For a discussion for your project call:

The application on this website is meant to be completed on your own computer. Emailed applications will not be accepted. Please note: two collated copies of the application should be delivered to Courtney Alpert, Fuller Building 9th Floor, Suite 900.

Courtney Alpert
Solomon Carter Fuller Building, 9th floor
85 East Newton Street
(617) 638-4544

Application Submission Dates:

• June 25, 2008
• August 27, 2008
• October 29, 2008
• December 18, 2008
• February 25, 2009
• April 29, 2009
• June 24, 2009
• August 26, 2009
• October 21, 2009

Application Submission Instructions:

The application on this website may be downloaded as a Word document.

It is recommended that GCRC applications are submitted at the same time as IRB applications. IRB approval IS NOT required prior to submission to the GCRC.  In order to be accepted for review, however, the IRB application status must be marked "SUBMITTED" at the top left-hand corner of the application front page.  IRB applications with any other designation (draft, awaiting signature, etc.) will not be accepted for review.  In order for a GCRC application to be considered complete, it must include the following:

1. GCRC Application (Signed original and 2 copies). For assistance with the GCRC application, please call Courtney Alpert at 617-638-4544 or email Courtney Alpert.

2. Data Safety and Monitoring Plan (DSMP - 2 copies). Please note that the DSMP must be signed by the study PI prior to submission with the GCRC application.  (This signed version must also be attached to section S of the INSPIR IRB application).
   For assistance with the DSMP, please contact Mary-Tara Roth RN, MSN, MPH at 617-638-8876 or email Mary-Tara Roth.

3. IRB Application and Materials (2 copies of all):

   1. Application and detailed protocol

   2. Consent/Assent Forms

   3. HIPAA authorization forms (if not included in Consent Form)

   4. IRB letter of approval (if pending IRB review, please note)

4. Industry Protocol (if applicable – 2 copies)

   1. Sponsor Protocol

   2. Investigator Drug Brochure

5. NIH Educational Program certificates for all listed personnel (2 copies)

6. Conflict of Interest Disclosure Form for P.I. only (2 copies)

7. Checklist signed by the P.I.  (1 copy)

Janice Kopp
Administrative Director

ph: (617) 638-4542
fax: (617) 638-8890
jkopp@bu.edu

Courtney Alpert

Administrative Coordinator

ph: (617) 638-4544

fax: (617) 638-8890

alpertc@bu.edu

WEBSITE:

NIH Certification

INSPIR

FORMS:

Checklist

GCRC Application

DSMP Plan

Conflict of Interest