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  4. Hints for completing the “lay summary” CLARA question

Hints for completing the “lay summary” CLARA question

The CLARA new submission form will ask you to provide a “lay summary” of your study. Please take some time to draft a complete, short, non-scientific-reader friendly study description in response to this question. Do not cut and paste protocol text, as protocols are written for other scientists. Nor should the answer be limited to a one-sentence description of the study aims. Instead, summarize the study aims, what you plan to do in the study, and who the target population is.

Example: This study will assess whether an educational program will help people lose weight in advance of open heart surgery. We will recruit participants from the UAMS cardiology clinic. We will randomize participants to receive either their standard care or their standard care plus a weight loss intervention. The intervention will consist of printed educational materials, a weekly online meeting with a nutrition coach, and a weekly phone call with a study team member. We will compare the two groups at the end of the study to see if one group loses more weight than the other.

Incorrect responses to this lay summary section could result in a contingency sent back to the study team for correction.

Posted by Edith Paal on June 12, 2024

Filed Under: Blog, Institutional Review Board Members, Research News

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