Protocol Preparation

Prior to the submission of a protocol to the IRB or the GAC, any of the GCRC resources outlined earlier are available for consultation with an investigator or staff.
Consider the following questions when developing your protocol:

• Has the research team toured the
  PCRC and is it familiar with the resources available?
• Is the proposed protocol appropriate for the PCRC use?
• Are PCRC billing procedures understood by the research team?
• Is there a need to consult with the PCRC biostatistician on study design or data analysis?
• Is there a need to consult with research bionutritionist?
• Are there patient care or clinical issues that should be discussed with the nursing staff, (e.g. special needs of the patients to be enrolled)?
• Do you have an IRB approved informed consent form?
• Do you have a Patient Safety Monitoring Plan in your protocol?
• Notice of required education: As of October 1, 2000, all key personnel involved in human research protocols must receive relevant training. "Key personnel" in this context is defined as those involved in the design and/or conduct of the study. For information regarding the current training requirements, please contact CNMC IRB office at Tel. 202 884-5277.