I recently co-presented a webcast on increasing study efficiency through the use of technology with my colleague, Crista Casey.

We received several questions related to maintaining compliance for the preparation and storage of Study Documents while managing trials via a digital eClinical platform.  As such, I wanted to provide additional background as it relates this blog post.

Clinipace’s proprietary eClinical platform, TEMPO™, is deployed as part of a validated system that complies with and follows:

  • GCP predicate rule requirements, laws, and regulations for clinical trial conduct
  • FDA 21 CFR 11 for electronic record and signature use
  • Drug Information Association Reference Model 2.0 for the eTMF

In addition, TEMPO currently supports and complies with the following Clinical Data Interchange Standards Consortium (CDISC) standards:

  • Operational Data Model (ODM)
  • Study Data Tabulation Model (SDTM)
  • Study Design Model in XML (SDM-XML)

All paper or electronic documentation is prepared, scanned, described, stored and centralized in the TEMPO™ Trial Manager where it is then available for role-based searching, viewing and tracking.

When original/source documents are transferred to electronic format – the transfer should be validated and/or certified. The transfer process should also be delineated in standard operating procedures and be agreed to in sponsor agreements.  We highly recommend critical documents (e.g. contracts, consent forms, FDA form 1572) be retained as well as original documents with wet ink signatures by the site, digital CRO or Sponsor as applicable.