Presentation on theme: "iStar How to Create an Amendment"— Presentation transcript:
1iStar How to Create an Amendment iStar Basics Training CourseFor Investigators and Study Staff
2Overview 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.
3In iStarYour 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.
4What 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 changesConsent form changesChanges in study personnelAddition of recruitment flyers and materialsChanges in funding sourcesSubject recruitment changesiStar only allows ONE amendment to be in process at a time.
5Start an AmendmentStudy must be approvedSelect to start an Amendment
6Example: Change Study-Coordinator From previous slideSelect ‘New Amendment’ button on the left-hand sideThe first screen of the amendment application will open.
7Example: 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 1.4Click Save on the gray barPage will refresh and select Exit on the gray barAn amendment will go into ‘Copy’ state for several minutes, you should refresh Amendment page after 10 minutes
8Parts of an iStar Amendment The Amendment ApplicationServes as the cover letter explaining what was changed in the study and why.To edit the amendment application, click theicon on the left.The Modified Study ApplicationAn 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
9Example: Change Study-Coordinator cont’d When Amendment finished the ‘copying’ process,Select button to continue your amendmentGo to next page by clicking on ‘Continue>>’Click on ‘Select’ and search for new Study CoordinatorORAdd a Study Staff (i.e., old study coordinator, team member that no longer needs access to the study) to be removed from the study
10Example: Change Study-Coordinator cont’d On the last SmartForm screen, select ‘Finish’ buttonOR
12Edit Modified StudyOn the Amendment Workspace, select to modify the study.MUST DONeed to make modifications on the study to take affect on the changes/updates stated in the ‘Edit Amendment’ part of the Amendment
13Edit Modified StudyGo 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.
14Edit Modified Study When you are done modifying , select ‘Save’ and then ‘Exit’ to get back to the Amendment Workspace.
15Submitting 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.
16How 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.
17Production Information Official Site:Mandatory Use for all New Studies
18Training Resources All resources found under Training Resources Application QuestionsUser Guide for InvestigatorsInformation “Quick” Sheets“Sandbox” Mode (Training Site)
19Where To Get Help IRB Office: Content questions Technical Support: Yana Gorelik – iStar Technical Support(323)Martin Koning Bastiaan - iStar Director(323)We welcome all Questions & Comments