PLEASE NOTE: Protocols maybe submitted to the Harvard Catalyst Clinical Research Center (HCCRC) for review before IRB approval has been granted. However, IRB approval is required before a protocol maybe officially approved on the Translational and Clinical Research Center (TCRC).
Protocol reviews may take approximately one month to review in the Translational and Clinical Research Center, so please plan accordingly when submitting your protocol applications for review.
Note: Please make sure when you are uploading the documents into the Protocol Review Program that the documents being uploaded are not password protected.
LINK TO RESOURCE REVIEW SUBMISSION PAGE: (you will need a eCommons user name and password to log on) Please open the program using Google Chrome or Firefox
Protocol Review Program scheduled maintenance downtime, occurs every month on the third Saturday of the month from 6:30 pm until 12:30 pm Eastern Time. The program will not be accessible during this time. Please make sure you have logged out of the program during this time. Thank you.
Please read: Communication with Study Teams re: Epic
How to Obtain an eCommons User Name & Password
- Go to the following website: eCommons 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.
- Your 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 with Protocol Submission
This information may be emailed back to Faith Fortune (firstname.lastname@example.org):
- The TCRC New User form is required for all staff using the TCRC. This information is needed for gaining access to TCRC programs as well as adding your contact information to our database. Download CRC New User Form (doc)
- Biographical Sketch and Other Support Information:
Steps in the TCRC Review Process
- The protocol is submitted for review through the online review program.
- The Resource Review of the study starts (approx. 5 days to review the protocol).
- If applicable, Scientific Reviewers are assigned to review the study and have (approx. 10 working days to review).
- Once all the comments have been entered, they are then combined onto a critique sheet/file and sent to the Principal Investigator for clarification.
- 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.
- The file is then sent to the original reviewers for final review and approval (approx. 7 working days to review).
- 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 may be seen on or off of the TCRC using TCRC resources without the TCRC Approval Letter being granted.
Frequently Asked Questions
Question: What is a SPID#?
Answer: A SPID number is the "Subproject Identification Number" for a TCRC study, which is assigned when the study is submitted to the TCRC for review. Example: SPID 0001
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.