Completing Study Shells
JHSPH IRB’s PHIRST SYSTEM(Public Health Institutional Review System Tracking)Completing Study ShellsFor Investigators, Students, Study Team Membersdeveloped byJohns Hopkins Bloomberg School of Public HealthInstitutional Review Board (IRB) Office615 N. Wolfe StreetSuite E1100Baltimore, Maryland sthelp@jhu.edu
Table of ContentsLog in to PHIRST . 3Your PHIRST Homepage – My Inbox . 4The Application Workspace . 5Application Questions . 5Who completes the application – PI or study team member? . 6Transitioning to Active – what now? . 716Dec20192
Log in to PHIRSTPHIRST is available at https://phirst.jhsph.edu. This address brings you to the PHIRST log in page. Clickon the blue button “Log in with JHED”, using your JHED ID and JHED password. If you need to refer toyour study in the old PHIRST system, click on the gray “Log into old PHIRST” button. Your user name isnow your JHED ID, but your password remains what it has always been for PHIRST.16Dec20193
Your PHIRST Homepage – My InboxWhen you log in to PHIRST; you will arrive at your PHIRST Homepage called My Inbox. All active studieson which you are listed as PI in the IRB will be listed under the blue New Application banner. Note thatthey are all in the “Pre-Submission” state. Be assured that they are all approved studies and they willnot have to go through the IRB review process again; we are simply moving them operationally frompaper to fully electronic. They must be submitted by you so the IRB can activate them in the updatedPHIRST system.Click on the study title to go to the study Application Workspace.16Dec20194
The Application WorkspaceMany application shells will be pre-populated with the following documents: Current approved research plan for the study Current approved consent/assent/parental permission form(s) if you have them for your study Several other documents may also be included depending on your studyThe documents will be found on the relevant application pages, i.e., consent documents will be on the“Informed Consent for Adults” page, assent documents on the “Assent for Minors” page, and so on. Youmust complete the application questions in order to submit the application to the IRB so that the studycan be transitioned into the approved active state.Click on “Edit Application” to go to the application questions.Application QuestionsThe first page of the application will have the study name, short description and PI already filled in. You,as PI, may add co-investigators, student investigators, other study team members and study contactnames. If they aren’t readily available in the drop-down list, don’t worry; the IRB has the paper file of allthe people you have added to your study to date. You can reconcile your list of study investigators andpersonnel at a later time.Your answers to PHIRST questions should reflect the current state of your study as of the last approval.Do not include information that has not yet been reviewed; THIS IS NOT AN OPPORTUNITY TO UPDATEOR MODIFY YOUR STUDY. You may later amend your study through the PHIRST system once your studyis active. You may upload any study document (instruments, permissions, etc.) that has already beenapproved by the IRB. (Instructions for uploading documents can be found in the PHIRST User Guide)16Dec20195
Who completes the application – PI or study team member?Although all application questions must be completed in order to submit, only the first page must becompleted by the PI. Other study team members, once added to the first page, may complete the restof the application.1. On the first page of the application, Study Team and Study Description, the PI adds current,approved study team members to either question 5.0 (co-investigator), question 7.0 (studentinvestigator) or question 8.0 (study contact).2. The PI completes the required questions on the first page (marked with a red * asterisk).3. The PI clicks “Continue” or “Save” at the top or bottom of the page.4. The added study team members can now log in to their PHIRST accounts and will see the applicationlisted on their My Inbox homepage under the Action Required tab.5. They complete the remaining pages of the application (and upload any additional documents) andalert the PI when finished.6. Only the PI can submit the application, either from the last page of the application (see below) orusing the “Submit to IRB” activity on the left side of the application workspace.16Dec20196
Transitioning to Active – what now?The IRB staff will review your submitted application to ensure that it is consistent with the approvedstudy file. They will then transition the appliction to “Active”. Once active, you will be able to submitamendments, continuing reviews, and all other submissions related to you study. All study submissions,including related documents will be available in PHIRST.For complete instructions on using PHIRST, you may refer to the PHIRST User Guide, available at the IRBOffice website. For questions specific to PHIRST, email the IRB PHIRST Help Desk atJHSPH.phirsthelp@jhu.edu. For other IRB questions, call the IRB Office at 410-955-3193, or email atJHSPH.irboffice@jhu.edu.16Dec20197
1. On the first page of the application, Study Team and Study Description, the PI adds current, approved study team members to either question 5.0 (co -investigator), question 7.0 (student investigator) or question 8.0 (study contact). 2. The PI completes the required questions on the first page (marked with a red * asterisk). 3.
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