Read-Only Questionnaire
The Questionnaire page of the Protocol document will display up to three types of Questionnaires: those that are required for a submission, those that were selected for amending, and those that are read-only and not required.
For new studies, only Questionnaires that are required to be completed for the initial submission will populate on the Questionnaire tab. When they have all been completed, the folder headings will change from red text to green and will read “Complete.”
Figure 648a Protocol Document – Questionnaire Page Layout
For amendments and renewals, the Questionnaire tab will populate with Submission Questionnaires required for the type of submission being created.
Figure 283a Protocol Document – Amendment Submission Questionnaire Page Layout
Figure 283b Protocol Document – Renewal Submission Questionnaire Page Layout
For amendment/renewal submissions on studies approved initially using a Protocol document that included Questionnaires (i.e., post-KC IRB Phase IV), any additional Questionnaire checked on the Protocol Actions tab in the Amend section as being updated will be listed under Amendable Questionnaires. Any Questionnaires not being updated will be listed under Read-Only Questionnaires; no changes can be made to these unless they are also selected on the Protocol Actions tab.
Figure 283c Protocol Document – Amendment Submission Questionnaire Page Layout
For amendment/renewal submissions on studies approved prior to implementation of Questionnaires (i.e., using Summary Safeguard Statement, Recruitment Checklist, etc.), all Questionnaires will be shown under Read-Only Questionnaires. They are incomplete for studies previous to Phase IV, and they will not prohibit amendment/renewal submissions from being completed and approved by the IRB. No action on the part of study teams is required for Read-Only Questionnaires.
Figure 283d Protocol Document – Read Only Questionnaire Page Layout