eIRB Upgrade News

The eIRB submission system is being upgraded! Same vendor, better platform.

  • Improvements in design and workflow, but it will also look familiar
  • Development and data migration are a big job
  • You will be impacted, but we have planned intensively to minimize disruption
  • This page is to help prepare you, the users. Also, view and share this summary PPT.

Latest Information (2/12/2020)

Upgraded System Available Now!
The upgraded submission system has been launched. Please access the new system here. Remember to use our new required protocol templates (under the Protocol Guidelines header) and consent form templates when submitting a new study.  Thanks to all our system testers, our research teams for their patience and collaboration during this process, our partners at ORA-IT and LITS, the vendor, and especially our IRB staff who have been so diligent in processing research submissions to ensure this migration was a success!

Modifications to Migrated Studies: Things You Should Know

When you submit your first modification to a study that migrated to the new system, you will be prompted to go back and fill in required fields that did not transfer directly from the old system.
Anticipated required information will include:

  • The five required questions on the last smartform page
    • These are yes/no response questions about waivers and ancillary reviews. Your answers should be consistent with the smart forms in the old system. See the snapshots of your prior smart forms under the Documents tab, to guide you
    • This includes one random question about expanded access drugs/devices near the end of the page, which we did not mean to make required; this will be fixed ASAP
  • Conflict of Interest attestation for each staff member on the study
    • This will only be required when making staff changes in a modification, but allow for extra time when submitting staff changes on studies with a large team!
  • Drug or Device attachments (IND/IDE letters, IBs, etc.), if applicable
    • This information was captured in a snapshot of the old system but still needs to be manually entered in the new system, unfortunately
  • Lay summary, if none was migrated

Submission Numbering in the New System
Migrated studies will maintain their previous study number from the old system. New study submissions will have a new numbering format.
Remember to update other ORA offices with this new number, if your study was created but withdrawn in the old system and re-submitted in the new.
Even for migrated studies, all follow-on submissions, including modifications, continuing reviews, Mod/CR pairs (yes, that’s a thing now!) and Reportable New Information (RNIs) will each be numbered sequentially starting at 1 in the new system. Due to differences in the formatting of the new system’s numbers (CR001 instead of CR1, for example), and the new terms for modifications and RNIs, it should still be easy to track how the submissions were approved chronologically, for regulatory purposes.


Need Help Using the New System?
If you’re having trouble navigating the new system, check out our how-to videos, and be sure to see the Page-Level Help on our IRB website, with guidance for each smartform question. If you still have a question or would like to set up a time for training (either individually or as a department), please email us to request assistance. We will use Zoom to provide training so that we can share screens easily for demonstration or troubleshooting. Please be prepared to use Zoom for your help session on a screen big enough to be able to view your help session!

Reminder: IRB Analysts Cannot Make Updates in the New System on Your Behalf
Just as a heads up, the functionality to edit smart forms or upload documents into submissions on behalf of study teams has been removed in the new system. The staff will have to request changes so that study teams can make the necessary updates. Please contact your study analyst to return a submission to you if you spot a correction that needs to be made and remember to submit your changes back when you’re done! Please also be careful when submitting close-outs, because the ability to re-open closed studies has gone away as well.

If A Study Is Closed-Out, It’s Closed-Out for Good…
In the old eIRB system, we could go back to an already closed-out study and re-open it for a study team, in extenuating circumstances. Our new system does not allow for this, so if your study is closed out in error, you will have to submit a new eIRB submission. Make sure you review our closeout page-level help for more information.

New Guidance: Reportable New Information Decision Chart
We have a new decision chart to help you decide whether a study event is required to be reported to the IRB via a Reportable New Information submission. The guidance includes decision trees for safety events, the loss or mismanagement of identifiable information, subject complaints, protocol deviations, consent process errors, errors involving drug administration or REMS requirements, and submissions requested by a study sponsor that are otherwise not reportable.

Latest information (2/7/2020)

The first wave of data migration was successful!

