Page 279 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q017
SOP Title: Pre-Trial Feasibility Assessment and RA Support of Research Project
4.2a. For studies that require support from Children’s RA, the PI typically reaches out to an RA coordinator for assistance with administrative and regulatory submissions.
4.2b. RA coordinator will apprise department team lead about researcher engagement and provide copies of study specific documentation (protocol, MOP, manuals, etc.).
RA Feasibility Coordinator Responsibilities
4.2c. RA Feasibility coordinator will be assigned to review project and determine the following:
• Reach out to the PI and provide him/her with a pre-trial feasibility questionnaire to complete;
• Following receipt of the pre-trial feasibility questionnaire, assess the patient population against the needs of the protocol. Work with Data Analytics and Informatics group to assess the patient population seen at Children’s Health with given disease profile;
• Review current active projects and determine whether there are any competing trials which may have an impact on the success of the new trial. Review historic trials and determine whether there were any conditions which had an impact on study success (i.e. recruitment concerns, etc.)
• Assess the protocol and identity institutional resources (i.e. IDS, Standard Review, Lab/Pathology, Radiology)
I. Investigational Drug Services – Clinical projects that utilize investigational drugs will need to have their protocol reviewed by IDS prior to initiation of the study. Researchers will be directed to IDSRx@Childrens.com and the following needs to be provided: the PI’s name, Velos #, STU #, along with a copy of the Protocol/pharmacy manual (if available)
II. 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.
III. Other Departments
• Reach out to each department and provide them with a copy of the protocol for review.
• Obtain Feedback from each supporting department within five business days
• Create a summary report for RA Administration
SOP No. 19, MM Draft 09242018