CLINICAL RESEARCH INSTITUTE

Phone: (806) 743-4222 ● Suite BA 101

Submission Form for Industry-Sponsored Trials

This form must be completed and submitted to the CRI prior to any contract negotiations for Industry-Sponsored Trials

After completing this pre-proposal, print it off, have it signed by your chair and submit it to the CRI for review. You then will be contacted to set up an appointment to discuss the next step. If you need assistance, please contact the CRI at 743-4222, ext 221.

Name of Principal Investigator:
Position:
Department:
Phone:
E-mail:
Study Title:
Industry Sponsor:
Number of subjects & duration in study:
Inclusion Criteria:
Exclusion Criteria:
Explain how can you guarantee that the required number of subjects will be available and can be enrolled reasonably quickly?
Summarize the protocol and what is expected of subjects:
What will be expected of the nurse coordinator?
What will be the responsibilities of the Principal Investigator?
Does the Department agree to cover all expenses up front?
Would the Department prefer to pay for the hiring, training and full or partial salary of an additional CRI nurse coordinator?

INVESTIGATOR: By signing below, I certify that (1) the information submitted within this form is true, complete and accurate to the best of my knowledge and (2) I have completed the TTUHSC required training for clinical investigators. Date__________ Principal Investigator	DEPARTMENT CHAIR: I have reviewed the protocol for this application and find it consistent with college, department and TTUHSC policies and objectives. The Investigator has the skills and the department has the available resources (space, equipment, personnel) to support this program. Date__________ Department Chair
Date CRI Co-Director