The reporting of GCP issues, also called “serious breaches”, to regulatory authorities is already obligatory in some countries (e.g. in UK), and will become a statutory requirement within the EU with the implementation of the new Clinical Trials Regulation. The regulatory authorities expect not only the notification of the issue itself, but also a description of follow-up measures taken by the sponsor. We can support you in handling problems with GCP compliance. We support you in:
- Assessing the impact of the GCP issue
- Drafting and implementation of a CAPA Plan
- Drafting the Serious Breaches Report
- Responding to possible regulatory authority questions