Obtaining clinical trial approval (CTA)

Starting with the process, the sponsor must apply for certification to conduct a Clinical Trial Authorisation (CTA) for clinical investigations. Each European state has its own jurisdiction, which is considering the possibility of approving clinical trials.

CTA is a regulatory document sent to the National Health Authority stating that the sponsor intends to conduct a clinical trial of an IMP or an approved medicine in order to find a new indicator.

In order to be approved for clinical trials, the CTA application must include all necessary documents required by the National Health Authority. Rules for conducting clinical trials and safety requirements vary in different countries. The CTA is one of many important documents governing the conduct of clinical trials.