Steps for Starting a Research Project
Planning for the Study
While research cannot begin before approval of the NR3, it is necessary to begin planning for the study in advance. This should include working with departments that will be involved in the study.
Credentialing:
The PI must have Children's Medical Staff privileges, be a Children's employee, or be a Fellow / Resident or Medical Student at UT Southwestern. If the PI is not a member of the Children's Medical Staff, a faculty sponsor who is on the Medical Staff is required.
There are non-research Children's credentialing requirements that need to be completed before accessing PHI (Patient Health Information) or having patient contact, for non-employees.
Please contact Children's Medical Staff Services main number (214) 456-1824
For student credentialing please contact Graduate Medical Education main number (214) 456-2735
Training:
Training Requirements for Research Personnel
- Children's Research Training Program:
Research Compliance: Children's Medical Center As A Performance Site
Research Compliance: Overview, Roles & Responsibilities
IRB and HIPAA Research Training:
IRB, HIPAA, HSP & GCP Trainings
To verify that all research training requirements have been met, call (214) 456-6220.
Personnel support:
To request research study personnel support from Children's Clinical Research Department, complete and submit the
Research Support Request Justification Form.
Evidence Based Practice (EBP)
Evidence Based Practice research initiatives require approval of the EBP Council prior to submission to the IRB. Please reference Clinical Practice Policy 7.01 or visit the EBP Webpage.
Create Budget
The Research Department should be your only source for obtaining research pricing. Prices obtained elsewhere may not be accurate.
The Research Department can either:
prepare a comprehensive budget for your study
provide pricing and other support for you to prepare the budget yourself
Contact Research.Finance@childrens.com for assistance with developing the budget for services at Children's.
In the preparation of a study budget, the Research Department will need a detailed report of the following:
all procedures
labs and medications to be used, specifying which are standard care and which are research only
Children's personnel involved in the study, including the study coordinator (if applicable)
Procedures performed at Children's
Special services
Supplies
Clinic visits
Equipment
Mixing of drugs
Patient stipends or gift cards
After final budget approval from the Children's Research Department, send the budget to the Research and Grants Office at UTSW.
Once funding is in place, the Research Department will work with UTSW to have a service order (contract) established.
Obtain IRB Approval
Submit to IRB for review and approval Click here
UTSW IRB approval, while required, does not constitute approval to begin the research study at Children's.
Approval from Children's
Checklist for NR3 submission review
Complete the NR3 form via UTSW ERGO
Once the NR3 is approved and signed by the Medical Director of Research, a research account will be opened, if applicable.
Confirm Execution of Contract Prior to Trial Initiation
Contact MaryAnn Byerly (214) 456-1856:
if you have not received your research account number
if you need to obtain patient stipend vouchers or gift cards
Plan logistics with the lab:
Once you have your research account, contact Amanda Richards (214) 456-2612.
Investigational Drug Service:
Contact Ruth Merryman (214) 456-2924 to ensure that everything is in place for the study.
Contact Radiology if any Radiologic procedures will be required.
Obtaining patient records for retrospective chart reviews or screening / recruitment activities:
Guidelines for Obtaining Protected Health Information and Request for Medical Record Search
Inservice participating staff:
Communicate with departments involved including medical directors and clinical managers at any site where study participants will be seen
