Post-approval Submissions

Amendment

Any changes to approved research protocols should be submitted for review. This may include any of the following:

• Addition or removal of study personnel
• Addition of new study location
• Addition of new study procedures
• Identification of new risks to subjects
• Changes to study interventions
• Development of new recruitment materials
• Revisions to informed consent process or documentation

To submit an amendment, navigate to the Investigator dashboard in eProtocol. Select the Protocol ID for the study which you wish to amend under the "Active Protocols" section. An option will be available to "Create Amendment," and click it to open the approved protocol in a new window.

Be sure to describe all changes to the protocol fully in the Amendment section of the protocol, and then navigate to the respective sections of the protocol that will include those revisions. Make any and all edits throughout the protocol, and include any new or replace any revised documents in either the Informed Consent or Attachments sections. When the amendment is submitted, all changes will be identified for the reviewer, so there is no need to designate changes in the protocol itself.

Renewal

Only protocols which have been reviewed by the Full Board, are identified specifically by the Full Board, or are funded by the Dept. of Defense, require annual renewal. Exempt research does not require any annual renewal, and most Expedited studies do not require annual renewal.

If your research requires renewal, Select the Protocol ID for the study which you wish to amend under the "Active Protocols" section. An option will be available to "Create Continuing Review," and click it to open the approved protocol in a new window.