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Investigator-Initiated Studies

These forms can be completed on line by clicking on the appropriate box or typing the information in the text box using Microsoft Word. The text boxes are deliberately set up with a limitation on the number of characters (and, hence, words) that can be entered. Entries should be concise and to the point. The applicant may contact members of the CRI staff for assistance at any stage in the process.

When you have completed the application, print it off, sign it, have your chair sign it if requested and send it together with the other forms requested by Campus Mail to the Clinical Research Institute, Stop 8183 or bring it to the Institute in Suite BA-101. We will contact you about the next step as quickly as possible. Most applications will be reviewed by members of the CRI staff, but some may be submitted to the Advisory Committee for their recommendations.

Instructions for specific forms:

CRI Route Sheet: Please complete this form and have it signed by the Principal Investigator and Department Chair for all studies you wish the CRI to assist you with, including retrospective chart reviews. Submit this completed form along with a copy of your protocol and data collection sheet to the CRI. A member of the CRI will contact you after reviewing your documents. A protocol template is available on our website for your use if you need it.  CRI Route Sheet

Protocol Template for a Human Research Study: This is the same form to be submitted to the IRB. Use of this form is not mandatory but saves a step and helps to ensure IRB approval. Note that a copy of the Consent Form (available in iRIS) and the CRFs must also be submitted.  Protocol Template

Amendment Form: The purpose of this form is to assist you and/or the Clinical Research Institute in preparing the IRB submission of the Protocol amendment. Use this form to develop your ideas prior to a submission. Amendment Form

Application form for Industry-Sponsored: This form must be signed by the chair, submitted and approved by the CRI prior to any negotiations with the sponsor on the budget and the contract being started. Note the additional two forms list below that also must be completed for Industry-Sponsored trials.  Application form for Industry-Sponsored Projects

Contract Routing Form: This form must be completed and attached to all Industry-Sponsored Clinical Trials Agreements submitted for signature and execution. This form must be signed by the Principal Investigator, his/her Chair and all sub-investigators.  Contract Routing Form

Financial Disclosure Form: This form can be obtained from the Office of Research Integrity link, and must be completed and submitted to them before any research can be started under a grant or a contract.  Financial Disclosure Form

Application Form for Medical Students: volunteering to assist in clinical research. Complete this form online and submit it to the e-mail provided on the form.  Student Volunteer Form

Semi-Annual Report Form: This form must be completed by the Principal Investigator. This report form must be completed every June and December and submitted to the CRI for Semi-Annual review.  Semi-Annual Report Form

Investigator Responsiblities: Protecting the rights, safety, and welfare of study subjects.  FDA Guidance on Investigator Responsibilities

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