Overview | Getting Ready | Getting Help | More iRIS Info
The final phase of the roll-out of iRIS involves transitioning all of the "pre-iRIS" studies into iRIS. This process will require extra effort on everyone’s part, but the final outcome will yield significant benefits to the research community. Details about this process follow. Please read all of the information and plan ahead to avoid lapses in study approval.
- "Pre-iRIS" studies are those that were originally submitted and approved outside of iRIS (i.e. submitted in PATS or via paper forms).
- Migration is the process through which "Pre-iRIS" studies will be transferred to iRIS.
- Migration Completion Form (MCF) is an electronic iRIS form that researchers will use to enter information about their study's current status and to attach study documents to activate their study in iRIS.
- Migration Mini Application (MMA) is an electronic iRIS form that researchers will use to review and complete their study's record in iRIS. It will be electronically attached to the MCF for submission to the IRB.
- Materials are all the documents you submit related to an approved study and include amendments, progress reports, reportable events forms, etc.
Migration began in March 2015 and involves two basic steps.
- The IRB pre-populated information about your study in iRIS. This includes:
- Study data: IRB #, PI Name, Study Title, approval dates, drugs, devices, etc. Some Key Personnel names will be populated as well
- Consent and HIPAA forms (PATS studies only)
- Researchers will complete their study records in iRIS. Detailed guidance, training, and assistance will be available. A Migration Handbook (available for download in iRIS) will also be available. A summary of the steps follows:
- Complete the Migration Mini Application (MMA):
- Review the pre-populated data and enter any data that was not pre-populated for you (e.g. protocol sites, sources of support details, accrual information, drug & device details, etc. as applicable to your study)
- Review/update the list of Key Personnel and Study Contacts (Reminder: CITI requirements apply to all Key Personnel and COI requirements apply to Investigators)
- Review any migrated consent and HIPAA forms (PATS/EAST Campus studies)
- Complete the Migration Completion Form (MCF) and
- Attach the MMA (already completed above)
- Attach/revise consent and HIPAA forms
- Upload the current protocol
- After completing the MCF, you will submit it (electronically, the same way as other iRIS materials). iRIS will notify the PI to sign off electronically. Once signed, the MCF will undergo CITI and COI verification and be administratively reviewed by the IRB staff.
- Once the MCF is approved by the IRB your study will be activated in iRIS and you will be able to proceed with submissions in iRIS.
Now that migration is complete, all materials must be submitted via iRIS going forward. Exception: If you are ready to close your study (all research activities including data analysis are complete) and you have not yet submitted an MCF, you may submit a paper Final Close-out form to close your study.
In order to prepare for completing the migration of your studies, the Einstein IRB recommends you do the following for any studies you plan to keep open:
- Ensure your study records are organized so that you will be able to quickly verify/look up any information needed for completing the migration process.
- Verify that each of the Key Personnel and Administrative Contacts have YUAD accounts. If any do not, submit a request now.
- Make sure all Investigator level Key Personnel complete and maintain a current electronic COI disclosure.
- Make sure all Key Personnel have satisfied the Basic CITI requirement.
- Drug/Device studies: Make sure all Key Personnel have satisfied the GCP requirement (and if it was satisfied via any course other than CITI, that documentation has been forwarded to Carmen Garcia).
- Locate an electronic copy of the study protocol.*
- West Campus studies: Locate an electronic copy (preferably in Word format) of the currently approved informed consent form(s).*
- West Campus studies: Locate an electronic copy (preferably in Word format) of the currently acknowledged HIPAA Authorization Form(s).*
*If you are unable to locate any of these files, please contact the appropriate IRB office (East or West), specifying the IRB number and the documents needed. We will be able to provide PDFs upon request.
Migration is a complicated process and the IRB understands that the research community is very busy. This is why we have been working hard behind the scenes to prepare for this event. We are also here to help you. We encourage you to attend a regular iRIS training session (and notify the presenter that you'll be working on migrating studies). You may also make an appointment with Paula at firstname.lastname@example.org.
If you have any questions please contact iRIS Support by email or phone (718-430-2776)
More iRIS Information
The process of transitioning to the new iRIS software will require extra effort on everyone’s part, but the final outcome will yield significant benefits to the research community. As we move forward, to assist with the transition, there are user guides, optional training sessions, and one-on-one assistance.
- Some of the many features and benefits of iRIS include:
- Paperless submission (all study documents are attached electronically and submitted through the software).
- Streamlined submission process.
- Electronic signatures (applications can be routed to PIs and chairs for electronic sign-off/approval).
- Dynamic application form (presents relevant questions based on the answers you provide).
- Multiple browser support (iRIS can be accessed using most browsers from PCs and Macs).
- Easy access to consents (all approved (stamped) consent forms and other study documents will be easily accessible in iRIS).
- Single portal access (post transition, researchers will be able access all of their Einstein IRB (East and West) research protocols in one place)
- Full board protocols will be assigned to the next available meeting (24/year).
For information on how to access iRIS, please visit the iRIS FAQ.
User guides/handbooks are available for download within iRIS.
Register for an iRIS Training Session.