The MGH Clinical Research Center
a member of the Harvard Catalyst CTSC
CRC PROTOCOL SUBMISSION INSTRUCTIONS
Document Requirements for CRC Submission
PART 1
-
Turbo Application
1. Investigator or study staff must contact Faith Fortune, Administrative Coordinator (ffortune@partners.org), to
obtain access to the Turbo Protocol Application Program. The Turbo protocol is the CRC Advisory
Committee (GAC) approved application form.
PART 2
-
NIH Summary Sheet
1. The NIH Summary Sheet will need to be submitted with your application for (NIH funded only studies).
This will be needed as an alternative to the CRC Scientific Review of your study. Please email this
document as a PDF file to ffortune@partners.org
PART 3
-
HRC Application Forms
Protocol Submission Packets - 9 hard copies of all materials noted below should be collated into 9 packets for
the CRC Advisory Committee Reviewers. Please deliver these packets to the attention of Faith Fortune, CRC,
White 1301. NOTE: For Core-Only studies (if you are only using one CRC resource (Bionutrition Only, Core
Lab Only, Biostatistics Only), 4 copies of these items are to be submitted.
1.
Complete MGH HRC application, as submitted to the HRC. This includes the following:
 HRC Application Forms
 HRC Approval Letter. If you have already received IRB Approval when submitting your new
application to the CRC, please include your IRB Review Questions/Comments with your packets.
 Most recent Protocol Summary
 Most recent Detailed Protocol
 Most recent HRC Stamped Consent Form(s) (this may be draft if not IRB approved)
 If study is funded by a Sponsor, please include Investigator’s Brochure
 Any prior amendments, with accompanying documentation (if applicable)
PART 4
-
Forms to be Emailed
The below information should be emailed to the attention of Faith Fortune (ffortune@partners.org):
1.
The completed Turbo file
2.
Electronic Copy (by Email to ffortune@partners.org) of the most recent Doctor’s orders, even if they are
in draft format. (to obtain a copy of the doctors orders template please contact Faith Fortune)
3.
Biosketches for PIs and Co-Investigator’s with complete Other Support page included, or as a separate
document.
4.
A completed CRC new user form for all study staff must be sent to Faith Fortune. You may find this on
the CRC web site, http://www.mgh.harvard.edu/CRC.
Rev: 01/28/09
PART 5
1)
-
Budget
Budget for your study, as required by the NCRR guidelines.
Administrative Manager or via email at ebandrews@partners.org
PART 6
-
Forward one copy to Ed Andrews,
Publications
Each publication, press release or other document that cites results from NIH grant-supported research must
include an acknowledgement of NIH grant support and disclaimer such as "The project described was supported
by Grant Number 1 UL1 RR025758-01, Harvard Clinical and Translational Science Center, from the National
Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily
represent the official views of the National Center for Research Resources or the National Institutes of Health".
If your study utilized CRC resources (prior to 5/31/08), please use Grant Number M01-RR-01066. Please use
both Grant Numbers if appropriate.
At the completion of the GAC review process, an approval letter will be e-mailed to the PI from Faith Fortune,
Administrative Coordinator, on behalf of the CRC Advisory Committee.
ORIENTATION TO THE CRC SLIDE PRESENTATIONS
Please have staff go to the CRC website at http://www2.massgeneral.org/crc/orientation.htm
and view the GCRC Orientation slides. Please let Faith Fortune know once they all have been read. Reviewing
these presentations will facilitate communication amongst CRC staff, investigators and study staff. We hope that
you will become familiar with the operations of the CRC upon your review of the orientation presentation.
OTHER INFORMATION NEEDED AFTER PROTOCOL SUBMISSION
1.
Amendments - Modification of a Research Protocol
All amendments submitted to the Human Research Committee MUST also be submitted to the CRC
Advisory Committee for review after HRC approval.



