Trial Master File (eTMF) / Investigator Site File (eISF) module is an integrated tool to manage all study documents and other digital content in one place.

eISF part is intended for investigational sites to have access to all applicable study documents, upload documents and receive updates.

eTMF / eISF module is not merely a document repository, but an effective tool to increase real-time inspection readiness starting from the creation of a document for Sponsors and sites.

Direct connection to site files reduces the number of missing documents through access that enables more frequent remote inspections. A systematic process for collecting essential site documents, reporting, and alerts on missing documents and expiry dates assist with identifying study-jeopardizing compliance errors. Clinical operations team can see site workflows based on specific protocol needs, identify possible issues to progress in real time, and obtain documents and data between site visits.

With this integrated eTMF / eISF there is no need for CRAs to rely on sending essential documents in emails or waiting until next site visit to file documents manually. Study team can upload documents to eTMF and all eISFs regardless their geographies within a couple of seconds. It is necessary to upload a document just once because documents flow seamlessly between eTMF and eISF section.

Study progress is accelerated by allowing real-time insights and access to eISF that was historically only attainable through site visits when CRAs could check paper ISF.

Electronic ISF provides the ability to conduct remote site monitoring, recommended by the FDA and EMA, helps CRAs work more efficiently in today's increasingly virtual environment caused by COVID-19 while reducing travel expenses and travel time.

The module includes study level, country level, site level, study personnel level for relevant documents. For example, study level section includes study specific documents: essential documents and master versions of documents, study plans, study reports, tc minutes, etc.

Country specific section will include country specific documents related to the study: regulatory documents, EC documents, local vendor documents, etc.

Site section includes site specific documents: LEC documents, site feasibility questionnaire, monitoring visits report, follow up letters, site staff trainings, logs, license, accreditations, etc

Personnel specific section will include investigational team member documents: Data Privacy Agreement, FDF, diplomas, certificates, CVs, Protocol/IB signature pages, etc.

The features of the module include:

  • Inbuilt eTMF and eISF index
  • Configurable eTMF/eISF structure
  • Go-to-Green navigation technology
  • Multilanguage interface – use of different languages in the same trial
  • Information on author, review, approval, approval date, version, date, expiry date
  • Batch documents upload to study and site level sections
  • Ability to send updated documents to all sites at once
  • Receipt confirmation of documents by site proven by electronic signature
  • Real-time statistics on folders completeness
  • Adjustable notifications based on subscriptions to folders
  • Document upload, auto-classification, auto-naming
  • Document download
  • Live tracking of missing and expired documents
  • Document expiry date control
  • Quick and short training of the system
  • Regulatory Inspection Ready
  • Alerts via emails and color alerts in the system