1 / 23

General Meeting

This meeting agenda includes updates from the steering committee, feedback from the recent MHRA workshop, and reminders on subscribers and the move to IO and MailChimp. It also mentions the resignation of committee members and the call for new committee members.

jmar
Download Presentation

General Meeting

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. General Meeting 11 September 2017

  2. Agenda • Welcome • Steering Committee Update – Call for new member • Reminder on subscribers / project members • Reminder on move to IO and MailChimp • MHRA workshop feedback • Subgroup activity update • Milestone group • Upcoming conferences

  3. Steering Committee Update • Resigned Committee Members • Dorte Frejwald Christiansen, NNIT • Call for new Committee Member • Not Sponsor • CRO or Vendor or Consultant • Deadline 20th October for self nomination

  4. Reminder of New structure Reference Model ‘Subscribers’ ~650 Interested Stakeholders ~550 Maintaining & developing Reference Model & supporting tools Project members ~100

  5. Subscribers • Kept up-to-date with news • Notified of project update meetings • Materials available on website and notified of updates • Communication of important updates • Communication tool: MailChimp • Free • Easy for self-serve (subscribe link from website and update own profile) • Opt-in to Yahoo!Groupsdiscussion tool (no change) • Will not be used for documents, sub-groups etc • 655 current subscribers

  6. Project Members • Only those participants on project working groups e.g. • zone groups • artifact sub-type group • dating conventions group • New collaboration platform (groups.io) • New members will be asked which group they’re joining • Project team is for ACTIVE participants  • 184 current Project Members

  7. MHRA Workshop – 5th September 2017(Karen Roy, Eldin Rammell, Jane Twitchen, Kathie Clark, Scott McCullogh, Fran Ross, Marie-Christine Poisson-Caraval, Dorte Frejwald Christianson)

  8. Overview of the Day • Mock Inspection: Practical exercise to highlight the challenges • Regs and Ethics submissions and approvals in separate artifacts = a challenge • MHRA presentations on: • Assessing Compliance from Documents, Data and eSystems • The Inspector’s User Requirements for TMF • Sponsor, CRO and vendor presentations on: • Inspection Challenges and EMA Guidance Assessment (Vittoria and Mieke) • eTMF is a one-stop shop system • Direct Access • Demonstrating oversight • Draft document • Data migrations

  9. Overview of the Day • Sponsor, CRO and vendor presentations on: • Fixing the Problems (Ivan and Lorrie) • Planning a QC programme • Management of email • Certified copies • Measuring a TMF • Inspection Readiness • Draft copies • Challenges when involving multiple organisations (Karen and Scott) • Multiple models • RACI and Oversight • TMF Source • Inspections • TMF Archive

  10. Key Challenges / Points Raised by the MHRA • Bringing together EC / Regs submissions and approvals • Ensuring that the presented TMF structure is accurate to the specific TMF being inspected (but keep a standard company structure) • Identifying documents through naming conventions • Lack of sign-posts for document location esp. IMP documents • Lack of 3rd party vendors document and audit trail retention • Remote review – the MHRA do not yet have a procedure in place to facilitate this (although something they’re keen to do in the future) • Data Warehouses – the MHRA very keen to have access to these and any reports that give insight to study/system status

  11. Key Questions Addressed • Data vs Documents • No issue maintaining in another system with guided access (and sign posts) • Could produce and file a summary report in the eTMF e.g. IRT • Multiple systems acceptable – e.gPV, eCRF, stats, eTMF • Audit trail management • Excel required to interrogate (v. large), PDF to prove no changes (but cant interrogate) • The sponsor should have an SOP or processes documenting how they use the Audit Trail (i.e. it’s not just a tool for the inspectors) – It is acceptable to review validated reports rather than audit trail directly • Challenge – balance vs effort, impact of patient safety, lack of alignment of MHRA to audit trail definition

  12. Key Questions Addressed • Draft documents • There is no requirement for draft documents to be in the TMF, only final documents are required (unless a track changed draft was submitted to an Ethics Committee or Regulatory body) • There is a need to show evidence that the review process was followed for key documents such as the protocol • There is a need to show a summary of all comments raised for these key documents • Draft versions may be used to confirm that organisations were compliant to review process or a separate document to track the changes e.g. meeting minutes can be filed • Archiving and native format • Retain documents in native format as far as possible • It’s most important to be able to interrogate the data/have it in its original format • Mobile document capture • Acceptable if original stays at Site • Security access an issue to be addressed

  13. Certified copies • 2 clear messages – but require clarity • Certification NOT needed if original remains in ISF (Reg Binder) or sponsor TMF • i.e. certification only if copy is permanently REPLACING the original (original destroyed or otherwise not available) • Except: certification needed if eTMF presented to MHRA as the official TMF

  14. MHRA Next Steps • Write up the event and publish on MHRA website • Review feedback and submitted questions to identify potential MHRA FAQ updates • Commence review of EMA consultation comments together with feedback received via this event (start this autumn with EMA IWG subgroup) • Meet with stakeholder groups for opinions concerning specific areas in the EMA guidance as required

  15. Change Control Board • 15 members – no additional members needed • Inaugural meeting to be scheduled imminently! • Vacancy: Chair • Joanne Malia, Regeneron: Deputy Chair • Gift Chareka, UCSF: Exchange Team Liaison • Eldin Rammell: Steering Committee Liaison

  16. Zone Teams • Thanks to volunteers! • Still need members for: • Zone 3, Zone 4, Zone 6, Zone 7, Zone 8, Zone 9, Zone 10, Zone 11

  17. Milestones Working Group • Group Objective • Align each artifact with simple, pre-defined study milestones • To give guidance to the TMF Reference Model Users by when they should have an artifact in the TMF • Organized into 3 study phases: start up, conduct, close out • TMF Levels taken into account: trial, country, site • Milestone is two dimensional • The point in time when an artifact should be in the TMF • By this point in the study (milestone), the TMF should be up to date • Included 2 milestones for long term studies • Team developed a User Guide and Q&A • Users can add to or reduce the list based on their own practices

  18. Activity Subgroups

  19. eTMF Conferences coming up • DIA Operational Excellence Forum, Berlin 12 to 14 September • EXL TMF Summit, Japan, September • IQPC TMF Conference, September, Amsterdam • EXL TMF Summit, London, October • Plus Inspection Readiness, Quality forums etc.

  20. TMF RM General Meetings • 6 – Nov • Add to your calendar NOW or download the calendar file (.ics file) when you receive the meeting notification from MailChimp • Outlook Meeting Request no longer distributed

  21. QUESTIONS? Join the TMF Reference Model Yahoo! Group http://tmfrefmodel.com/join • Knowledge sharing • Networking • Too Much Fun!

More Related