Trial Master File Access Frequently Asked Questions

There is a new team member who needs access to the DAIDS TMF. Who should I contact?

Send an email request to the DAIDS TMF Team NIAIDDAIDSTMF@mail.nih.gov.  Your request should include your new team member's: 

  • Name
  • Email address 
  • Study role (e.g., DAIDS TRP/PSP MO, OCSO PO/COR/MOB, or delegate uploading on behalf of an MO etc.,) 
  • List of DAIDS approved electronic systems that they will need to access
  • The purpose/reason for needing access to the system 
  • List of protocol specific TMFs that they will need to access

 

Do I need to take training to access an approved DAIDS electronic system?

Yes, every electronic system has access requirements that you must complete to be granted access to an electronic system. 

After I complete the required trainings provided by the approved DAIDS Electronic System Owner (ESO), when can I expect access to their system(s)? 

Access will be provided within 7-10 business days after completion of training, per electronic system owner procedures.

How do I keep my access active to an approved DAIDS electronic systems?

Please consult the training and reference materials provided by the electronic system owner. 

I need to reset my password to an approved electronic system. Who should I contact?

Contact the ESO.  The DAIDS TMF Electronic System Contact Listing - PDF contains the contact information for each electronic system. 

A new DAIDS Primary Contact (PC) will be taking over my role and responsibilities when I retire. How should we go about giving them access to the same electronic systems I had and when should we do it?

Provide written notice to the DAIDS TMF Team. At minimum, the notification needs to: 

  • specify effective dates for onboarding and retirement
  • outline specific roles or responsibilities that will be impacted
  • identify electronic systems and studies that will be impacted

How are DAIDS PCs granted access to a TMF after initiation?  

The DAIDS TMF Team will inform the ESOs of the specific DAIDS PCs that need access to an electronic system for a TMF within 30 business days of TMF initiation.

I am not a DAIDS PC, but I upload documents to a TMF as an Authoritative Source. How am I granted access to a TMF after initiation? 

Please contact DAIDS TMF Team at NIAIDDAIDSTMF@mail.nih.gov to get access to submit documents. 

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