Penn Medicine Clinical Research

Veeva Vault Clinical - Electronic Trial Master File (eTMF)

About

Vault Clinical or electronic Trial Master File (eTMF) is designed for the maintenance and storage of the essential documents for clinical trials as maintained by the sponsor. eTMF is designed to function for any type of trial, be it single site or multiple sites over multiple countries.  The eTMF organizational structure is based on the cdisc Trial Master File Reference model. The eTMF may be used for the storage of documents as well as the author, review, transmission of documents for e-signature and approval. Vault Clinical (eTMF) is built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records.

eTMF: Access & Training

eTMF is a validated system; each user requires training prior to being granted access.  All users, except for outside inspectors, must obtain a PennKey. Non-Penn faculty/staff can submit an external PennKey Request Form for a guest PennKey.  Access requires an Access Control Form to be completed.  Note that accounts are deactivated after 6 or more months of inactivity.  If you have switched job roles and/or departments, this could impact your access, and modifications to your account may be needed.  Should an account be deactivated, a new Access Control Form will need to be submitted, and training completed prior to reactivation.

  • Submit the form in a ticket in the PMACS helpdesk system if you have access (select the PennVault/Veeva queue), otherwise email the form to PennVaultVeeva@helpdesk.pmacs.upenn.edu with the subject line “eTMF access request”
  • Penn IS will create training accounts as needed
  • OCR will reach out to schedule training

Requesting nonuser person profiles

eTMF users: You may need to request new non-user profiles for staff who do not need access to the system, but you will need a person profile to link to their documents (ie: CVs, GCPs, trainings).  To create a non-user person profile (a record for someone who does not need to login to the system), follow the link here: etmf person loader.

eTMF: Resources

SVE: Support