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Keep it short and to the point when responding to modification contingencies

So you’ve submitted a modification, the IRB had a question on it that was returned to you as a contingency, and now you’re responding.

And then you remember you just received some new information from the sponsor that the IRB needs to see, or that you need to make a change to a study document that wasn’t included in the original modification. Should you just go ahead and add this next change to the current modification as you respond to the contingency?

No, from the bottom of our hearts, we beseech you. Please don’t. Please limit yourself to just responding to the contingency and then submitting another modification after the current one is approved.

Why? Because although it might understandably seem more efficient to add additional changes in a contingency response, you’ll actually wind up slowing down the review and approval process. That’s because the original modification has already been routed through its various possible prereviews and through the IRB review process. Adding new stuff to the original modification runs a high risk of having to restart the whole modification review process — back to budget review, maybe back on a convened IRB agenda, etc. So resist the temptation to do anything than respond to the contingency.