Page 34 - eBook Version 8 Book 1 of 2 JUL 2022
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Proposed Clinical Research Projects with Adult Patients at Children's Facilities
For clinical research studies with the intention of recruiting patients 19 years of age and older, the following checklist must be completed and reviewed by a committee of UTSW physicians and Children's leadership. The review committee will include the Principal Investigator and/or Division Chief, Medical Director of Children's Clinical Research, and relevant Children's leadership. This is an ad hoc committee that will meet to efficiently review proposed studies where Children's is the performance site and the studies intend to recruit adult patients.
Children's Health will only approve clinical research studies on patients 19 years of age and over, when those studies: 1. provide a therapeutic intervention that offer the prospect of direct benefit for the patient, Select a Response
. will recruit and treat patients who have an e isting or should have a treatment relationship Select a Response with a Children's Health program e.g., congenital heart defect program ,
Version Date 7/16/2021
. align with the clinical competencies of the Children's Health team members so that we will be able to provide the appropriate care, treatment and services,
. are part of a pediatric research study program e.g., Children's ncology roup study , are only awarded to pediatric institutions.
Select a Response Select a Response
Co plete the chec list below
Study ame:
Principal Investigator: Clinical location for the study:
IR umber:
1.What is the therapeutic relationship with the potential adult research participants and the Children's clinical area carrying out the research study Please check all that apply:
Current therapeutic relationship with the potential study sub ects Previous therapeutic relationship with the potential study sub ects
o therapeutic relationship with potential study sub ects
Therapeutic relationship will be established for the purpose of this study and continue after the end of the study.
Please e plain:
