Mid-Study Transition of a Global Study: Migration from Paper TMF to eTMF

• Scope of Project

• Initial Steps

• Execution

• Challenges & Resolution

CLIENT NARRATIVE

Client: Major Pharmaceutical Company conducting a Phase III study in 30 different countries

• Initially started using only one CRO as primary TMF holder
• Planned to expand to additional countries around the world
• Hired three additional CROs regionally
• Initiated the transfer of TMF during the study start up process

Site Activation

• Goal of 400 sites world wide
• At the point of transfer 120 sites were active within 30 countries

SCOPE OF PROJECT

Project Elements

• Timeline identified for documents to be received, indexed, and coded
• Approximate number of documents: 30,000
• Regions that will send docs to TransPerfect: APAC, EMEA, LA, US
• Transition from CRO TMF structure to TMF Reference Model
• Transition and train all CROs and Sponsor to new eTMF system and structure

INITIAL STEPS: TRAINING

• TransPerfect Staff
  • Sponsor
    • Partnering CROs
      • Internal Auditors

INITIAL STEPS: SET UP

• Set-up index structure and confirm specifications of metadata to be collected
  • Generation of configuration and mapping document
    • Generation of document transmittal form - Highlighting specification on document submission (wet ink, translation required)

INITIAL STEPS: TIMELINES

• Set timelines for receipt of paper documents, inventory, scan, upload and index of documents
  • Stagger timelines for site level versus central file documents
    • Generate document tracking reports to communicate transition progress

PROCESS EXECUTION

INDEXING

• Document transitional process of previous index structure to new index structure and share with client
• Mapping changes from the old index structure to the new

REPORTING

• Develop reporting mechanism for illegible documents and documents that need to be resubmitted
• Standardization of receipt documentation for multiple submitters

EXECUTION

• Track priority countries and priority site document
• Inventory, assign document ID, scan, and code document
• Streamlined indexing operation in the US and UK
• Streamlined coding process in India, US, and UK

EXECUTION: TIMELINE

• Documents received:
  • January: 6,572
  • February: 14,457
  • March: 24,018
  • April: 35,824

EXECUTION

• All documents coded and indexed by end of May 2013
• Initiate a reconciliation process with paper files to ensure accuracy and completeness of paper files
  • Reconciliation set to be complete by November 2013

CHALLENGES

• Multiple languages
  • Resolution: Translation
  • Upgrade: Inline translation of documents during coding process to increase efficiency
• Multiple changes to the index structure – the site file and country level filing structure
  • Resolution: File sign off on document mapping

SUMMARY

• Reduction in paper documents sent to eTMF
• Increased ability for reporting across all countries
• Increased visibility on study metrics