iStar How to Create an Amendment iStar Basics Training Course For Investigators and Study Staff http://istartraining-chla.usc.edu

Overview User Roles: All user roles. Purpose: Detail what the iStar amendment application is and the types of study modifications that will require this application to be submitted. Outline some of the steps needed to complete an iStar amendment submission. Note: At this time, iStar only supports the submission of iStar amendments for studies already approved in iStar.

In iStar Your study file consists of 1) the study application, 2) all the attached documents in the application (i.e., consent forms, flyers, protocol), and 3) the history log, reflecting all the correspondence and action letters. Only the study team members have the rights to change/modify the study application or attached documents. When the study is returned to you during the initial review process, iStar automatically allows you to edit or modify the study file. However, once the study is approved, the study team is no longer allowed to edit the study file directly, since this represents the most current and accurate version of the study application and details.

What can you do in Amendment? To make ANY change or modification to any part of the study application or attached documents, the study team must submit an iStar amendment. Examples of changes that can be done through amendment: Protocol changes Consent form changes Changes in study personnel Addition of recruitment flyers and materials Changes in funding sources Subject recruitment changes iStar only allows ONE amendment to be in process at a time.

Start an Amendment Study must be approved Select to start an Amendment

Example: Change Study-Coordinator From previous slide Select ‘New Amendment’ button on the left-hand side The first screen of the amendment application will open.

Example: Change Study-Coordinator cont’d Enter an identifier for the amendment (1.1) Check Study Contact Person or Coordinator (1.2) Check None of the above will be revised or added (1.3) Select ‘No’ for question 1.4 Click Save on the gray bar Page will refresh and select Exit on the gray bar An amendment will go into ‘Copy’ state for several minutes, you should refresh Amendment page after 10 minutes

Parts of an iStar Amendment The Amendment Application Serves as the cover letter explaining what was changed in the study and why. To edit the amendment application, click the icon on the left. The Modified Study Application An exact copy of the approved study application (the working document for the study) that allows you to make your changes and modifications. All changes to the study MUST be made in the modified study application to take affect. To edit the modified study application, click the

Example: Change Study-Coordinator cont’d When Amendment finished the ‘copying’ process, Select button to continue your amendment Go to next page by clicking on ‘Continue>>’ Click on ‘Select’ and search for new Study Coordinator OR Add a Study Staff (i.e., old study coordinator, team member that no longer needs access to the study) to be removed from the study

Example: Change Study-Coordinator cont’d On the last SmartForm screen, select ‘Finish’ button OR

Amendment Workspace Summary Panel Tabbed Area Left-hand column

Edit Modified Study On the Amendment Workspace, select to modify the study. MUST DO Need to make modifications on the study to take affect on the changes/updates stated in the ‘Edit Amendment’ part of the Amendment

Edit Modified Study Go to a section where you can change ‘Study Coordinator’. This section called ‘Study Personnel (for a study already submitted to the IRB)’. Click on to choose a new Study Coordinator (see iStar.pps slide show for reference how to do single person selection). Reset button is only if you want to remove a current coordinator and do not have a new one. If under ‘Edit Amendment’ you have specified to update other parts of the study, then before exiting from Edit Modified Study you should go to the other pages and update them as well.

Edit Modified Study When you are done modifying , select ‘Save’ and then ‘Exit’ to get back to the Amendment Workspace.

Submitting the Amendment Final step: NOTE: If the Amendment was to add co-investigators, then ‘Send Co-Investigator Instructions’ needs to be sent out. A new co-investigator that is added to the study needs to ‘Agree to Participate in the Study’ before submitting an Amendment to IRB. Must select ‘Submit to IRB’ for the Amendment to be submitted to IRB Administrators.

How do I know if my Amendment has been Submitted? State of the Amendment has changed from ‘Pre-Submission’ to ‘Awaiting IRB Administrator Assignment’. You have ‘History’ that it has been submitted, by whom and when.

Production Information Official Site: http://istar-chla.usc.edu Mandatory Use for all New Studies

Training Resources All resources found under Training Resources Application Questions User Guide for Investigators Information “Quick” Sheets “Sandbox” Mode (Training Site)

Where To Get Help IRB Office: Content questions Technical Support: Yana Gorelik – iStar Technical Support istar@usc.edu (323) 276-2238 Martin Koning Bastiaan - iStar Director martin.kb@usc.edu (323) 276-2232 We welcome all Questions & Comments