etmf From Libraries of Paper to Electronic Filing Cabinets to Databases

Transcription

1 ClinTech 2014 etmf From Libraries of Paper to Electronic Filing Cabinets to Databases 12 March 2014 Kelley Robinson TMF Process Analyst

2 Why an etmf Platform? A dynamic solution to enable active contribution, organization, maintenance and monitoring of TMF documents As part of the solution, Pfizer has built the necessary controls and measures to proactively manage quality in real time Multiple Repositories Paper and Electronic Single, Centralized etmf Repository Disclaimer: Screen Shots of PTMF Contain Test Data and Do Not Reflect Actual Pfizer Clinical Trials 2

3 Building Blocks of Analytics Framework Standards Quality as absence of defects Defining defects deviations from standards And of course, an etmf to collect, capture and display the data 3

4 Developing the Master Document List Meeting regulatory requirements Documentation necessary to reconstruct the conduct of Pfizer s trials in accordance with standards of ICH, GCP and using the DIA TMF reference model Comprehensive Master TMF Document List to meet MHRA and EMA standards Creating The TMF Standard Document List Pfizer s essential documents for Pfizersponsored trials Pfizer s document list for on-going studies The drug information association (DIA) TMF reference model document Document List Core Team Dedicated group of subject matter experts 17 Functional Lines / Partner disciplines and over 60 country/office reps to ensure accuracy Validation against Pfizer s Clinical and Medical SOP s Change Control Committee Change request management Subject matter experts from all functional lines, partner disciplines, tech reps and SOP reps, CRO Creation of an electronic TMF Document List Change Request 4

5 CTQ standards for an etmf An interactive metrics function allows users to monitor outcomes and take control of the TMF process Critical to Quality development identified three measures to ensure the highest standards in the TMF Do documents coming into TMF meet TMF readiness criteria? Do we have everything that should be in the TMF? Are required documents flowing into the TMF as they are created or collected? TMF Document Quality Preliminary checks (final, electronic formats, links) Completeness (all fields, all pages, all signatures) Scanning accuracy (legibility, skewing, orientation) TMF Completeness Actual vs. expected at point in time Expected documents based on study-specific document list and study / site milestones TMF Timeliness Internal expectation: within 35 days from receipt to finalization or milestone 5

6 Identifying Defects in Document Quality Preliminary QC checks: assess documents against well defined criteria Document completeness, indexing and scanning accuracy TMF Readiness Criteria Document Completeness Indexing Scanning Agency Documents should have all required fields completed and accurate No missing pages No blank pages Required signatures complete TMF Document Specialist must ensure the document(s) is correctly indexed and check for: Correct site number Correct document type Correct date per master doc list Document Owner must verify scanned copies are replicas of the original hardcopy documents No missing pages All pages are legible Pages are oriented correctly 6

7 Accountability and Compliance The interaction across different roles A critical part in the success of the etmf process 1 Define TMF specification 2 Create documents Document Owners creates and/or collect documents and verify that they are TMF-ready. 3 Submit Documents Document Owners submit and index documents to the TMF. 4 5 QC Documents TMF Document Specialists reviews and checks documents Monitor Performance TMF Study Owners and Document Owners review and monitor TMF quality and compliance TMF Study Owner will develop and finalize studyspecific TMF specification with relevant study team members and functional lines. 7

8 Scope and scale The need for a robust control plan A control plan supported by performance data, enabled by a well defined governance model Enabling highly visible metrics to ultimately improve the quality outcome of; Hundreds of ongoing clinical trials Pivotal trial defense In more than 60 countries Amassing 900 gigabytes of data Controlling the ever soaring numbers of documents for regulatory inspections; Total number of studies in PTMF = > 450 Total number of documents in PTMF = >1.3M approx. Average number of documents per month = 60K 80K Total PTMF Users = > 7K 8

9 Managing TMF standards within an etmf Pfizer s Specific Study Document List (SSDL) How we adhere to standards of process, reliable metrics and QC controls 1 etmf SSDL set-up and maintenance Establishes that each Study SSDL is complete and the TMF Completeness metric is reliable prior to activation in the etmf 2 etmf metrics TMF Completeness TMF Document Quality TMF Document Timeliness Ensures that the TMF is complete and all required documents have been activated by their applicable due date. Certifies that documents are complete, indexed correctly, and scanned appropriately (if applicable) prior to activation in PTMF. Validates that documents are activated in PTMF within 35 calendar days of the document receipt date. 3 etmf QC controls Confirms that the In-line QC Process is in control and that documents are accurately QC d prior to activation. 9

10 Control plan and accountability Driving behavior Using highly visible metrics to ultimately improve quality outcomes Formal governance for management escalation Routine distribution of performance data to line management Real-time visibility in to TMF Slice & dice to see my TMF metrics Functional disciplines Geographies CROs Transparency in data to enable self-management by teams and document owner groups etmf as a database rather than an electronic filing cabinet 10

11 Monitoring the etmf process Report Summary 11

12 Health of the TMF Process Trending TMF completeness Past due/coming due based on study & site milestones Identifying studies in trouble Follow steady improvement QC defect analysis Document group/category Business process CRO/ strategic partner Business/functional line 12 12

13 Monitoring Trial Quality Example Trial Activity Quality Checkpoints Vendor oversight Monitoring Application of etmf metadata Document flow and etmf metadata (also CTMS data) do document deliverables indicating completion of key activities occur as planned/ expected? Documents in etmf & metadata to assess quality execution of activities (e.g. data management) Monitor CRO performance on TMF as well as executing other processes based on document delivery and etmf metadata Reports from previous visits in TMF prior to subsequent visits (in line with MHRA Grey Guide) Reporting from etmf can provide transparency and oversight in trial quality and execution 13 13

14 Health of Clinical Trial Processes Documentation (and its metadata) can provide insight into process execution and valuable feedback for process owners Completion is right documentation generated consistently by the process? Document quality does the process routinely generate quality documentation? Timeliness is the process documentation generated and handled in the appropriate timeframe? Does the pattern of documentation reveal complexity or confusion in the process or SOP? Execution of clinical trial processes result in documentation, and etmf metadata can help answer questions about clinical trial process 14 14

15 Questions 15