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)