The General Clinical Research Center (GCRC) supports many projects from various and diverse disciplines within the Northwestern research community. Last year, the GCRC provided support for fifty-seven active protocols from fourteen Feinberg School of Medicine departments or divisions.
Eligible investigators supported by the National Institutes of Health (NIH), other federal agencies, state and local entities, or the private sector may use the GCRC. The center is required to give first priority to NIH-funded research projects should there be a need to selectively allocate resources during periods of high demand and utilization.
The principal investigator, or a named co-investigator, must have admitting privileges at Northwestern Memorial Hospital. All research activity conducted at the GCRC must be part of a Scientific Advisory Committee (SAC) reviewed and approved protocol. If an investigator wishes to apply to use GCRC resources, a GCRC application may be obtained from this Web site, or from the GCRC administrative office. The GCRC administrative director and center assistant will be glad to provide information and assistance to the investigator and research coordinator with the application and the SAC review process. Utilizing GCRC resources means that the approved project is supported in some way by the GCRC grant. The GCRC application process thus follows National Institutes of Health (NIH) and National Center for Research Resources/GCRC guidelines and requirements for: - format of scientific sections and references
- human subjects protection information
- research support listing for all primary investigators
- inclusion of women and minorities
- inclusion of children
- Data Safety and Monitoring Plan (DSMP)
- training in human subjects protection
- GCRC utilization and budget information and categories
It is strongly recommended that the principal investigator or coordinator contact the GCRC office before submitting the application to discuss and verify the requested GCRC resources. An important resource for the investigator is the GCRC Investigator Manual, which describes in detail GCRC resources and facilities, and the application and study initiation process. The completed application should be submitted to the GCRC office. Where the application will be reviewed for format and budget concerns. Budget issues should be discussed with the administrative director. Investigators should note that limited direct ancillary support may also be requested for Northwestern Memorial Hospital and off-site ancillaries for investigator-initiated protocols. The SAC meets monthly to review GCRC applications. The meetings usually occur on the second Thursday of the month. See the SAC Meeting Schedule for more information about dates, times, and locations of the meetings. The SAC review addresses: - scientific concerns, including a biostatistical review
- suitability of GCRC utilization
- Data Safety and Monitoring Plan (DSMP)
- human subjects protection information and consent
The principal investigator or a primary co-investigator is required to attend the SAC meeting, make a brief presentation of the protocol, and address questions and areas of discussion with the SAC committee. Following the meeting, the administrative office will inform the investigator of the committee's decision by both e-mail and written letter. All research team members of GCRC-supported projects must complete the NIH Web-based training module and provide a copy of the certificate of completion to the GCRC administrative office. The NIH module, "Human Participant Protections Education for Research Teams" is described at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp After a protocol has received full Institutional Review Board (IRB) and Scientific Advisory Committee (SAC) approval, the study may be initiated at the GCRC.
Before visits or admissions are scheduled, the principal investigator and the research team are required to present an inservice to GCRC staff, so that all GCRC research personnel may be fully informed and prepared for the needs of the study and its patients or participants. Standing orders and flow sheets should be prepared by the research team before the inservice. When patients are scheduled, GCRC procedures for pre-registration and scheduling must be followed for all inpatient and outpatient admissions. - Scheduling Subjects at NMH
- Writing Orders for GCRC Protocols at NMH
The research team is expected to communicate all new IRB approval letters and newly stamped consent forms to the administrative office and nursing personnel. In addition, send a copy of all IRB submissions (AE reports, revisions, etc.) as well as IRB communication (i.e., PI response to pending letters) to the Research Subject Advocate (RSA).
After a study becomes active, the GCRC administrative office may occasionally request information from the principal investigator or research team. These requests will be made only when necessary, for the following reasons:
- GCRC annual report to the National Center for Research Resources
- GCRC center grant applications
- billing concerns or corrections
- quality assurance
- surveys of general investigator needs or comments
The GCRC also requires copies of all IRB submissions and status updates.
The GCRC staff is dedicated to supporting the successful conduct and completion of research protocols. We request that investigators support the center by acknowledging the GCRC grant in publications resulting from their GCRC protocols. Your acknowledgement of the GCRC is essential to our success.
When citing the GCRC grant in publications, please use the following credit information:
Supported in part by grant M01 RR00048 from the National Center for Research Resources, National Institutes of Health | 
