Page 170 - eBook Version 8 Book 1 of 2 JUL 2022

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PURPOSE
STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-101
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The purpose of this standard operating procedure (SOP) is to define the procedure for describing the process, purpose, and identify who is responsible for maintaining the clinical research essential resource binder.
INTRODUCTION
This is in line with our institution(s) strategic priorities of quality and efficiency, research administration (RA) has integrated a centralized electronic and physical process that incorporates clinical research essential materials. The clinical research essential resource (CRER) binder is to improve efficiency, quality and will help to achieve Children’s Health operation margin by reducing the cost associated with buying paper and with printing essential documents required for study management for the studies currently managed by the Medical/Surgical/Heart Centers. At a minimum the CRER binder will include Principal Investigator (PI) and Sub Investigator (Sub-I) CV’s, professional licenses and research training completion (CITI, Children’s Cornerstone modules). Additionally, the binder will include the requisite laboratory and pharmacy documentation and materials to fulfil departmental guidance and the regulations regarding essential documents. The PI e-binder will be in the Research Administration shared drive. A hard copy binder will also be established containing the same information as the electronic binder, for monitor use during site visits.
SCOPE
This SOP applies to all research coordinators, associates, team leads in Medical/Surgical/Heart Centers, physicians, and any other person(s) listed on the delegation of authority log.
RESPONSIBILITIES
All those who conduct research at Children’s Health are ultimately responsible for PI delegated tasks in partial fulfilment of good clinical practice (GCP) and relevant governing regulations and policies. As it relates more specifically to the current CRER resource, coordinators are responsible for the actualization and maintenance of the CRER and following the current maintenance plan to ensure regulatory compliance.
CRER Requirements:
a. The PI e-binder will be in the Research Administration (RA) shared drive.
b. At a minimum the CRER binder will include Principal Investigator CV’s,
professional licenses and research training completion (CITI, Children’s
Cornerstone modules).
c. The binder will include the requisite laboratory and pharmacy documentation
and materials to fulfil departmental guidance and the regulations regarding essential documents.
d. Access the RA shared drive and go to 2020 RESESARCH CREDENTIALS to locate the CRER electronic binders. This is where the PI’s, Sub-I’s, research coordinator’s, research associates’, IDS, and TL’s essential documents will be stored electronically.
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SOP Title: Clinical Research Essential Resource (CRER) Binder