Completing the Protocol Development Activities Applications (PDAs)

This document provides guidance on how to complete key sections of a PDA in ARROW.

What is the purpose of the PDA Application Type?
The PDA was developed 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.

How to Complete the Study Team Roles Section
Because the PDA is limited to covering activities that do not constitute engagement in human subjects research, this limitation should be reflected in the Study Team Roles section of the IRB application. For questions 4.1, 4.2, and 4.3 shown below, choose “Not applicable”.  However, for 4.4 please identify a primary point of contact, which is required for all types of IRB applications.



How to Complete the Scientific Review: Other Section
Because the PDA is limited to covering activities that do not constitute engagement in human subjects research, scientific review is not required. In the case of studies not forwarded to the Cancer Center’s Protocol Monitoring and Review Committee and thus might qualify for other scientific review, please answer “No” to question 18.1 an select “Protocol Development Activities (PDA) application” as the reason why no scientific review is required as illustrated below.



How to Complete Clinicaltrials.gov Registration Section
Because the PDA is limited to covering activities that do not constitute engagement in human subjects research, registration with clinicaltrials.gov is not required even if the human subjects activities that will be reviewed by the IRB in a future application will require registration. Please select “No” for 20.1 on this page as illustrated below.



How to Complete the Type of Application Section
The Application Type section displays for every new IRB application. The Application Type section is the second section of the initial review application smartform. Study teams complete the first page of the Application Type section by selecting the 1 application type that is appropriate for their study or project. Choose the Protocol Development Activities (PDA) as the Type of Application in this section of the ARROW application, as illustrated below.



How to Complete the Protocol Development Activities (PDA)…Section
The PDA section asks for a description of the overall objectives of a) the grant/funding application, b) the preliminary activities that would be performed under the application; and c) the activities that will involve human subjects for which IRB approval will be sought in future.


 
Information for 11.1 can generally be pulled from the grant application or funding proposal.

For 11.2, the information provided here depends on the reason for the submission of the PDA. If the PDA is solely to provide evidence of approval in concept for a funding agency, please indicate this in 11.2 and note that no activities are planned. If the PDA is being submitted to release funds for preliminary activities that occur before those that would involve human subjects, describe the specific activities here. The activities should be described in sufficient detail to allow a lay reviewer to determine that activities involving human subjects will not be performed. Please note that if the activities involving human subjects likely qualify for exemption, an application for exemption may be the more appropriate Application Type to submit.

Information for 11.3 can generally be pulled from the grant application or funding proposal.





Keywords:protocol development activity   Doc ID:31524
Owner:Faye L.Group:Health Sciences IRBs
Created:2013-07-10 09:09 CSTUpdated:2017-07-05 14:48 CST
Sites:Health Sciences IRBs
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