Department of Epidemiology and Biostatistics


Please complete Section 1 of the Protocol Information Extract Summary (PIES) for each new Cancer related protocol. By clicking 'Submit' the completed form will be emailed to ctrccto@uthscsa.edu and ctrcprotocolsub@uthscsa.edu . PIES information will be populated into Velos eResearch (Velos). Please also email a copy of your protocol to these same two email addresses so that your protocol can be reviewed by the CTRC Clinical Trials Office (CTO) and the CTRC committees as required by the CTRC Protocol Review and Monitoring System - Studies will not be considered for the Protocol Review Committee (PRC) review without the completion of this form, completion of the New Protocol Submission Form in Velos by the Principal Investigator and approvals by Clinical Disease Site Team, the Operations and Logistics Committee and Clinical Research Oversight Committee. IRB approval will not be granted without PRC approval. Institutional approval will not be granted without the completion of coverage analysis and documentation in Velos which will be completed and submitted on your behalf by the CTRC CTO.

For questions regarding the CTRC Cancer Committees, please contact Melissa Nashawati at (450-3955) or ctrcprotocolsub@uthscsa.edu . For questions regarding the CTO, please contact Kayla Jackson at (450-3824) or Kim Markosfeld at (450-1018).



PIES - Section 1
* Date: Click to select date.  (mm/dd/yyyy)
* PI:
* PI Information:
* First Name:
Middle Name:
* Last Name:
* Credentials:
* Email:
* Study Entered By:
* Study Entered By Info:
* First Name:
Middle Name:
* Last Name:
* Department:
* Email:
* Phone Number:
* Study Coordinator:
* Regulatory Contact:
* Data Manager:
* Official Protocol Title:
* Objective:
* Summary:
NCI Trial Identifier:
NCT Number:
* Keywords:
Agent Device:
Study Linked To:
* Phase of Trial:
* Clinical Research Category:
* Clinical Disease Site Team:
Clinical Disease Site Team Leader:
* Disease Site:

* Total National Sample Size:
* Total Local Sample Size:
* Study Duration:   
* Estimated Begin Date:    Click to select date.  (mm/dd/yyyy)
* Name of Financial Sponsor:
(select all that apply)


Sponsor ID:
NIH Grant Information:
* NIH Grant Info Details:
* Funding Mechanism:
* Institute Code:
* Serial Number:
* NCI Division/Program Code:
* Study Scope:
* 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)
CTRP Reportable?
FDA Regulated Study?
 
Agreement
 
When this form 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 VELOS 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."