Conducting international studies

Please note that you must always apply for sponsorship of the entire study before having country-specific documents reviewed.

In the case of an international clinical trial, sponsor tasks are usually delegated to a central national institution in the relevant country.

Before allocation of delegating sponsor tasks to this national institution, the sponsor must fulfill its selection responsibility and ensure that the institution is qualified of performing these tasks (vendor assessment). This is primarily assessed on the basis of documents and information obtained and documented accordingly. In individual cases, a decision must be made as to whether an additional on-site audit is necessary. 

Once the review and documentation have been completed, the allocation of tasks and responsibilities is regulated by contract. Corresponding contract templates are available from Sponsor-QA and must be adapted to the specific project. For third countries outside the EU or EEA, please contact Sponsor-QA. 

An overview about the information and documents that should be obtained in advance from the cooperation partner in the participating country prior to the delegation of sponsor tasks can be found here. 

Regarding a SOP template for the general vendor assessment process, including a checklist to be adapted to the requirements of the project, please contact uni-sponsor(at)uk-koeln(dot)de.