Page 278 - 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
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the process of completing a pre-trial feasibility assessment in order to determine whether Children’s Research Administration will provide resources and support for said trial.
2. INTRODUCTION
Prior to a clinical trial being initiated at Children’s Health, Research Administration (RA) will perform a pre-trial feasibility determination to assess the project scope and determine the following:
I. The principal investigator (PI) has performed a feasibility assessment of the patient population against the needs of the protocol;
II. Determined whether competing trials may mitigate a successful recruitment campaign;
III. Review historic projects of similar patient population and disease profiles in order to determine whether there were variables which negatively impacted project success and outcomes;
IV. Assess resource needs to determine whether support to initiate project is available from an institutional standpoint
Following review of the aforementioned; RA will inform the PI whether it can support the project to be performed at Children’s Health.
3. SCOPE
This SOP applies to all institutional researchers as well as collaborating partners (i.e. UTSW, TSHR, Andrew’s Center) conducting research at Children’s Health and requiring assistance from Children’s RA.
4. RESPONSIBILITIES
4.1 Children’s Health Research Administration – RA Feasibility Coordinator
To work with members of the research team following initial receipt of the study protocol and determine whether RA can fully support the conduct of clinical trial activities at Children’s Health.
Researcher Responsibilities
4.2 Researchers will need to adhere to department/institutional standard operating practice (SOP) and obtain appropriate department/institutional approvals following initial receipt of preliminary documents for a new clinical protocol. Depending on sponsor or funding agency, a confidentiality agreement may need to be executed prior to receipt of the study protocol. Moreover, department level and chairman approval may be needed before the project is green lighted for IRB and other regulatory submissions.
SOP No. 19, MM Draft 09242018