Page 240 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q018
SOP Title: Assessing & Requesting Ancillary Service Support
c. Standard Review – Clinical projects that utilize technologies provided by the study sponsor on loan and connect to Children’s network for the transmission of data to the sponsor or third party will need to have a Standard Review assessment. Other qualifying scenarios include the following: (1) any software which the sponsor directs the local researcher to download on a Children’s issued computer (desktop/laptop/portable device); (2) Any medical device (investigational or FDA approved) that is not being used in the Children’s environment.
2. QS team member will follow steps as outlined in SOP #5 and will send an introductory e-mail with a list of requests to the PI/PRC at the time of IRB submission.
6. PROCESS MAP
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q018
04/01/202 1
Removed reference to Advanced Analytics requests since Kita has developed a new SOP that explains this process in greater detail.
17
SOP No. 17, 12-21-2018; 04-03-2020; 02-17-2021