Table 4 Selected technical issues
From: Experiences and challenges with the new European Clinical Trials Regulation
Issue | Description |
|---|---|
Non-substantial modifications | It is not possible to submit non-substantial modifications to the protocol, in contrast to the information given in the CTR Q&A, Annex IV. Currently, a substantial modification must be used for this purpose, which is time- and resource-intense. |
Public website inconsistencies | The public website does not provide the latest approved versions of the documents. AXL-SolidAct, protocol version 1.4 was approved after submitting an SM but when downloading the full trial dossier from the public site an older version 1.3 is included. The same applies to the ICF. This is a major issue because stakeholders (i.e. patients) will access incorrect versions of essential trial documents. One formal document presenting the up-to-date situation with the latest approved version of documents and listing which countries are approved (and on which date) would be helpful as many peripheral entities require this information, such as data protection officers, pharmacies, and drug handling partners. |
Part 1-Only Approvals | The technical solution to submitting a SM while there are Part I-only member states included is not yet implemented (as promised by the CTR Q&A document Question 3.6). When the first SM for AXL-SolidAct was submitted, four previously approved countries (Germany, Austria, Hungary, and Portugal) had to be withdrawn. Adding these countries later will cost a further 4 months. |
Workarounds | In the MOSAIC study, it was not possible to update the Part II dossier in response to an RFI due to a technical fault in the system that lasted several weeks. On the advice of the CTIS management team, and to avoid a lapse in the RFI, 167 updated study documents had to be appended to the RFI itself, with a promise that they would be uploaded when the issue was fixed. |
CTIS not a primary registry | CTIS is not registered as a primary trial registry in the International Clinical Trials Registry Platform (WHO ICTRP), and therefore do not fulfil the formal requirements scientific journals have for preregistration of clinical trials. Under CTD the EudraCT registry was a primary registry. |