Access Keys:
Skip to content (Access Key - 0)

Center For Cancer Research National Cancer Institute
Clinical Research Operations

Protocol Templates and Forms

1) Protocol Submission and Review

Major changes have occurred in the following 3 sections: 

Section 2.3:  Updates the web address for the CRO and updates participating site registration for multi-center protocols. 

Section 7:  Updates the definitions and reporting requirements for unanticipated problems, protocol deviations, and non-compliance per the recently issued NIH SOP 16.  Also includes updates to the requirements for reporting events to the IRB at continuing review. 

Section 8:  Updates the guidelines for statistical considerations.

Precis:
2) Protocol Deviations and Unanticipated Problems

 Definitions:

Protocol Deviation (PD):  Any change, divergence, or departure from the IRB-approved research protocol.

Unanticipated Problem (UP): Any incident, experience, or outcome that meets all of the following criteria:

  • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  • Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Deviations and Unanticipated Problems are reported to the NCI IRB via iRIS.

3) Informed Consent/Assent
Non-English Speaking Research Subjects:
  • NCI Short Form Addendums version 1 - using optional studies language that was approved prior to April 2012.  Please be sure that the Addendum that you select matches your protocol. 
  • NCI Short Form Addendums version 2 - using optional studies language that was approved after to April 2012.  Please be sure that the Addendum that you select matches your protocol. 
4)  Exemption from IRB Review
Human Biospecimens:
5) Report Templates