Upload initial documents for IRB review into each appropriate section of the new study application. This will become the document's 'tracked' stack. Track all modifications to documents after the PI submits the application, even within a new application.
For amendments modifying study materials, upload a tracked version of the document to eResearch. Ensure any subtitle & version # in the document (e.g. footer) are updated.
Maintain one 'tracked stack' of documents in eResearch for each (for studies with multiple consent documents). Each updated/tracked version for a given document should be stacked via the 'Upload Revision' function into its existing 'tracked' stack. Only 'Add' new document stacks for entirely new documents.
Note: Documents uploaded into section 44 may not require both tracked & clean stacks. Please work with IRBMED Staff when making revisions to these documents.
Follow the standard naming convention outlined below in Section IV. Updating the stack title is not required, and actual document title (i.e. filename) need not match stack title.
Do not delete any documents or stacks of documents from eResearch; these are retained for historical reference purposes.
Do not alter or remove the consent/assent cover page in the IRB-maintained “Clean” stack(s) in 10-1.1. This page is "silent", meaning it will disappear during eR document finalization.
Do not use documents stored outside of eResearch as these may be previous versions instead of the latest IRB approved version. IRBMED Regulatory Staff verify the correct document was used via the document’s cover page and the Microsoft Word ‘Compare’ function as an initial step in their review.