• The NIH requires the following acknowledgement when publishing any article, abstract or chapter, even partially based on a GCRC Protocol:

“Supported in whole or part by the North Shore – LIJ Feinstein Institute for Medical Research, General Clinical Research Center Grant # M01 RR018535”

• All SAEs associated with GCRC protocols will be reported within 24 hours of the occurrence (or within 7 calendar days of receipt of the report on a multi-center trial) to the GCRC Research Subject Advocate
  
  
• Submit protocol and informed consent form modifications to the GCRC Advisory Committee (GAC) for approval
  • Major modification requests must be submitted to and approved by the IRB prior to submission to the GAC.
  • Minor modification requests may be submitted to the IRB and GAC concurrently.
• In order to keep the GCRC up-to-date, please submit annual "continuing review" appraisal letters from the IRB.
  

• The Principal Investigator is responsible for obtaining informed consent and assent of research subjects, and providing the GCRC with a copy of the consent form, signed by the research subject, for the medical record per JCAHO regulations if subject is seen in a GCRC unit.
  
  
• The Principal Investigator will submit to the Research Subject Advocate a written plan for data monitoring and safety of the subjects (DSMP) with the protocol and will submit monitoring reports as per this plan.
  
  
• The Principal Investigator will submit, by fax, any demographic and visit forms that are completed remotely (not at the GCRC unit)
  
  
• In-Service Meetings are required once GCRC approval is granted and prior to the initiation of any study procedures.  Please contact the Nurse Manager (516-562-1012) to book this appointment.  This will aid in the designing of physician orders and flow sheets.