{"templateJson":{"children":[{"dataId":2307920,"name":"Section1","text":"Modification","label":"","type":"question","children":[{"dataId":2307921,"name":"Label3","text":"<u style=\"font-weight: bold;\">Full Board & Expedited Studies:</u><br><strong><em>All </em></strong>changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures, data management/security,&nbsp;and funding.<br><strong></strong><br><strong><u>Exempt Studies:</u></strong><br><em><strong>Only</strong>&nbsp;</em>the following&nbsp;changes to the study <strong>must</strong> be reviewed and approved by the IRB prior to implementation:<br><ul><li>All Personnel changes</li><li>All Funding changes</li><li>If research involves protected health information (PHI): All data collection changes </li><li>Substantive changes</li></ul>What is a substantive change?<br><ul><li>A change that results in the study no longer qualifying to be exempt</li><li>Addition of participants from a vulnerable population (i.e. children, prisoners, cognitive impairment, etc.)</li><li>Change in sensitivity level of study by adding sensitive questions or changing to identifiable data collection procedures</li><li>Addition of physical or biomedical procedures</li><li>Addition of use of deception or incomplete disclosure</li><li>Removing consent process</li></ul>","required":false,"helpText":"","label":"","type":"label"},{"dataId":2307922,"name":"Group1","text":"Are you making amendments/changes to the project?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2307923,"name":"Radio1","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307924,"name":"Label1","text":"<strong>Please make your changes in the appropriate sections of your approved IRB submission&nbsp;to the left.</strong>","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2307923,"type":"displayed"}]}]},{"dataId":2307925,"name":"Radio2","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307926,"name":"Label2","text":"Please <strong>do not </strong>make any changes in the sections to the left. <br><em>This form is not required.<br></em><br>","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2307925,"type":"displayed"}]}]}]},{"dataId":2307927,"name":"Group3","text":"<u><strong>Modification Information</strong></u>","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2307923,"type":"displayed"}],"children":[{"dataId":2307928,"name":"Group2","text":"Who initiated the study amendment?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2307929,"name":"Radio3","text":"Local Study Team","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2307930,"name":"Radio5","text":"Lead Study Site","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2307931,"name":"Radio4","text":"Sponsor","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2307932,"name":"Radio6","text":"Other","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307933,"name":"TextBox1","text":"Please specify.","required":true,"helpText":"","label":"","type":"textbox","dependencies":[{"targetId":2307932,"type":"displayed"}]}]}]},{"dataId":2307934,"name":"TextArea2","text":"<br>Summary of&nbsp;the specific changes to be made:<br><br><em>Be as specific as possible when describing changes as this text will appear on your amendment approval letter.</em><br>","required":true,"helpText":"","label":"","type":"textarea"},{"dataId":2307935,"name":"TextArea1","text":"<strong>Justification</strong>","description":"<em>Please provide the reasons and/or rationale for the requested modifications.</em>","required":true,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2307923,"type":"displayed"}]},{"dataId":2307936,"name":"Group4","text":"<br><u><strong>Changes to Risks<br></strong></u><br>Will this amendment increase the current level of risk, discomfort, or inconvenience subjects may experience in this study?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2307937,"name":"Radio7","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307938,"name":"TextArea3","text":"Please provide a detailed explanation and describe what steps will be taken to minimize these risks:","required":true,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2307937,"type":"displayed"}]}]},{"dataId":2307939,"name":"Radio8","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2307940,"name":"Group5","text":"<br>Are any of these changes the result of something that occurred during subject interaction or as an unexpected problem and/or adverse event?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2307941,"name":"Radio9","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307942,"name":"TextArea4","text":"Describe the event(s) and its' impact of the subjects in the study:","required":true,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2307941,"type":"displayed"}]}]},{"dataId":2307943,"name":"Radio10","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2307944,"name":"Group6","text":"<br><u><strong>Subjects<br></strong></u><br>Have any subjects been enrolled in this study?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2307945,"name":"Radio11","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307946,"name":"Group7","text":"Do these changes involve information that might be related to a subjects' willingness to continue to take part in the research project?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2307945,"type":"displayed"}],"children":[{"dataId":2307947,"name":"Radio13","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307948,"name":"Group8","text":"Are there plans to re-consent enrolled subjects based on these modifications?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2307947,"type":"displayed"}],"children":[{"dataId":2307949,"name":"Radio15","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307950,"name":"TextArea5","text":"Please indicate how the appropriate information will be communicated to participants:","required":true,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2307949,"type":"displayed"}]}]},{"dataId":2307951,"name":"Radio16","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2307952,"name":"TextArea6","text":"Please explain why re-consenting will not occur:","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2307951,"type":"displayed"},{"targetId":2307951,"type":"required"}]}]}]}]},{"dataId":2307953,"name":"Radio14","text":"No","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2307954,"name":"Radio12","text":"No","required":false,"helpText":"","label":"","type":"radio"}]}]}]}],"attachments":[]},"samples":[]}