eTMF: A Five Year Vision

July 18, 2013

  • eTMF Resources

Recently, a client asked Wingspan to comment on how their eTMF processes and infrastructure might become more compliant, efficient and effective over a five year period. We thought that was a great question as it brings together technology, process improvements, and industry trends such as the increasingly virtual organizations, risk-based management, and more. Here is our assessment of some concrete milestones an organization adopting a leading-edge eTMF technology might hope to achieve:

Year 1:

  • Through the use of eTMF technology, planning and tracking the expected documents for each TMF becomes possible. Automation of a standardized, repeatable process allows greater harmonization across studies (resulting in decreased ramp-up time for users moving between studies).
  • Real-time metrics and reports provided by eTMF provide greatly increased insight into study completeness (resulting in greater compliance and audit readiness).
  • Partners such as CROs are using the system directly, decreasing the time delay and reducing the error rate in transferring documents.
  • The system is actively used to prepare for audits and ensure readiness.
  • Information is exchanged between eTMF and CTMS in real time, ensuring that eTMF is always aware as new sites and investigators come on board or milestone dates change.

Year 2:

  • Metrics and reports provide insight into specific quality issues that cause re-work, allowing root cause to be determined and addressed (increasing efficiency). Information is not confined to a single study, but can be used to pinpoint performance across studies related to specific scan centers, countries, types of documents, etc.
  • Metrics also allow the performance of partners (such as CROs) and business units within an organization to be monitored for quality and timeliness. Partners can be held to specific Service Level Agreements.
  • Study and site milestones are closely monitored, and are rarely delayed due to avoidable TMF-related factors.
  • Audit readiness is improved and preparation time decreased due to greater familiarity with how the system can be used proactively to prepare for and support the audit process.

Year 3:

  • Investigators/sites exchange documents directly with eTMF as a matter of course, reducing the burden on CRAs and ensuring that investigators always have up-to-date information.
  • The organization is comfortable allowing regulatory agencies to audit a study remotely.
  • A mature risked-based approach is applied to all aspects of TMF management, such as QC processes, study closeout, etc.

Year 4:

  • A full set of eClinical integrations is in place, allowing documents and data to be exchanged automatically with other systems. This is the culmination of a wave of integrations that began in Year 1 with CTMS, and provides greater compliance (due to always having up to date information), improved audit-readiness (due to all information being available in a single system) and increased efficiency (due to elimination of manual processes).

Year 5:

  • eTMF has developed into a well-oiled machine or factory, with highly predictable and repeatable processes.
  • Use of paper originals has been greatly decreased, and most documents either originate electronically or originate in paper but replaced by certified electronic copies.

Of course, the specific priorities of an organization might shift some of these milestones from one year to another. But I think most people would agree that having a system in place with all of these characteristics would place them at the leading edge of compliance, efficiency and innovation.