FDA clinical trial inspection program, known as bioresearch monitoring (BIMO), is aimed to ensure the quality and integrity of data and information submitted to the Agency in support of research and marketing applications – i.e., IDE, PMA, and 510(k) submissions – and to ensure that the clinical data has been collected in a manner that protects the rights, safety and welfare of properly consented clinical trial participants.
Sponsors, IRBs, and investigators, or any person acting on their behalf, are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy records relating to a clinical study under evaluation. Any establishment where devices are held, including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept, are subject to BIMO inspection. It is, therefore, indispensable that clinical sites be ready for a BIMO inspection at a moment’s notice, which practically means being constantly prepared.
The purpose of this session is to discuss several strategies that clinical sites can employ to ensure they are “inspection ready” at all times.