Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 71

This text is not meant to serve as specific training for the regulatory affairs personnel in terms of application preparation and submission. Many other reference texts describe the ins and outs of that task. It is however useful to reflect on the importance of GCP when noncompliance with it can have a significant impact on the review and processing of applications.

All of the regulatory authorities who receive and process applications have established internal instructions regarding the evaluation of noncompliance with regulatory requirements. Serious deficiencies are evaluated for their impact on the continued review and evaluation of an application as well as whether the trial should continue to be conducted at a site(s) or be placed on hold. Any decision to place a trial on hold would be based on a risk‐benefit evaluation to determine whether the risk factor may have changed due to the deficiencies. If, for example, adverse experience reports had not been made in a timely manner or at all, then the risk of the non‐reporting will be weighed by the competent authority. Many such deficiencies are identified during inspections of sponsors and/or sites. Regulatory authorities also receive reports from sponsors of situations, e.g. in the UK a serious breach of the requirements impacting the safety of subjects must be reported.