Protocol Templates and Forms

1) Protocol Submission and Review
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:

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

3) Informed Consent/Assent
Non-English Speaking Research Subjects:
4)  Exemption from IRB Review
5) Report Templates