Activate Study

Summary

Once an agreement is fully executed for your research study or patient treatment, you can begin activating your study.

Study Activation Procedures

The process for activating a study varies widely from sponsor to sponsor. Your first step is to refer to your sponsor’s outlined procedures. Other steps may include:

Develop Standard Operating Procedures
Create Informed Consent
Undergo Affiliated Hospital review (e.g., University Hospital, Children’s Hospital, Parkland Hospital site review)
Create a plan on how you will enroll patients in the clinical trial
Ensure that the Coverage Analysis is complete, and the Agreement has been executed

Study Activation ClinCard Issues

Recently, the Internal Revenue Service (IRS) identified an issue where some study subjects participating in clinical research and utilizing ClinCard, contained name and Social Security information that did not match data on file with the IRS.

A mismatch can occur for a number of reasons, including data entry errors. In order to resolve this issue, the ClinCard system has been updated so that a participant's Social Security number and name must match according to IRS tax records. If there is not a match, the ClinCard system will automatically withhold 24% in taxes from each participant payment until such time as the correct data can be entered in the system. Again, this has to be done in order to comply with IRS tax regulations. The most recent TIN ID Mismatch file may be accessed here. Please ClinResClincard@utsouthwestern.edu the Clinical Trial Finance Team with any questions or issues.

Study Activation Contacts

Consult with the following departments for support and guidance in activating your study.

Terms and Definitions

Informed Consent: A patient’s voluntary agreement to participate in clinical research, based on their knowledge of the proposed clinical research.
Standard Operating Procedures: Guidelines compiled by a research team to help execute routine procedures.
Office of Clinical Research (OCR): Provides the infrastructure to support and promote clinical research, helping UT Southwestern advance the future of medicine.
Human Research Protection Program (HRPP): Responsible for ensuring that human-subject research is conducted by faculty, staff, or students for UT Southwestern in compliance with federal regulations.
UTSW Institutional Review Board (IRB): A review board that routinely examines research involving human subjects conducted at UT Southwestern or at an affiliated partner hospital.

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