Any changes that must be made to an active, approved protocol should be submitted as a modification. There are two types of modifications, minor or major.
Minor modifications do not significantly alter the study design or increase the risk to participants. An example of a minor modification includes adding research personnel to the protocol.
Major modifications involve any increase in risk to participants is more than minimal, OR any additional activity or procedure would not be eligible for expedited review if submitted as part of new research, OR the research itself involves more than minimal risk and the changes significantly alter the study design. An example of a major modification includes adding or removing major procedures.
In order to submit a modification, log in to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Then click My Protocols, and select the protocol you would like to modify. Once that page loads, scroll down and click the Modification tab. Click Create New Modification.
Select minor or major modification type. Upload the required modification memo (please download our Modification Memo Form Template for an example) and explain the changes and supplementary documentation related to the modification memo. Please itemized each change one-by-one using the memo template format.
Then, include a tracked changes version of all documents that you want to revise (e.g. consents, recruitment material, application, etc.). Use the tracked changes function to clearly show where you made the changes within each document.
Include a final clean version of all the files with accepted tracked changes as part of your modification submission.
To replace an item you would like to modify in TC Mentor IRB, click on the page icon (with the maroon lines) next to the document in question and select "replace." Do NOT delete the old document. Please email your reviewer when you have submitted a modification as the IRB office will not receive an automatic notification.
Please review our How to Submit a Modification, Continuing Review, Adverse Event, and Deviation PDF for more detailed instructions and information on this topic. For more information on preparing IRB related documents, please visit our Writing for an IRB Review page. Additionally, TC IRB has written several blogs providing more information about the modification process.