November 4, 2015

Hints to 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?

Below are some things we’ve noticed in CLARA submissions that may slow down your study’s IRB approval:

Tracking — When you submit revised protocols, informed consent forms, HIPAA authorization forms, or other documents, you must include versions that show what you are changing. You have two options here. In order of preference, they are: 1) Always use the “track changes” function in Microsoft Word to make changes. That way you can submit a single copy of the revised document, from which the IRB can create both clean and tracked-changes copies. OR 2) Submit two copies.  One would show all the changes made to the document, including deletions, preferably using the “track changes” function in Word. The other would 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). If you are using the two-separate-clean-and-tracked-versions option above, that means that once you submit revisions, you will have two different stacks of revised documents, one for the clean copies, and one for the tracked copies. Submitting a single version using the Word tracked-changes option means you only have one stack of each type of document. 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:

Wrong: IRB_protocol_revised

Right: Smoking Protocol V2 dated 11.4.15 clean

Right again: Smoking protocol V2 dated 11.4.15 tracked changes

Or, if you’re using single-copy option above: Revised smoking protocol V2 dated 11.4.15

Please use these tips, along with the help option in CLARA for guidance on how to submit documents in CLARA. The IRB will return any submissions That will slow down the overall review and approval process.