Please find below a summary of the last EU Clinical Trials Portal and Database Stakeholder Meeting at EMA which took place on 21 September 2016.
Project status update
- On track for independent audit by August 2017 and go live by October 2018 at the latest
- First two User Acceptance Testing rounds (UATs) have been completed and feedback incorporated. UAT 3 between 19 and 25 September
- No progress on the sponsor API (Application Progress Interface – i.e. submission of information from sponsor). More information beginning of 2017.
- Transition to the new FWC (framework contract) for system implementation is ongoing.
- No current plans to allow Sponsors to review the system and be able to review changes need to internal Sponsor process and impact on third parties – will be provided at a later date, following audit.
UAT 1 and 2 update
- EMA presented an update on UAT 1 and 2 and planning for UAT 3.
- Scope: First view of system, creating application, submitting application, evaluating application
- Fixes and improvements based on feedback from UAT 1 and 2 to be incorporated into UAT 3.
- Increased validation
- Streamlined interface, layout revised, wording of fields improved and duplication removed
- Upload of multiple documents
- CT number filter
- Highlighting mandatory fields with (*)
- Notifications when saving to highlight fields still to be completed or ready to submit
UAT 3 planning
- Increased number of testers; UAT 1: 457 testers, UAT 2 – 502 testers; UAT 3 – 562 testers
- Focal points introduced to liaise with EMA
- Increased survey based approach, central repository and two testing groups rather than one (smaller and larger testing groups in UAT 3)
- Scope of UAT 3: withdraw application, select RMS, assess Part II and reporting
- Question by Industry: when is EMA planning to provide with a draft system so companies can adapt their own systems in line with the portal? Sometime in 2017, most likely towards the audit time of the EU portal and database.
Use Case review update
- EMA presented list of use cases by Sponsor: create new application, cancel draft application, create substantial amendment, populate country dependent information, populate additional Sponsor information, complete trial details, complete product details, submit application, withdraw application (up until decision), create additional member state, manage application (search and select), prepare and submit response to RFI, search and select organisation, deliver opinion (related to corrective measure), manage tasks and messages (response to RFI within a specific timeframe), select notification type (at various stages of trial [e.g. initiation of trial]), create non substantial modification and user management.
- Draft applications not submitted will not be available to public and not viewed by member states. Concerns raised by Industry that even if Sponsors remove information for draft applications, an information trail will be included on portal
EMA clarified that the applicant’s workspace sits in a database different from the EU portal and database. The draft applications are kept in this applicant’s workspace.
- Applications submitted which are later cancelled will be available to member states and may be viewed by the public, depending on later status of product/trial.
- Teleconference planned with Sponsors on 4th October (trial milestones, start, restart and end of trial/termination) and with public on 10th October 2016 (public search and public CT information). Further teleconferences proposed for “view timetable” and “request deferral”
CT transition diagrams – high level concept
- High level process maps were presented for all steps of the application/trial with applicable use cases, linking Parts I and II assessment per member state:
- Application is created by the Sponsor for each member state
- Each member state is required to decide its own respective application
- Additional Member state (if approved) introduces a new member state trial element of the new additional member state
- System will allow submission of Part I only (and will highlight if Part is pending) or Part I and Part II together
- Initial (if not provided in initial assessment)/additional Part II cannot be provided until initial assessment is completed
- The re-submission option will be introduced for lapsed, withdrawn and rejected applications. This option will not be available for cancelled applications.
- Extensive discussion related to member states who do not agree with the outcome of the Part I assessment and tacit approval:
- EMA confirmed that tacit approval is allowable for Part II assessment within the system, the status will go to “authorised” if a member state does not respond to Part II (assuming Part I acceptable). For Part I, tacit approval is not allowed. Concerns were raised by industry representatives on automatic authorisation in no conclusion on Part II
- Member states who do not agree with Part I assessment by RMS, can disagree with outcome and would be removed from assessment (in accordance with Article 11 of the regulation), although a Part II can still be submitted for that member state within the system. The EMA confirmed will review this process
- Information provided on all possible scenarios, if after 5 days, having both Part I and Part II conclusions, but no application decision
- Public trial status is a lay person status and provides authorisation status plus a recruitment status in each member state
- Start of trial defined as start of advertisement and start of recruitment defined as FPFV within system, which may be different to terms used within protocol and stated in regulation
- The MHRA highlighted that the status ‘halt recruitment but continue the trial’ was not available in the portal and suggested it is considered by EMA. EMA confirmed they would look into it.
8 – User Management
- EMA presented to update on user management and access to portal and database
- Features and capabilities that enable users to manage access to CT within the portal
- Flow diagrams presented for access to CT portal and database
- Two options:
- Trial-centric – CT administrator, no sponsor admin, faster for an initial application, or
- Organisation centric approach for all CTs or specific CTs – sponsor admin, users affiliated to an organisation, requires authorisation by Sponsor admin, more formal registration and improved security. Note: Sponsor admin will have access to all clinical trials that the Sponsor is responsible for
- All users will need to be self-registered, proof of ID and evidence of appointment required
- Specific roles and permissions depending on activity required
- Revoking access of users has been introduced
- EMA advised that CT admin register a back-up
- MAH will have access to upload CSRs
- Current situation discussed by EMA is that all users will have access to all Work packages (WPs). Concerns from industry with regards confidentiality if all users have access to all information. Key item to feedback to EMA: CROs and third parties may not conduct all parts of CT process and there may be items which are confidential that may not be provided to a CRO (e.g. IMPD)
9 – Training needs assessment
- First step in developing training material for portal and database
- Key impacts of processes and major groups impacted were identified
- Survey completed, to review key processes and groups, by member states and Sponsor representatives and output presented
- Scope of training deliverables identified (e.g. user manuals, guides, videos etc.)
- Further surveys and more detailed plans to be provided
10 – EU Application Form update
- Proposed fields of form presented by EMA
- Proposed form to be similar to current CT form
- Mandatory and optional fields with option for multiple languages
- Will be linked to xEVMPD/IMPD systems for some fields
Commission Guidelines (x4 issued earlier in 2016 for consultation)
- Feedback received on draft guidelines to be discussed at next ad hoc group at the commission and released early next year
- Will not be formal guidelines issued by the commission
- Further guidelines to be issued at a later date by EMA (e.g. inspections, TMF)
The next stakeholder meeting on European Union clinical trials portal and Union database is planned on 24 March 2017, 10:00 – 17:00. As soon as we receive the official invitation we will let you know. At last week’s meeting the industry requested a meeting sooner than March 2017 (end of 2016 suggested) as a six month period to the next meeting was not considered sufficient, considering the amount of activity planned for this period and the type and number of comments from industry. EMA stated that they would consider this request but could not promise.
Thank you to EUCOPE members for creating these minutes!