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

ASHLEY SMITH, LIFE SCIENCES SOLUTIONS, PROJECT MANAGER, TransPerfect- Trial Interactive: OCTOBER 23, 2013

AGENDA

  • Scope of Project

  • Initial Steps

  • Execution

  • Challenges & Resolution

Download Mid-Study Transition of a Global Study

Presentation

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
Download Mid-Study Transition of a Global Study