Department of Epidemiology and Biostatistics


Please complete Section 1 of this worksheet for each new study. By clicking 'Submit' the completed form will be emailed to ctrcprotocolsub@uthscsa.edu. If you do not have a username and password one will be assigned and emailed to you.

If you are an existing user log in to https://deb.uthscsa.edu/CTRCProtocol/Pages/entry.jsp, locate your study, complete the required sections and then click 'Submit to CDST' at the end of Minority Accrual Template. The completed form will be emailed to ctrcprotocolsub@uthscsa.edu, the PI and the CDST Leaders so the study can be scheduled for review by the Clinical Disease Site Team (CDST) and the Operations & Logistics Committee (O&L). If not already available, you may be asked for a copy of your protocol. Studies will not be considered for Protocol Review Committee (PRC) review without the completion of this form. O&L meets weekly as needed and will provide feedback as well as the committee's final decision to the PI and the Clinical Disease Site Team Leader. Trials approved by the O&L will be forwarded to the Protocol Review Committee for final approval. Submission to PRC may be concurrent to IRB pre-review, however IRB approval will not be granted without PRC approval.

For questions regarding O&L or PRC please contact Melissa Nashawati at (450-3955) or ctrcprotocolsub@uthscsa.edu. For questions regarding completion of the Minority Accrual template, developing materials in English and Spanish for IRB submission and scheduling public service announcements, please contact Monica Trevino at (450-1437) or MAtools@uthscsa.edu.



Protocol Tracking Basics - Section 1
* Date: Click to select date.  (mm/dd/yyyy)
* PI:
* PI Information:
* First Name:
Middle Name:
* Last Name:
* Credentials:
* Email:
* Are you the PI of the study?
* PI Designee:
* PI Designee Information:
* First Name:
Middle Name:
* Last Name:
* Department:
* Email:
* Phone Number:
* Official Protocol Title:
* Phase of Trial:
* Clinical Research Category:
* Primary Purpose:








* Clinical Disease Site Team:
Clinical Disease Site Team Leader:
* Disease Site:
(select all that apply)


* Name of Financial Sponsor:
(select all that apply)


* Study Source:
* Protocol ID:
* Is the protocol authored by a CTRC/Cancer Center Institutional PI?
* Does or will the CTRC/Cancer Center PI hold an IND or IDE?:
(check all that apply)
 
Preliminary Budget - Section 1 Continued
List sources of funding:
Amount of funding available:
Are there sufficient funds to support this trial (sponsored, cooperative group or IIS)?
If not, indicate how unfunded expenses will be paid for:
 
When section 1 is complete, check the box that follows the Cancer Center member agreement.

"By submitting this protocol, I agree, once this study is activated by the IRB, to timely add my subjects into the IDEAS database (if the study involves human subject research), and will adhere to the terms and conditions of Cancer Center membership, including Protocol Review Committee policies regarding accrual requirements as well as Cancer Center Data Safety Monitoring requirements."