CRA training certificates of GCP and HSP in the TMF

[Amrita Bains]

Does the CRA (CRO staff) training certificates of GCP and HSP need to be filed in the TMF? Thank you.

[Janna Gonzalez]

Hi Amrita,
In my experience all key research personnel Qualification documentation are filed in TMF.

Qualification documents for PI and all key research personnel
• CITI Certifications (requirement is every 2 years)
• Medical licenses for physicians and nurses
• Current CVs for all study team members
• Study-specific training: Documentation of protocol review with study team, in-service
• Research-related training documentation
• Spanning duration of study or assignment to study
• Maybe maintained in a separate “credential binder(s)” with a documentation of where to locate this.
Janna

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