Penn Medicine Clinical Research

Veeva Vault Clinical - Electronic Trial Master File (eTMF) for Sponsor Document Management*

*For Site side document management, please see Veeva SiteVault Enterprise

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
  • To function for any type of trial, be it single site or multiple sites over multiple countries. 
  • With organizational structure based on the cdisc Trial Master File Reference model. Refer to the Sponsor Trial Master File (TMF) section of this website for additional information.
  • 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. 

Penn Users:

  1. Complete the User Record eTMF RedCap
  2. 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”
  3. Penn IS will create training accounts as needed
  4. OCR will reach out to schedule training

Non-Penn Users:

Prior to the steps above, you must obtain a PennKey:

  1. Submit an external PennKey Request Form for a guest PennKey. 
  2. Follow steps for Penn users listed above

*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 User Record eTMF RedCapwill need to be submitted, and training completed prior to reactivation.

eTMF: Resources