It’s the little things that will get your studies approved faster
Yes, the IRB looks at the big things when it reviews studies — are risks to subjects minimized? Are there appropriate provisions for obtaining the informed consent of subjects? etc. etc.
But the little things can also slow down your study’s trek towards IRB approval. Have you tracked your changes in revised documents? Are your documents stacked correctly in CLARA? Do they include the appropriate headers and footers? Are the document names entered correctly into CLARA?
A quick recap of issues we’ve noticed in CLARA submissions that may get your study sent back to you for correction before we even look at it:
Tracking — When you submit revised protocols, informed consent forms, HIPAA authorization forms, or other documents, please provide two copies of each. One copy should show all the changes made to the document, including deletions, preferably using the “track changes” function in Word. The other should be the clean copy with all of the changes accepted, again using the “track changes” function in Word. Make sure you have updated the version number and date in the footer as well.
Stacking — Revised documents are to be stacked upon the earlier versions of the same documents in CLARA, using the “upload revised version” link (with one exception — see below). All tracked changes versions should be stacked upon previous tracked changes versions (the one exception — for the first change, you would use the “upload new document” link to start a new stack, because there would be no previous tracked changes versions). All the clean versions should be stacked upon the previous clean versions. If you have made changes to your study documents, you should have two separate stacks (one clean, one tracked-changes) of each in CLARA, with the most recent version at the top of the stack. Clean and tracked-changes versions should never be in the same stack. If they are in the same stack, something has gone wrong and needs to be corrected before you finalize your IRB submission. See illustrated instructions in CLARA for how to manage documents by clicking on the following links after you log in: “Help,” and then, under “Protocols,” “Managing Documents.”
Headers/Footers — Please make sure all protocols, consent forms, and HIPAA authorization forms include a version number and date on each page, that it’s the same version number and date on all pages, and that you update the version number and date each time you make a change to the form in question. This version number and date is how we can tell which version is approved.
Naming documents in CLARA — The document name that you type into CLARA is the document name that will be included in your approval letter. The approval letter needs to clearly identify which documents it is referring to. Therefore, we need complete information in the study title that you enter into CLARA. Also, CLARA accepts spaces in document titles. So please don’t run all the title words together, or separate them with underscores or hyphens or anything like that; CLARA won’t display the titles correctly if you do. Please include version numbers and dates in your titles, and make sure the version numbers and dates in the titles match the ones that appear on the documents. Examples, using an imaginary study looking at the effects of smoking as a sample:
Right: Smoking Protocol V2 dated 11.4.15 clean
Right again: Smoking protocol V2 dated 11.4.15 tracked changes
If we have time in the IRB office, occasionally we’ll take it upon ourselves to correct the above issues in a submission. However, if we don’t have time, we have no choice but to send a study back to you before reviewing it with a contingency to correct these errors/omissions. That will slow down the overall review and approval process.