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  4. Updating your study? You may need to revise some form responses as well

Updating your study? You may need to revise some form responses as well

A reminder when submitting modified documents, or when responding to contingencies — if the changes you are proposing relate to something that was asked on the new submission form, please edit the corresponding modification form response to match your changes.

Example: Say that when you first proposed the study, you were going to provide compensation to subjects using checks mailed at the end of study participation. So you described the mailing of checks in the new submission form question that asked about compensation, and also described it in the consent form and protocol. Then, as the study progressed, you decided you’re going to give people a gift card at their last study visit instead of making them wait for a check. So you revise your protocol document and your consent form using a modification form. In addition to uploading the revised documents, please make sure to get back into the “subjects” section of the modification form to change the text describing the compensation plans.

Posted by Edith Paal on March 30, 2017

Filed Under: Research News

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