Page 146 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Site Initiation Visit Research Administration SOP No: R010 SOP Title: Site Initiation Visit
*ATTENTION: During time of Pandemic, our institution and department utilize a command structure to modify operations in accordance with the laws, CDC guidance, and within strict safety and regulatory compliance. Therefore, please follow the RA guidance in the Introduction of this book to observe the necessary precautions are taken in fulfillment of this standard operating procedure. All activates permitted under the current structure, should be 1) in line with the current guidance, 2) approved on a case by case basis as applicable (see Introduction RA guidance), and 3) adapted to virtual methods of completion whenever possible.
5.5 Procedure Process Map
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R010
10/01/20
Added Study Start-Up Checklist; updated process to define the UTSW regulatory team lead’s role; included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible.
R010
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