Regulatory services

The NCRC office provides the following regulatory services.

For scientific projects that are not carried out according to AMG or MPDG

Services

Consulting services
Providing templates and samples (e.g. ethics application, documents for participants)
Review of application documents
Review, preparation and submission of application documents for initial submission
Data protection: Preparation of the VVT* / incl. review of the security concept and submission of the documents to the CTO
Review, preparation and submission of documents for change requests
Study registration (public register)

For clinical trials according to AMG

Services

Consulting services
Providing templates and samples (e.g. trial protocol, documents for participants)
Review and preparation of application documents for initial submission incl. support in preparing a risk assessment
Obtaining approvals from the responsible federal authority/ethics committee
Obtaining offers for subject insurance
Obtaining offers for the production of the trial medication
Data protection: Preparation of the VVT incl. review of the safety concept and submission of the documents to the CTO
Checking the qualification certificates for trial sites and investigators and submitting them to the relevant ethics committee(s)
Notification to local authorities
Review, preparation, and submission of documents for change requests
Study registration (public register)
Review and submission of study reports

* Register of processing activities