DESIGNING EFFICIENT PROCESSES FOR TMF CONTENT WHEN OUTSOURCING

DESIGNING EFFICIENT PROCESSES FOR TMF CONTENT WHEN OUTSOURCING

DESIGNING EFFICIENT PROCESSES FOR TMF CONTENT WHEN OUTSOURCING CLINICAL TRIALS Lisa Mulcahy Mulcahy Consulting, LLC LISA MULCAHY Lisa Mulca hy has a 23-year professiona l career in the Pharmaceutica l Resea rch industry. Content and Records Management independent consulta nt, particularly in the area of the trial master file. She is

skilled in the assessment of client's content and records mana gement TMF processes and programs; advising on area s for im provement a nd proposing future strategic direction ensuring ICH GCP a nd regulatory complia nce. Mulcahyconsulti [email protected] She has worked closely with numerous la rge and small companies providing consultative meetings through to providing an in-depth ana lysis of the current sta te of a ffairs, assisting them in the planning their future sta te of excellence. She works with clients as they embark on the electronic crea tion, management, a nd archiva l of electronic TMF content. Co -leader of the TMF RM Tea m. THE TECHNOLOGY V. THE PROCESS

Much of the way that the content in Trial Master File is collected, created, and managed is contrary to our normal everyday way of thinking and working. Consumer rewards cards that connect personal data with usage and purchase data. We like getting something for doing nothing. Phones allow us to do banking transactions; including photos to deposit checks. Enroll subjects into clinical studies using interactive web technology THE TECHNOLOGY V. THE PROCESS For TMF collection, creation, and management many of us are still working in the = THE OLD TMF PAPER-BASED

PROCESS SPONSOR TO CRO OR SITE EE PP PP PP BEGIN HERE Up to 11 Steps! TMF at CRO or ISF at Site

TMF at CRO or ISF at Site END HERE REDESIGN RETHINK PROCESS Redesign Rethink processes to enable sponsors, CROs, and sites to create and contribute efficiently to the TMF -without paper or email attachments Create Review - Approval Collect Submit - Report Distribute - Consume Acknowledge HOW EASY CAN IT BE?

USING TECHNOLOGY TO ITS FULLEST SITES eTMF PORTAL SPONSO R CRO / VENDOR S The technology is already available and will continue to advance Rethink the Process SO WHATS HOLDING US BACK?

OURSELVES! QUICK & EASY TARGETS Eliminate common, costly, and time-consuming pain points Define the full list of TMF content. Use TMF RM to align with industry why be different? Evaluate each individually. Define purpose, usage/consumption Define movement through lifecycle

Ask whether data entered from templates could replace any document Use templates to create content directly within eTMF system. BEGIN HERE Auto-populate content metadata during creation QUICK & EASY TARGET: SIGNATURES Reduce internal signature requirements Only7 required per the ICH Guidelines Break ingrained habits. Is a signature

required to establish accountability? Audit trials are functionally equivalent automatically capture name, date, time If signatures are absolutely necessary, replace wet-ink with electronic Nearly all regulations accept e-signatures Quicker document approval process QUICK & EASY TARGET: SIGNATURES TMF CONTENT SIGNATURE REQUIRED? TMF CONTENT SIGNATURE REQUIRED? Notification to Investigators of

Safety Information Protocol signature page (Sponsor and Investigator) Regulatory Submission Contract with Site Monitoring Visit Report Contract with Vendors Dose Escalation Documentation Case Report Forms Trial Management Plan

Regulatory Required Form (ex. Form IRB/IEC Approval Informed Consent FDA 1572) Required by ICH Guidelines Which ones can be signed electronically? ALL ! QUICK & EASY TARGET: SCANNING

EE PP Stop scanning electronically created documents manage them electronically Cost of inefficient resource utilization v. implementation of an 21CFRP11 compliant repository such as eTMF If you have to scan, rethink the process document by document Does every document HAVE to be scanned? Ex. How many people are actually using scanned site feasibility documentation

again after collection?? QUICK & EASY TARGET: EMAIL Cut use of email and unofficial collaboration sites as document exchange vehicles. Establish process to exchange TMF content and electronic signature with CROs, vendors, and investigative sites electronically Use cloud-based eTMF with or without validated portal linked to eTMF PP QUICK & EASY TARGET: SHIPPING Stop sending paper TMF content by air $$$ to pay for transport $$$ and time for preparers to prepare

$$$ and time for receivers to receive ROI easily calculated if transport PP costs are replaced with the send button within an eTMF system or portal 50 sites X 10 shipments/year $20 per shipment= $10K in transport costs Easily scalable TMF at CRO or ISF at Site WHAT COULD ONE RETHOUGHT PROCESS LOOK LIKE? Rethink how a typically paper TMF document with a wet-ink signature component could be created and

finalized? The Clinical Trial Agreement - critical to timelines SITES SPONSO R CRO As-Is Process EE Negotiation Creation SITES CRO

PP CRO Wet-ink Signature SPONSO R HOW EASY CAN IT BE? USING TECHNOLOGY TO ITS FULLEST SITES eTMF PORTAL SPONSO

R CRO / VENDOR S Rethinking processes in which sponsors, CROs, and investigators contribute directly to the TMF WHAT COULD ANOTHER RETHOUGHT PROCESS LOOK LIKE? Rethink TMF content in terms of data sets The creation, collection, distribution of TMF content (data) would focus on the information exchanged and not doc creation/collection Assessing completeness of data instead of document presence Consider this investigators enter

financial information in a database through an investigator portal. extrac Financial status report. t Replace a wet-ink signed form. Easier and significantly less time and $ resource intensive than collecting and tracking forms. CRITICAL STEPS OBSTACLES TO AVOID

1 . Company culture cannot be allowed to define the way you rethink your TMF management process. Help your company to break through their old ways of thinking to do some groundbreaking process work CRITICAL STEPS OBSTACLES TO AVOID

Technology cannot provide the process. Technology supports the process 2 . CRITICAL STEPS OBSTACLES TO AVOID Engage the consumers of the TMF content when you rethink your process at the sponsor, the CRO, and the investigative site. What do they actually need? 3 .

Like the electronic FDF, consumers might only need dataand not a document. PI/SI SPONSOR CRA IN SUMMARY The technology to collect, create, manage, and exchange efficiently is here and evolving rapidly We must now rethink the human TMF management processes to best leverage the technology THANK YOU To Veeva for the opportunity they

have given me to be here with you today To you for being here and being so engaged Contact info: [email protected]

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