Protocol Templates and Forms
1) Protocol Submission and Review
- NCI-CCR Protocol Template and Guidelines (Word, 08/27/2013)
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.
- NIH Problem Report Form (Word)
3) Informed Consent/Assent
- NCI Consent Form Template (Word, Posted January 18, 2013)
- Model Consent Language - Genomic Sequencing (Word, v. 11-5-13, Posted November 12, 2013)
- Assent Template (Word, Posted November 9, 2009)
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 to April 2012. Please be sure that the Addendum that you select matches your protocol.
4) Exemption from IRB Review
- Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol (PDF)