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BioMed knows that many research coordinators want to try drafting and preparing what to submit ahead of time. You are invited to contact us for forms, but frequently used forms are provided below.

The following forms are in Microsoft Word format. To use these forms, you need to have MS Word version 97 or higher installed on your computer.

To download a form, right-click on the document you want and select Save Target As. Save the document to your desktop before editing your information electronically on the computer.

BIOMED IRB Statement of Compliance  Explanation of the FDA/NIH template for Clinical Trial Protocols  FDA/NIH Template for Clinical Trial Protocols New Study Submittal Application - Principal Investigator New Study Submittal Application - Sponsor / CRO Device Study Application Research Site Questionnaire Serious Adverse Event (SAE) Reporting Form Protocol Deviation/Violation Reporting Form Unanticipated Problem Involving Risk to Subjects or Others Reporting Serious Adverse Events / Effects and Unanticipated Problems Involving Risk to Subjects or Others Guidance for Reviewing Recruitment Materials Downloading and printing instructions

 

Once the form is complete, just print, and send with any required attachments to the following address:

BioMed IRB
P.O. Box 600870
San Diego, CA 92160

If you do not use MS Word, or you have any questions regarding how to use or print the forms, or questions regarding IRB submission, please call: (619) 282-9997 or e-mail: mailbox@biomedirb.org for assistance.