One of the main reasons submissions are sent back to the researcher is missing documentation.
Our ESTR SmartForm pages clearly outline which documents should be uploaded into which SmartForm section. ESTR decides which document receives an “IRB Approved” stamp based on where it is uploaded. This is especially important with informed consent forms.
If a document is uploaded to the wrong section of the SmartForm, your IRB Reviewer will send the submission back for clarifications to request that the document be placed in the correct section.
Here is a guide to help you upload your documents in the correct SmartForm section in ESTR:
Sort |
CUHS Protocol Template |
Not Human Subjects Research Form |
|
| |
HUID Holders | HRP-220 for non-Harvard University Area study team members |
| CITI certificates for non-Harvard University Area study team members |
Consent Forms & Recruitment Materials |
Consent Forms |
Assent Forms |
Recruitment Materials |
|
Study Instruments |
Interview Guides |
Surveys |
Any other applicable documents |
Tip: Several pages in ESTR have a list of Suggested Attachments. Take a quick look at these lists as you are completing the SmartForm to see if there is anything else you should upload