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.
2) Protocol Deviations and Unanticipated Problems
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.
- CCR Problem Report Form (Word)
3) Informed Consent/Assent
- Assent Template (Word)
Non-English Speaking Research Subjects:
- Short Written Consent Forms for Non-English Speaking Research Subjects (NIH Access Only)
- 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 April 2012 and prior to May 2015. Please be sure that the Addendum that you select matches your protocol.
- NCI Short Form Addendums version 3 - using optional studies language that was approved after April 2015 and prior to November 2015. Please be sure that the Addendum that you select matches your protocol.
- NCI Short Form Addendums version 4 - using optional studies language that was approved after October 2015. Please be sure that the Addendum that you select matches your protocol.
- NCI Addendum to Short Form - blank form for translating portions of the consents with yes/no questions for those consents where the questions can not be removed.