Page 171 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-101
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5. 5.1
SOP Title: Clinical Research Essential Resource (CRER) Binder
Special taskforce who will oversee keeping all documents up to date, keep track of expiration date of documents, send out regularly scheduled notice to coordinators to provide updated documents and replace copies in the physical binder.
SPECIFIC PROCEDURE Maintenance Plan
The CRER (established June 2020) is located on Research Administration’s shared drive at the below referenced location, the aforementioned will be responsible for adhering to the outlined maintenance plan (section 5.1 of the current SOP). When utilizing the CRER binder, please follow the following steps: Access the RA shared drive and go to 2020 RESESARCH CREDENTIALS to locate the CRER electronic binders. An “Archives” folder will be in each research staff’s folder to store expired documents:
T:\CCS_RESEARCH\2022 RESESARCH CREDENTIALS
Establish Recurring Outlook appointments to review the Regulatory Maintenance Tracker with Special Task Force and TLs.
The Special Task Force will review the Regulatory Maintenance Tracker quarterly for expiry in the upcoming quarter.
a. Two coordinator(s)/associate(s) should be covering every quarter (a sign-up sheet will facilitate a rotating assignment). The assigned special task force members can switch amongst themselves.
b. The Special Task Force will send quarterly notifications to the respective coordinators for which expiry are identified for their assigned research staff (cc back-up CRC/A and TL).
c. When responsiveness is an issue, the Team Leads can facilitate and troubleshoot with the study personnel.
Primary coordinator or associate should respond to the notice of expiry and keep the CRER up to date and file the NTF in the respective sections of their regulatory binders as applicable (see below section and Appendices).
Upon completion of renewed documents, the coordinators should also update the Regulatory Maintenance Tracker with the respective expiration dates.
Inventory of updated documentation should also be taken at time of renewal and updated documentation filed accordingly across all of the studies in a coordinator’s or associate’s portfolio.
Maintenance Tracker
Here is the link to locate the maintenance tracker: Regulatory Document Maintenance Tracker 5.6.20.xlsx
For those PIs or Sub-Is who only have non-FDA regulated studies, please move them to the tab titled “Non-Regulated PI or Sub-I”.
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6. 7.
5.2
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