The administration department of the Massachusetts General Hospital Clinical Research Center (CRC) manages the grant funds, calculates ancillary support for investigator-initiated studies, facilitates administrative interactions between CRC staff members and study teams and maintains CRC computer systems and the CRC website. Administration helps investigators understand the resources available and how to access them on the CRC.
Primary functions of MGH CRC Administration include:
- Processing new applications
- Coordinating protocol review with all disciplines, including scientific review
- Reviewing and approving ancillary requests for individual protocols
- Managing financial and other administrative reporting to sponsor
- Managing grant financial activity for the CRC
- Billing study teams for above standard activity
- Maintaining CRC computer systems, including those related to scheduling of research subjects
- Maintaining the CRC website
How much will the CRC support in ancillaries for my study?
The CRC grant provides up to $60 average per outpatient visit or inpatient day for Junior Investigators (Assistant Professor or below) and up to $30 average for Senior Investigators (Associate Professor or above) for most investigator-initiated studies. This amount is calculated on a per-visit average and is subject to change, based on budgetary limitations.
Will the CRC pay for offsite (any visit not conducted on White 13 or CNY) visits?
Yes, the CRC will provide financial support, including ancillaries, for offsite visits, similar to onsite visits.
What if our research subject receives a bill for a study visit?
Please fax [617-724-3299] or deliver the bill or invoice to CRC administration on White 1301 and we will investigate. If it is appropriate for the CRC to pay for services on this invoice, we will provide the fund number to the billing agency. If it is not a service covered by our grant, we will notify you.
Will the CRC pay for professional fees?
CRC regulations prohibit our funds from being used for payment of professional fees.
What visit Information do you need to provide?
You may be asked to provide visit information on an ancillary only visit or other offsite visit. If your study has offsite visits, please contact Faith Fortune for the form to be completed on a monthly basis for your study.
Each publication, press release or other document that cites results from NIH grant-supported research much include an acknowledgement of NIH grant support and a disclaimer. Please refer to How to Reference a Publication to the CRC.
How long is the study approval process?
Studies are generally approved on the CRC within 30 days of submission. Approval of a study could be affected by a delay in HRC approval and/or delays in responses from the CRC reviewers and/or investigator.
What is the process for approval of a protocol?
See Information for Investigators on our website. In summary, the CRC protocol team, including scientific reviewers, reviews the protocol and provides comments on a critique sheet. The critique sheet is edited and forwarded to the Principal Investigator for a response. Approval is contingent on a satisfactory response to the critique, finalizing study orders and completing scheduling templates. Once this process is complete, a CRC Approval Letter is sent to the PI from Faith Fortune. Scheduling may then commence.
What is the protocol review process for “core-only” protocols?
Core-only protocols (i.e. that is studies only requesting laboratory support or, Metabolism & Nutrition support only, etc.) undergo a review that is limited to the Core group, Administration, and scientific reviewers, as appropriate.
If you have any specific questions, please contact the following:
Edwin B. Andrews, Administrative Director
Ellen J. Anderson, Metabolism & Nutrition Research Director
Kathryn E. Hall, Nursing Director