Where to file evidence of Medical Monitor Involvement

[Jane Marie Johnson]

Good morning,
During an audit we were asked to provide evidence of medical monitor involvement. Initially we provided a log showing MM reivew (assessment, signature and date); however we were asked for additional evidence such as meeting invites and meeting minutes. These were filed in general correspondence and it took time to locate. Would you suggest filing these with the plan?
01.01.09 Medical Monitoring Plan
To describe how medical surveillance of trial subjects will be assured during the trial. Artifact can include any evidence of plan execution including, but not limited to: plan, reports, checklists, etc.

Or in
01.05.01 Relevant Communications Correspondence
Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but are not limited to: letters, memo, electronic communications and faxes. Correspondence referring to general topics and/or topics across multiple zones may be filed with this zone

Thanks!

[Janna Gonzalez]

Hi Jane,

I think you should filed in Zone 01.05.03.

Agenda, presentation materials and other documentation generated during any other internal or external zone-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.

If your tracking these documents-
Pre-Organizational Meeting Agenda
Start Up Meeting Minutes, Action Items, Meeting Minutes Monitoring Plan ” -Meaningful date- Meeting Date.

Other Meeting Material-Internal
or Other Meeting Material_External (if applicable)

Hope this helps!

Janna

[Author]

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