Definition

Application to conduct a clinical trial in a given country. In the EU, submitted to national competent authority and ethics committee; format and content are harmonised.

Example

Before starting a trial in France and Germany, the sponsor submits CTAs to ANSM and BfArM (and ethics committees) and waits for approval.

Regulatory source

EU Regulation 536/2014, Directive 2001/20/EC

Common mistakes

Starting recruitment before CTA approval. Not notifying substantial amendments to the authority and ethics committee.

Inspector question

How do you track CTA approvals per country and ensure no trial activities occur before approval?

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