Click on a form name in the table below to open the individual form. Save the form to your computer desktop and reopen it before completing.
|Supplemental Submission Forms||Instructions|
|Financial Interest Disclosure Form||Principal Investigators are responsible for ensuring that this form is completed for each member of the research staff reporting a financial interest related to the research as per the Study Personnel Information Form.|
|Drug, Biologics and Devices||This form is no longer in use. Instead, log onto ESTR: irb.harvard.edu and indicate when prompted that you will be using drugs, biologics, and devices. Upload any required documents in the “Supporting Documents” section when applicable.|
|Modifications Required to Secure Approval||This form is no longer in use. Log into ESTR: irb.harvard.edu and respond appropriately.|
|Reportable New Information||This form is no longer in use. Instead, log into ESTR: irb.harvard.edu and choose the “Report New Information” button on the study dashboard and follow prompts. Report new information within 5 business days from the time the study team became aware of the information.|
|Study Personnel Information||Upload this form to the “Supporting Documents” section within ESTR: irb.harvard.edu when study staff do not have a Harvard ID (e.g., external collaborators). Otherwise, all other applicable staff should be listed in ESTR: http://irb.harvard.edu where prompted.|
|Translation Attestation||Upload this form in ESTR: http://irb.harvard.edu under “Supporting Documents” at the time of an initial application if any study documents will be administered in languages other than English. You must also submit this form if, as part of a study modification, you are requesting to add new study documents that will be translated. Copies of the locally-approved translated versions should be submitted to HSPH when they become available, however resubmission at subsequent continuing reviews is not required.|
Questions about what to submit? Please contact us.