Health Authority Submissions Made by CROs

[Dee DeOliveira]

Hello,

Currently having a debate about the TMF location for archival of health authority submissions (i.e. CTAs and Amendments) that are made by CROs. Typically I have seen these documents kept in the regulatory system and referenced accordingly in the TMF Map however some believe they belong directly in the eTMF. Curious about what others have done and any insights.

Thank you

[Allison Grosik]

Hi Dee,

From my experience, Health Authority submission documents generated by the CRO (e.g. CTAs, substantial amendment notification forms, cover letters, etc)
are filed in the study eTMF. CROs usually do not have access to file directly into the Sponsor regulatory system.

I have seen Sponsors file regulatory documents directly in their internal system for only those countries where they hold submission responsibility. This is common for USA FDA.

Best regards,
Allison Grosik
LMK Clinical Research Consulting

[Eldin Rammell]

Hi Dee,

Where I’ve seen some differences is between filing of submissions versus approvals. Often, the full submission is filed in the regulatory system but only the documentary evidence of approval is filed in the TMF. It is essential the TMF Index identified which system both documents are filed in.

Eldin.

[Dee DeOliveira]

Thank you both for your response. This is helpful.

Best regards,
Dee

[Author]

Posts