audits are currently ongoing.
The plan for the 4 quarter can be viewed on the Center’s website at the link http://surl.li/isfnsl
