{"templateJson":{"children":[{"dataId":148097,"name":"Section1","text":"(HRP204)","label":"Modification","type":"question","children":[{"dataId":148098,"name":"Label3","text":"<strong>GENERAL INFORMATION</strong><br><ul><li>For a Modification, Cayuse creates a copy of the last approved submission.&nbsp; </li><li>When there are changes to the study protocol, the PI should make the requested changes directly in the item/answer&nbsp;in each Section (as appropriate) and provide a summary below with a rationale for the change(s).</li></ul><strong></strong>","required":false,"helpText":"","label":"","type":"label"},{"dataId":212475,"name":"Group4","text":"<strong>Purpose</strong>","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":212476,"name":"CheckBox1","text":"<strong>I am requesting the following changes to the&nbsp;project.<br></strong>","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":148104,"name":"TextArea1","text":"<strong>Summary and rationale</strong>","description":"<ul><li><em>To guide the reviewer, please&nbsp;</em><em>list each change by Section,&nbsp;using the number formatting <u>and</u>&nbsp;provide the rationale for each change.&nbsp;&nbsp;</em></li><li><em>In some cases, the rationale may be global statement&nbsp;for all changes</em></li></ul><em style=\"background-color: initial; font-family: Arial, Helvetica, Verdana, Tahoma, sans-serif;\">For example,</em><ol><li><em style=\"background-color: initial; font-family: Arial, Helvetica, Verdana, Tahoma, sans-serif;\"><em style=\"background-color: initial;\">Study Personnel - Remove X and Add Y because X has changed positions</em></em></li><li><em style=\"background-color: initial; font-family: Arial, Helvetica, Verdana, Tahoma, sans-serif;\">Subjects - Change inclusion/exclusion criteria to remove X because of screen failures.</em></li><li><em style=\"background-color: initial; font-family: Arial, Helvetica, Verdana, Tahoma, sans-serif;\">Subject Numbers - Increase number from # to # because a higher than anticipated number of potential participants have not passed the eligibility screening.</em></li><li><em style=\"background-color: initial;\">XXX - to match RMU submission to local IRB submission.</em></li></ol><em style=\"background-color: initial; font-family: Arial, Helvetica, Verdana, Tahoma, sans-serif;\"></em>","required":false,"helpText":"Creating a Modification submission creates a copy of the Initial Submission (or most recent Modification)&nbsp;for you to edit as needed to indicate the requested changes.","label":"","type":"textarea","dependencies":[{"targetId":212476,"type":"displayed"},{"targetId":212476,"type":"required"}]},{"dataId":202476,"name":"Group2","text":"<strong>Have you made the&nbsp;change(s) listed above in each appropriate Section, changing radio buttons, checkboxes, and text boxes/areas as needed?</strong><br>","description":"<ul><li><em>Each change listed in the summary should also be made in the corresponding Section.</em></li><li><em>The reviewer will use a compare function to easily see the changes.</em></li></ul>","required":false,"helpText":"Cayuse creates a copy of the Initial Submission for each Modification Submission.<br><br>You may change your original choices/answers directly in the appropriate Section.","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":212476,"type":"displayed"},{"targetId":212476,"type":"required"}],"children":[{"dataId":202477,"name":"Radio6","text":"Yes<br><br>","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":212477,"name":"CheckBox2","text":"<strong>I am providing post-approval documents that could not be available until RMU approved the project.<br><br></strong>","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":212473,"name":"Group3","text":"<strong>Have you changed the appropriate Section(s), changing radio buttons, checkboxes, and text boxes/areas as needed?</strong>","description":"<ul><li><em>Each \"Letter of Support forthcoming; will be signed upon RMU approval OR Local IRB approval pending\"&nbsp;should be changed&nbsp;in the corresponding Section.</em></li><li><em>The reviewer will use a compare function to see the changes.</em></li></ul>","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":212477,"type":"displayed"},{"targetId":212477,"type":"required"}],"children":[{"dataId":212474,"name":"Radio4","text":"Yes<br><br>","required":false,"helpText":"","label":"","type":"radio"}]}]}]},{"dataId":148103,"name":"Label2","text":"<strong>If you did not choose at least one of the two choices above, please DO NOT&nbsp;make any changes in the sections to the left.<br><br>Back out and delete this Modification submission.</strong><br>","required":false,"helpText":"","label":"","type":"label"}]}],"attachments":[]},"samples":[]}