Clinical Research Center

Instructions on how to submit a protocol to the Massachusetts General Hospital Clinical Research Center (CRC)

PLEASE NOTE:  Protocols maybe submitted to the HCCRC for review before IRB approval has been granted.  However, IRB approval is required before a protocol maybe officially approved on the CRC. 

Protocol reviews may take approximately 1 month to review in the Clinical Research Center so please plan accordingly when submitting your protocol applications for review.

 

Link to Protocol Submission Page:   (you will need a eCommons  user name and password to log on)

 

How to Obtain an eCommons User Name & Password:

Go to the following website: (eCcommons Harvard Medical Intranet) please click "New User Registration" at the bottom of the screen. As a member of a Harvard-affiliated hospital, you are able to get an HMS eCommons login by providing your date of birth of social security number. Click "Register Now." Complete Step 1 and Step 3. (You can skip Step 2). A record will not be found for you in the system, which is fine since you don't have a login name. Click "Continue" and complete the fields in the Provide Information Screen. This will submit a request for a login name. You username and password will be emailed to you. Contact information for the HMS help desk appears on the screens as you're filling out the information.

 

Other Information Required (this information may be emailed back to Faith Fortune (ffortune@partners.org):

1)  Doctors Orders (needed in order to complete initial review of study)  Note: Please do not use older versions of the doctors orders templates or from previous studies).   Link to Doctors Orders Instruction Page        

2)  The CRC New User form is required for all staff using the CRC.  This information is needed for gaining access to CRC programs as well as adding your contact information to our database.   Link to CRC New User Form (doc)

3)  Biographical Sketch and Other Support Information:  Link to Biographical Sketch and Other Support Page       

4)  Need copy of study budget (Please send to Edwin Andrews at ebandrews@partners.org) or contact him directly at 617-726-6885 for more information.

 

Steps in The CRC Review Process

1.   The protocol is submitted for review through the online review program.

2.   The Resource Review of the study starts (approx. 5 days to review the protocol)

3.   If applicable, Scientific Reviewers are assigned to review the study and have (approx. 10 working days to review)

4.   Once all the comments have been entered, they are then combined onto a critique sheet/file and sent to the 
      Principal Investigator for clarification.

5.   The Principal Investigator then addresses the questions in red under each question/entry.  Once this form     is completed, then the PI will send the critique sheet/file back to the Lead Admin (Faith Fortune) on the study.

6.   The file is then sent to the original reviewers for final review and approval. (approx. 7 working days to review)

7.   Once IRB Approval has been granted and the doctor’s orders and scheduling template(s) have been approved,
      final CRC approval will be granted for the study and the Approval letter will be emailed out to the PI and Study
      Contact. 

No subjects maybe seen on or off of the CRC using CRC resources without the CRC Approval Letter being granted.

 

FREQUENTLY ASKED QUESTIONS:

  1. Question:  What is a SPID#? 
    Answer:   A SPID number is the "Subproject Identification Number" for a CRC study which is assgined when the study is submitted to the CRC for review.  Example:  SPID 0001
  2. Question:  When will a Protocol Nurse and Nutritionist be assigned to the study?
    Answer:  A Protocol Nurse and Nutritionist will be assigned to the study once the study has been submitted for review.