An article “Massive Functional Problems of the EU Clinical Trials Portal CTIS Threaten Drug Research in Europe” was published on the Bundesverband der Pharmazeutischen Industrie (BPI) website on November 28, 2022, by the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK).
The AKEK has requested that the transitional period for EU CTIS pursuant to Article 98 (2) of Regulation 536/2014 expiring on 31 January 2023 to be extended until the functionality of the EU portal CTIS has been established and demonstrated. The cause of this request to extend the timeline is due to two major issues raised by the Reporting Member State (RMS)/Member State Concerned (MSC) following RFIs (Requests for information) in CTIS.
The CTIS team has acknowledged the inconvenience caused to the users and has assured to resolve the issues and restore full functionality of the RFI module. EMA will inform the CTIS user community as soon as the issues are resolved. Below are the issues raised and their workarounds suggested by the CTIS team:
Issue 1: RMS/MSC can raise the first RFI, however depending on the timing they may not always provide the maximum number of days (10 and 12 respectively in validation and part I) for the sponsor to respond.
Workaround: It is advised to RMS/MSC to raise the first RFI as soon as possible, thus enabling the extension of the timer. The RFI should include a simple query that will allow sponsors to respond on time; RMS/MSC may provide sponsors with a shorter due date than the maximum 10 or 12 days (in validation and part I respectively). Sponsor users have to respond to this first RFI in accordance with the indicated due date. RMS/MSC can then prepare a second RFI, allocating the maximum number of days for the sponsor to respond.
Issue 2: MSC/RMS cannot raise the first validation RFI on day 10 or day 6 for an initial application or substantial modification respectively. MSC/RMS cannot raise the first part I assessment RFI on day 45 or 38 for an initial application or substantial modification respectively.
Workaround: It is advised to RMS/MSC to plan the submission of the first RFI to avoid submission on the last day of the validation or part I conclusion. In case a submission of the first RFI on the last day is required, RMS/MSC may raise a ticket with CTIS User Support Service to ask for the RFI to be created on their behalf.