  • Our “new eIRB” is expected to go live on Wednesday, 2/12.
  • Your existing studies will either have been migrated during the Upgrade, or not (depending on where in review process it was)… How can you tell?
  • If Migrated: you will see a big red "Migrated" banner on your study in the "old eIRB" and most activities will be disabled.
    • All modifications, renewals, etc. must now be submitted in the “new eIRB.”
    • Note on Staff Change Requests: The “new eIRB” is not compatible with the Staff Change Request Tool we have been using. Instead, there are “staff change only” Modifications. These will be processed quickly by dedicated staff members, and will not prevent you from creating and submitting another type of Modification.
  • If Not Migrated: you will not see a red banner. Your study will be migrated at a later date, within 3 months.
    • You may continue to submit amendments/reportable events/etc. in “old eIRB.”
  • Note: Migration cannot be 100% comprehensive, despite all efforts. Some smartform questions will need to be back-filled at time of next amendment.

We have administratively withdrawn most items still in the “Pre-submission” state to prepare for the upgrade and data migration.

  • Withdrawn New Studies: must be created in the new system, using required templates. We have smartform previews available. See this webpage.
    • Important ORA plea: If your withdrawn study’s eIRB # was already provided to RAS/OCR/etc. for tracking, please update them with your new study number when you re-submit.
  • Withdrawn Follow-on Submissions (amendments, etc.):
    • If the parent study migrated, must be recreated and submitted in the “new eIRB.”
    • If parent study did not migrate, ask IRB analyst to un-withdraw if still needed.

The Emory IRB hosted a webinar on 2/6 entitled “Going Live! Time for the eIRB Transition.” It provided more information about the data migration process nad included tips and tricks for using the new system.We highly encourage you to attend or watch the recording on our Webinars page when time permits.  

Helpful Links:

 

Older information below this line ________________________________________________________________________

News from 1/31/2020

Page Level Help ready!

Our page level help that will assist you with your submissions is ready for your review.  You can find the information in this link.  Let us know if you have any comments or suggestions!

Freeze on new submissions
Starting Monday Feb 3rd, the IRB will need to withdraw any new submissions of studies, amendments, and continuing reviews. This is so that data migration can go smoothly. Please prepare to resubmit when our new system goes live on February 12th, using our new rrequired protocol and consent templates.

Withdrawal of some existing submissions
Beginning on Feb 6th: If your new study, amendment, or continuing review is in “Changes Required by IRB Staff” without action for over a couple of weeks, IRB staff will withdraw so that it does not interfere with study migration. (Note: if any ancillary approvals were already received, the IRB staff will ensure that is reflected in the new system after submission.)

If any item is still in Pre-Submission state as of Feb 5th, it will be withdrawn and you must re-submit in the new system.

If your study is not migrated at the time of upgrade…
Only fully approved studies with no open follow-on submissions (modifications, renewals, REs…) can be migrated during the upgrade. Any studies not migrated initially will be approved in our current system and will be migrated at a later date. Stay tuned for more details on timing.

Staff-Change Request Process is Changing
As shared in our fall webinar series, the new system is not compatible with our current Staff-Change Request Tool. The online tool will be closed starting on 5 pm on Feb 4th, until go-live on Feb 12th. Only studies that do not migrate to the new system at go-live can resume using the Staff Change Request tool after Feb 12th, until they migrate at a later date. Once a study is migrated, all staff changes will need to be submitted through a special modification (amendment) in the new system.

  • To mitigate impact, dedicated IRB staff will process these modifications
  • Modifications will not require PI sign-off if he/she has identified a proxy for submission
  • Staff-change-only modifications allow for another modification to be open at the same time!
  • We are still looking at other ways to minimize delay

 

Lastest Information (1/24/2020)

