Protocol Templates and Forms
1) Protocol Submission and Review
- NCI-CCR Protocol Template and Guidelines (Word, 7/18/12)
Major changes have occurred in the following 3 sections:
- Section 5, biospecimens collection: This raises many questions that should be addressed if the protocol involves genetic/genomic analysis. If these issues are addressed upfront, this can reduce stipulations at the time of IRB review.
- Section 7: Has updated language for safety reporting that is required by OHRP, FDA, OBA and IBC, in addition to current language regarding safety monitoring plans.
- Section 9, collaborative agreements: This is a new section which has been added so that all collaborations with outside investigators can be clearly identified in one section of the protocol.
Precis:
- Precis Format (Word)
- Precis Example 1 (Word)
- Precis Example 2 (Word)
2) Protocol Deviation and Violations
Definitions:
Protocol Deviation: Any change, divergence, or departure from the IRB approved study procedures in a research protocol that does not have a major impact on the subject's rights, safety or well-being, or the completeness, accuracy and reliability of the study data.
Protocol Violation: Any change, divergence, or departure from the IRB approved study procedures in a research protocol that does have a major impact on the subject's rights, safety or well-being, or the completeness, accuracy and reliability of the study data.
Deviations and Violations are reported to the NCI IRB via iRIS.
3) Informed Consent/Assent
- NCI Consent Form Template (Word, Posted January 18, 2013)
- Model Consent Language - Genomic Sequencing (Word, v. 12.8.10, Posted March 22, 2011)
- 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.
