In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical trial is in compliance with the requirements of the CTR, the sponsor shall adequately monitor the conduct of a clinical trial. The extent of the monitoring depends on:

  • whether the clinical trial is a low-intervention clinical trial;
  • the objective and methodology of the clinical trial; and
  • the degree of deviation of the intervention from normal clinical practice.

In addition, the sponsor should be able to guarantee:

  • Suitability of investigators and other individuals involved in the contact of the clinical trial
  • Suitability of the clinical trial sites
  • Traceability, storage, return and destruction of IMPs
  • Reporting obligations (see also section on Notifications)

All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.

Information on any changes to a clinical trial, which are not SMs but are relevant for the supervision of the clinical trials by the MSc, shall be updated in CTIS by the sponsor, in line with article 81(9) of the CTR. These article 81.9 changes can be submitted only if the change does not trigger additional changes, which are expected to be submitted as an SM application. The combination of different art 81.9 changes can cumulate into a change that needs to be submitted as an SM. See Annex III of the Q&A document for specific examples of Art 81.9 changes.

Clinical trial master file

The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file contains the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated. The clinical trial master file must be readily available, and directly accessible upon request, to the MSc.

The sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial, unless other Union law requires archiving for a longer period. See also Archiving.

Inspection reports

The sponsor shall submit to the MSc, through CTIS, all inspection reports of third country authorities concerning the clinical trial. When requested by a MSc, the sponsor shall submit a translation of the report or of its summary in an official language of the Union indicated in the request.