Filing Site-Specific SOPs

[Lindsay Grier]

Hi Everyone!

Does anyone have a specific spot they like to file site-specific SOPs? There doesn’t seem to be a designated place for them on the TMF Reference Model.

Thank you in advance for your suggestions!

[Marie-Christine Poisson-Carvajal]

We do not file site-specific SOPs in the sponsor TMF. They should remain at the site and be available upon request as part of site selection, or during an audit or an inspection.

[Darwin Thukkan]

Hi,

I agree with Marie. Site SOPs have to be at site only and we do not expect to file at sponsor TMF. List of SOPs reviewed during site selection or site initiation can be mentioned in Pre-Study Visit report or Site Initiation Visit report.

Thanks,
Darwin

[Jenn Leaning]

Hello,

For our organization, we maintain one TMF “set” per site to maintain site-level documents, so we could technically place the site-specific SOPs within 01.01.04 if the situation arises. Although I do agree with Marie and Darwin that the site should maintain all SOPs internally and not a regulatory requirement for Sponsors/CROs to collect, I have incidences where I’ve received site-specific SOPs before.

Example being: if the sponsor includes a “regulatory coordinator (not SC)” column in the DOA and requires that everyone on the DOA must have protocol training, but the site pushes back and proclaims that their site SOP specifies that regulatory coordinators are not required to receive protocol training, then we would request a copy of that SOP (or its section) so in the case the Sponsor gets audited, we have sufficient documentation to explain the reasons why.

But, it does make me wonder (for the situation I noted above): If an organization (Sponsor) does not collect site-specific SOPs for the TMF:
instead of requesting a copy of the site’s SOP, would it be better to have the site provide a memo for our records, or is it sufficient to have the CRA note in a MV Report the SOP# and reasons?

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