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Protocol Development Activities (PDA) Guidance
Version Date: June 14, 2011
Guidance for completing application for protocol development activities only
The Protocol Development Activities Only submission form is to facilitate the submission of grant application to the IRB for review when 1) research activities involving human subjects are planned for the future but have not been finalized (e.g. the grant incorporates a planning stage); 2) when an agency or organization requires IRB approval of the concept as part of the application for funding; and 3) when a research team has received a "just-in-time" requesting documentation of IRB approval. In order to obtain approval to perform research activities involving human subjects, a separate Initial Review Application or Application for Exemption from IRB review will be required. Only planning activities that do not involve human subjects can be covered by this administrative approval. In some cases, an Application for Exemption may be a more appropriate form to submit.