Steering Committee Update & Membership Call - Project Progress Snapshot
Steering Committee updates include a call for new members, reminders for subscribers and project members, feedback on MHRA workshops, subgroup activity updates, milestone achievements, and upcoming conferences. Resigned committee members noted. Reference model subscriber details and communication tools highlighted. Emphasis on active participation for project working groups. Mock inspection exercise challenges discussed. Valuable insights into handling regulatory submissions and approvals, compliance assessment, and eTMF system utilization shared.
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Presentation Transcript
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
Resigned Committee Members Dorte Frejwald Christiansen, NNIT Call for new Committee Member Not Sponsor CRO or Vendor or Consultant Deadline 20thOctober for self nomination
Reference Model Subscribers Subscribers ~650 Maintaining & developing Reference Model & supporting tools Interested Stakeholders ~550 Project members ~100
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!Groups discussion tool (no change) Will not be used for documents, sub-groups etc 655 current subscribers
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
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
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
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
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.g PV, 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
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
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
SOURCE DOCUMENT COPY PROCESS CERTIFY? NOTES WHAT HAPPENS TO COPY? Photocopy filed in paper TMF No Original at investigational site and maintained in ISF e.g. delegation log Original at investigational site and maintained in ISF e.g. delegation log Original at investigational site and maintained in ISF e.g. delegation log Copy at investigational site and maintained in ISF e.g. EC constitution (original at EC) Microsoft Office document at site/CRO/vendor or deleted once transmitted to sponsor Photocopy made at site and brought or emailed to sponsor Original available for validation purposes if needed No Photocopy made at site and brought or emailed to sponsor Photocopy scanned. PDF filed in eTMF Original available for validation purposes if needed PDF filed in eTMF No Scanned copy uploaded via Sponsor eTMF portal Original available for validation purposes if needed No Photocopy made at site and brought or emailed to sponsor Photocopy filed in paper TMF or scanned and saved to eTMF No need to certify a copy of a copy No Original sent by email as attachment to sponsor (though technically, it is actually a copy) Original Microsoft Office document as received by sponsor filed in eTMF Microsoft Office document considered to be the original
SOURCE DOCUMENT COPY PROCESS CERTIFY? NOTES WHAT HAPPENS TO COPY? PDF saved in eTMF Microsoft Office document e.g. Word Printed or saved to PDF using standard out-of- the-box save as functionality Scanned copy uploaded to TMF and checked against original No (although could be it depends ) Save to PDF and Print to PDF is identical to Print to printer which does not need certifying Only if eTMF is primary TMF. Unclear Rationale for certification Scanned copy is replacing the original which is being destroyed PDF filed in eTMF Yes Wet-ink paper original held by sponsor and maintained by sponsor PDF filed in eTMF Yes Paper original held by sponsor and destroyed after eTMF upload e.g. SAP Paper original held by sponsor is archived after eTMF upload e.g. filenote Scanned copy uploaded to TMF and checked against original PDF filed in eTMF Yes Scanned copy uploaded to TMF and checked against original Unclear Rationale for certification
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 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
Thanks to volunteers! Still need members for: Zone 3, Zone 4, Zone 6, Zone 7, Zone 8, Zone 9, Zone 10, Zone 11
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
Group Metadata Implementation toolkit / Upgrade User Guide Sub-artifacts Country specific artifacts Milestones Single Site Structure Survey TMF Plan Template Exchange Mechanism Change Control Board Lead Todd Tullis Mike Czaplicki Lisa Mulcahy Karin Schneider Eleanor Hewes Kathleen Kirby Karen McCarthy Shau Jane Twitchen Jamie Toth Paul Fenton / Elvin Thalund (Eldin Rammell)
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.
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
QUESTIONS? QUESTIONS? Join the TMF Reference Model Yahoo! Group http://tmfrefmodel.com/join Knowledge sharing Networking Too Much Fun! http://tmfrefmodel.com/join
