19/20 March 2024
The European Commission (EC) published an updated Version 6.2 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022.
Compared to the previous Version 6.1 the following new Q&A has been introduced:
1.24 How are patient facing documents expected to be submitted ?
Patient facing documents are documents presented to clinical trial (CT) participants during the conduct of the CT. These can be questionnaires, patient diary, patient card or patient reported outcomes. Patient facing documents will need to be submitted in line with the language requirements for the protocol and should be provided to the CT participants in a language understandable for the participants. Sponsors are responsible for ensuring the quality of the translations to be provided to the participants. However, there is currently no legal basis in the CTR to request the submission of all patient facing documents in the part II documentation package and/or to require their translation.
The following Q&As have been updated:
2.6 Chapter X and Annex VI of the Clinical Trials Regulation refer to the content of the labelling of the investigational medicinal product (IMP). Does this mean a mock-up needs to be submitted?
No, only the text that is labelled on the IMP should be included in the application dossier. The label text submitted should be in a tabular format following structure given in Annex VI. If any information is omitted from the label because it is made available by other means, for example by use of a centralised information system, reference should be made to the exact section in the protocol where the information can be located or where justification for omission is provided.
3.8. How should a sponsor proceed when a substantial modification (SM) is related to a document common to various clinical trials of the same sponsor and same IMP?
There are two possibilities available to submit a SM to the IMPD (Investigational Medicinal Product Dossier) in multiple trials:
In addition, Chapter 11 (Arrangements for the transitional period) has been updated and the requirements for DK, EL, LV, HU, SE have been adapted in Annex II: Language requirements for part I documents.
More information can be found in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.2 in EudraLex - Volume 10 - Clinical trials guidelines.