Study Submission
The Office of Research Administration (ORA) requires a complete submission packet with the following documents for the study to be accepted and reviewed:
Drugs or Device Studies
- Performance Site Review Report*
- Final study protocol
- FDA letter re: IND or IDE exemption
- e-IRB application
- IRB approval letter
- Informed consent document
- HIPAA or Waiver of Authorization
- Coverage Analysis Determination | Clinical Trial Coverage Analysis (CTCA)
- Investigator Brochure or sponsor device description
- All applicable agreements and/or contracts must be executed (Note: If industry-sponsored, a Letter of Indemnification or Facility Use Agreement is required)
*For UTSW-affiliated studies only.
Chart Review/Data Studies
- Performance Site Review Report*
- Completed Parkland Research Data Form
- Final study protocol or project summary
- e-IRB application
- IRB approval letter
- Informed consent document, if applicable
- HIPAA or Waiver of Authorization
- Coverage Analysis Determination | Clinical Trial Coverage Analysis (CTCA), if tests or procedures are done as part of the study
- All applicable agreements and/or contracts must be executed
*For UTSW-affiliated studies only.
Learn more about Data Services for research.
The assigned ORA Analyst will work directly with the Study Team as a part of this process. For additional assistance, email ResearchBilling@phhs.org.