  • Starting today, every attempt should be made to hold any submissions including new studies, amendments and continuing review until go-live on 2/12/2020.  If you have submitted a new application, your analyst will ask you for the reason why your submission cannot wait.
  • For reportable events: if you learn about a new event after 1/30/2020, please submit it in the new system on 2/12/2020. You still will be in compliance.  Our new RNI smartform is posted under our eIRB upgrade page so you can start preparing your submission
    • In-Process REs- we’ve received new information that open RE submissions will delay study migration. Your Q team analysts are well aware and are working diligently to wrap up open submissions. We will contact you if any action is required on your part.
  • Staff changes: The current process of using the online tool will be available until 2/4/2020 at the end of business. We will cease processing these requests from 2/4/2020 after 5 pm until go-live on 2/12/2020. After go-live, studies that were migrated will need to submit an amendment for staff updates.  We will still allow the use of the online tool for studies that did not migrate before go-live.
  • Protocols: We have published new versions of the protocol templates after receiving input from investigators.  Please let us know if you encounter any issues.  We have a short video to help you with the use of our new templates.
  • Consent Forms: We have published new versions of all our consent form templates to be used for studies submitted after go-live (labelled “Saas…”.
    • You are not required to immediately update your consents if already approved by the IRB.  After go-live, any time your consents need to be re-stamped (modification or renewal) you will be required to remove the consent header.
  • eIRB Training:  we have new videos posted on our website.  Please review them and let us know if your group needs additional training or if you have any questions (note- these require a login with an Emory NetID and password).  We will also be offering training via Zoom after go-live (we will update the information on our website with those dates starting on February 3).

Lastest Information (1/9/2020)

The new dates of the strategic slowdown have been released!  The upgrade will start on February 6 at 5 pm until February 11, 2020.  The go-live new date is February 12, 2020.  We have released a paper copy of our smartform and updated our protocol templates

  • We will not accept any study submission during the upgrade period (2/6 to 2/11)
  • We are reviewing/approving all CRs submitted up to today (1/9/2020). After 1/10/2020: if your study expires after March 13, do not submit a CR (we will ask you to withdraw and submit in the new system)
  • No modifications will be accepted during the upgrade period.
  • Reportable events in review will not interfere with study migration

Studies not reviewed by IRB members before go-live

  • If an item is in Pre-Submission or Changes Requested by IRB Staff for over a couple weeks by 2/6/20 (the start of the upgrade), we will withdraw and you will need to resubmit in the new system
  • If new study is in Pre-Submission, or in Changes Requested by IRB Staff at go-live, you must re-submit in the new system
    • For ancillary reviews already done- we can ensure that the information is added to the new submission, so that effort is not lost
  • We agree this is not an ideal scenario - please, help us by responding to your study analysts so we can get your submission moving!

See our latest webinar recording for more information (presented on 1/9/2020).

Latest Information (12/23/2019)

We are very happy to announce that our upcoming strategic submission slowdown, to prepare for the eIRB upgrade, has been reduced from an anticipated three weeks to less than one week! Thank you to Emory LITS, ORA-IT, and the vendor Huron, for finding new ways to shorten the transition, and to Dr. Robert Nobles for his support!

 We will have more definite dates in the new year, but we wanted to share the good news before the break. Stay tuned for more details about what this means for you… but for now, hopefully it means less stress for your winter recess!

We also want to thank you for working so hard with us during this process, and to wish you a great holiday season, full of fun and happiness.

  • Be Prepared: Strategic Slowdown in Submissions - see below
  • **IMPORTANT** Hiatus on Continuing Reviews** - see below
  • New Protocol Templates Required for Upgraded System - see below, and give us feedback

Strategic Slowdown in Submissions

Here is what you can do to minimize the impact on your research…

Readiness of your submissions:

  • Rushing to submit before the slowdown may not save time, and may even require resubmission if the study not approvable in time for the last migration.
  • If your study can possibly wait, use the tools that will be on our website to prepare a great submission for once we go live.

Continuing review applications (CRs):

  • If your study expires during the submission slowdown or shortly thereafter, you will need to submit your CR as soon as possible. (If you waited until the new system went live, there would not be enough time to review.)
    The majority of studies expiring earlier than February 21st have submitted their CRs in the system – thank you!
  • We have updated the list of the studies affected on our website and will notify study teams via email.
  • If your study expires in late March and you have not yet submitted a CR, please wait to submit in the new system. We will process all of the CRs that have been submitted so far.

