The Modification form is what to use when trying to make a change to your study. Filling the questions out completely is crucial for the reviewer looking at it to fully understand WHAT you are changing and WHY. Here are some tips on two of those questions that are often neglected:
“Please describe the requested change”: Please use this question to summarize the changes. We need to know more than “revised protocol and consent form.” Have the inclusion criteria changed? How? Has the compensation increased? Are you now using a ClinCard instead of sending people checks? Have you added more detailed information to your recruitment ad? Are you changing the recruitment strategy?
“Notes for the IRB reviewer(s)”: This is often answered “n/a” or is a cut and paste copy of the answer above. Instead, use this response to say WHY you are making the changes you are making- for example, the inclusion criteria have been broadened because we realized we needed an additional diagnosis group; we are hoping that an increase in compensation will improve attendance at the final study visit; the ClinCard is much easer to manage than sending checks was; we need to screen out participants who smoke so we are changing the recruitment ad to mention that.
Filling these two questions out completely will speed your review, as the reviewer can more quickly isolate the changes and will not have to guess at the reason prompting the change.