Study teams will upload the initial informed consent document for IRB review into Section 10-1 of the new study application. For subsequent amendments which modify informed consent documents, study teams will only upload a track changes version to eResearch. Study teams should not upload “clean” versions as IRBMED will label and upload the clean version to Section 10-1.
Study teams should maintain one “stack” of documents in eResearch for each separate consent document (for studies with multiple consent documents). Each new version for a given document should be stacked on the previously uploaded final draft. Each subsequent track changes version should be stacked on the previously uploaded track changes version.
Informed consent documents uploaded in eResearch need to follow the standard naming convention outlined below in Section IV.
Do NOT delete any documents or stacks of documents from eResearch; these are retained for historical reference purposes.