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