2.
HRC Amendment Approval Letter with accompanying Amendment Form
All documents that change with the amendment (i.e. Protocol Summary, Detailed Protocol, Consent
Forms, Investigators Brochure, DSMB Minutes etc…)
As part of the amendment review process, a new Turbo Revision File must be updated for protocol
changes. Please contact Faith Fortune to obtain the latest Turbo Revision file to edit. Please email
this file back to Faith Fortune once completed.
Doctors Orders
Changes to the doctor’s orders should be worked out with the Protocol Nurse and/or Bionutritionist as
needed. Once the new changes are incorporated please forward all the doctors orders in MS word
format to Faith Fortune (ffortune@partners.org) for posting and final approval.
3.
Termination of the Protocol
The Principal Investigator must notify the CRC Advisory Committee that the study has been terminated
when Data Analysis has been completed.
Please see bottom of this page for more documentation……
Rev: 01/28/09
The MGH Clinical Research Center (CRC)
a member of the Harvard Catalyst Clinical Translational Science Center (CTSC)
Phone: (617) 726-6886
Fax: (617) 724-3299
Please insure all the information is accurate and complete. Once you have completed the form, please fax it to the number
shown above. If you have any questions or comments, please direct them to (617) 726-6886.
USER INFORMATION
MGH Provider Number:__________
NIH eraCommons Name required for: (MD’s & PhD’s):_____________
Full Name: (Last, First MI):____________________________Date of Birth:_____(mm/dd/yy)
Degrees (abbreviated)____________________________________________

Institution:
MGH
 MIT  BWH
 Other__________________________
Department:_____________________________________________
Location Bldg:_____________
Phone #: __________
Fax #:
Floor: ____________
___________
Room#:___________
Beeper #:_______ Internet Address:________________________
Who are you replacing:_______________________________
Your Role:
 Principal Investigator  Co-Investigator
 GCRC Program Staff  Nurse Practitioner
 Nurse
 Study Coordinator
 Research Support Staff
Protocols you are affiliated with on CRC (Please list SPID#'s):_________________________
PHOTO I.D. RELEASE
To better help us identify you when you are on the CRC, are you willing to release your photo ID picture from Police & Security for us
to use to help identify you on the unit? If so, please check box and fill out the form attached. Please fax this form to Faith Fortune (617)
724-3299. 
WHAT ITEMS WILL YOU REQUIRE?



Access to posted CRC Doctors Orders for the Protocols Associated (Listed under MyNetwork Places on Desktop in
folder called GCRCM_DO
Will you be scheduling patients on the GCRC through the Turbo Scheduler Program. If so, do you need access?
MGH Log On Name:____________
example: MPB0 Required field
Access to Turbo Application Program. If you need Turbo Training, please contact Faith Fortune
(ffortune@partners.org) to schedule a time for training.
ORIENTATION TO THE GCRC SLIDE PRESENTATIONS
Please go to the CRC website at http://www2.massgeneral.org/crc/orientation.htm and view the CRC Orientation slides.
Please let Faith Fortune know once they all have been read. Reviewing these presentations will facilitate communication
amongst CRC staff, investigators and study staff. We hope that you will become familiar with the operations of the CRC
upon your review of the orientation presentation.
 Please check box once slides have been viewed and read.
Rev: 01/28/09
MASSACHUSETTS GENERAL HOSPITAL
II.
POLICE AND SECURITY DEPARTMENT
PHOTO IDENTIFICATION ACKNOWLEDGEMENT
AND CONSENT FORM
I hereby acknowledge the following:
1. I have received a photo identification/access card issued by the Massachusetts General Hospital
Department of Police & Security in accordance with MGH/PHS Personnel policies and procedures.
2. I hereby grant consent for my photograph to be used in Massachusetts General Hospital/Partners Health
Care System publications or other applicable MGH/PHS business. I relinquish any right, title or interest
in such photograph(s) and to any control over their use, and to any proceeds that may arise therefrom. I
agree to hold Partners Healthcare Systems and its affiliates harmless from any and all liability arising from
this photograph and any news articles printed or broadcast as a result of this photograph.
3. In furtherance of the permissions granted herein I hereby grant permission for the Massachusetts General
Hospital Police and Security Department to provide an electronic or other type media copy of the image
maintained for the purposes of issuing my Photo Identification Badge to other Massachusetts General
Hospital/Partners Health Care System departments, affiliates or entities for use in publications
Last Name
First Name
Department Name
Work Location
Signature
Date
Rev: 01/28/09
MI
Credentials
Phone Number
PeopleSoft Number (MGH ID Number)