Page 68 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Site Evaluation Visit Research Administration SOP No: R005 SOP Title: Site Evaluation Visit
5.2.2 Provide copies of relevant, appropriate study-related materials (i.e., copy of protocol and study visit schedule) to all meeting attendees prior to the pre-study evaluation visit.
5.2.3 Provide the sponsor with:
5.2.4 Documentation of the local clinical laboratory current licensure or accreditation, along with current normal reference ranges for applicable tests.
5.2.5 Current copies of clinical site research personnel’s curriculum vitae (as required by sponsor).
5.2.6 Other certifications and/or training (e.g., International Air Transport Association (IATA) training, dry ice certification, etc.).
5.2.7 Information specific as to how research activities are conducted at the site, including the responsibilities of clinical site research personnel.
5.2.8 Institutional Review Board (IRB) requirements and scheduled meeting dates.
6. PROCEDURE PROCESS MAP
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R005
04/01/21
Added COVID precaution language
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