etmf structure, setup, and implementation case study

A Case Study of an eTMF Implementationat a Small Biotech

Adair Turner, MSc, RACRegulatory Affairs ManagerMission3, Inc.

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Disclaimer

2www.diahome.orgDrug Information Association

• This session provides a case study of an eTMF implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.

• We will discuss our experience, process management, and lessons learned.

Agenda

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• Not enough resources!• The logistics of managing

paper-based processes with limited resources was challenging, overwhelming, and time consuming.

• Documentation was inconsistent, incomplete, missing, expired, and/or redundant.

Problem


“Welcome aboard, Bob. Your job is to figure out what the heck happened here.”

• Prepare for an upcoming NDA eCTD submission and the subsequent GCP inspection.

• Transform existing paper based processes with a centralized electronic solution that would maximize resources by using a globally available cloud-based framework.

Objective


• DIA TMF Reference Model utilization– Clearly structured to account for documentation levels

and the trial complexity (global, country, site)– The TMF RM is intended to provide a collaborative

advantage to stakeholders in creating and managing their TMFs.

Partner’s System Requirements


• Software as a Service delivery model in which software and associated data are centrally hosted in the cloud and available globally

• Low cost and commitment• Quickly and easily implemented• Document management capabilities

– Check in/check out, version control, audit trail, work flows and lifecycles, etc.

– Ability to use the same system for multiple projects

• Flexible• Minimal validation required

Additional Requirements


Program Plan - 5 Projects


1. eTMF Structure, Setup, and Implementation

2. Ongoing Clinical Trial Document Processing

3. Legacy Clinical Trial Data Processing

4. EDM Regulatory Structure, Setup, and Implementation

5. NDA Project Planning and eCTD Document Processing

eTMF Solution


Together, we developed a flexible process:

Process Definition


Technology Setup – 5 months

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The Process - Partner


• CRA receives paper document(s) at site, identifies/verifies content, completes online transmittal form, assembles document package, and ships document package to Scanning Vendor

Scanning Vendor Process


eTMF Vendor Process


eTMF Vendor QC Checklist


Verify:

•Page count

•Naming convention

•Metadata

•Location

• Partner audited both the Scanning Vendor and the eTMF Vendor to ensure appropriate quality documentation prior to signing.

• SOPs/Methodologies/Working Practices for Scanning vendor, eTMF vendor, and Partner company that cover each part of the process

• Appropriate and documented training• Validation documentation

Documentation


• Partner went through the DIA TMF RM and added the naming convention they wanted for each item.

Document Naming Convention


• Beyond the metadata suggested by the DIA TMF RM, we added a field for the unique “Physical Document Locator” that corresponds to the hard copy and wet signature if needed.

Metadata


Current Study


• We used the current Ph. 3 study as our initial project and pilot.

• Together, we wrote, reviewed, and implemented Scanning Methodology and Work Practice documents.

• Scanned, indexed, and filed approximately 3500 documents in 6 months.

• Implemented EDMS for Regulatory documents during this timeframe as well.

• More than 60,000 legacy documents were shipped to scanning vendor (in 80 boxes).

• The shipment included a MS Excel spreadsheet that listed the documents that were in the boxes and was organized by section of a previous Trial Master File and by folder identifier.

• A new methodology document was written for scanning the legacy documents.

Legacy Process


• The Scanning Vendor had to do a great deal of document reconciliation in order to index and scan the documents and timelines were pushed back by a couple of months.

• Legacy Study #1 contains approximately 26,500 documents and must be complete in 2 months!

• In order to meet timelines, documents must be reviewed and filed in under 1 min each.

• A weekly status report is provided to our partner showing the status of planned completion vs. actual completion.

Legacy Study


• Scanning vendor indexed documents with metadata provided on the Excel spreadsheet.

• Text file indexes are uploaded with the PDF documents to a secure SFTP site.

• The text file is used to populate the document metadata as the documents are automatically loaded into a “Staging Area.”

Automated Metadata


Legacy Document Transfer


• All study records are globally accessible, available and organized. Partner is able to easily identify gaps and assess completeness.

• New processes, standards and controls ensure increased TMF quality.

• Time associated with file requests, audits, and inspections have decreased. While the cost of mailing documents, searching for information and reproducing redundant documentation is significantly lowered.

How is it better?

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• Establish paper document classification.

• Identify document naming conventions and metadata early.

• Correspondence should be relevant and organized.

• Planning and communication are the keys to estimating and managing program timelines.

Lessons Learned



Let me know if you have any questions!

[email protected]

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