New study submissions – new strategic slowdown timeline (subject to further updates):

  • There is an estimated one week period where new studies will not be accepted in late January. Dates will be provided as soon as they are available. 
  • Studies still in review as of 1/24/2020 will not migrate in the first round – likewise any studies submitted during the slowdown. Once approved, they will await later migration.
  • In some situations, it may be advantageous to wait until after go-live and submit in the new system. Keep this in mind as you consider any last-minute new submissions in the coming weeks.
    • Will your study really be ready to start up once as IRB approval is secured? If not, please consider waiting for the new system.

Amendments:

  • New amendments will not be done via eIRB during the slowdown.
  • If they cannot or should not wait until the new system goes live: you will submit outside of eIRB (process to be finalized soon).
  • These amendments will have to be recreated in the new system, either by study team or IRB staff (to be determined).

New Protocol Templates Required for Upgraded System

The use of the new protocol templates is required for all new study submissions in the new system on the go-live date.

Why? Because the smartforms will be shorter!

We encourage you to start using them now! They are here on our website.

  • For Sponsor-created multisite protocols, you will need a supplement to a sponsor protocol template
  • This captures the Emory-site-specific information (e.g. local recruitment methods, data storage plans, etc.) no longer captured in smartform pages.

 

Previous information below this line:

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Latest Information

(12/11/2019)

Due to technical issues related to data migration, the go-live for our upgraded system is now estimated to be February 13 instead of January 31, 2020. This will shift the timeframe of our strategic slowdown (formerly January 7 - January 30th).

Here is what you can do to minimize the impact on your research…

Readiness of your submissions:

  • Rushing to submit before the slowdown may not save time, and may even require resubmission if the study not approvable in time for the last migration.
  • If your study can possibly wait, use the tools that will be on our website to prepare a great submission for once we go live.

Continuing review applications (CRs):

  • If your study expires on or before March 13, you need to submit a continuing review by January 6. (If you waited until the new system went live, there would not be enough time to review.)
    The majority of studies expiring earlier than February 21st have submitted their CRs in the system – thank you!
  • We have updated the list of the studies affected on our website and will notify study teams via email.

New study submissions – new strategic slowdown timeline (subject to further updates):

  • New studies will not be accepted after 1/24/2020 except for those that meet certain criteria
    If you submit a study after 1/24/2020 that does not meet the criteria, we will ask you to withdraw and hold it until the new system is up and running.
  • Studies still in review as of 1/24/2020 will not migrate in the first round – likewise any studies submitted during the slowdown. Once approved, they will await later migration.
  • In some situations, it may be advantageous to wait until after go-live and submit in the new system. Keep this in mind as you consider any last-minute new submissions in the coming weeks.
    • Will your study really be ready to start up once as IRB approval is secured? If not, please consider waiting for the new system.

Amendments:

  • New amendments will not be done via eIRB during the slowdown.
  • If they cannot or should not wait until the new system goes live: you will submit outside of eIRB (process to be finalized soon).
  • These amendments will have to be recreated in the new system, either by study team or IRB staff (to be determined).


Preparation for the Slowdown: Submissions Lingering in Pre-submission or “Changes Requested" Status

In preparation for the system upgrade, IRB staff will withdraw submissions that are still in Pre-Submission or in “Changes Requested” state for longer than 60 days before the slowdown. This includes amendments and renewals, as open submissions will prevent the parent studies from migrating.

If you need these items reviewed, submit them as soon as possible. Please note the warning above about open submissions delaying study migration.  If you need a withdrawn submission to be reinstated, please contact IRB Staff Leadership.  

Thank You for Submitting your Continuing Reviews Early!…

We still wanted to take a moment to thank you all for getting your continuing reviews submitted early! Your cooperation has been so wonderful, helping us prepare for the upcoming submission slowdown. Please know that IRB staff are working as quickly as possible to get all of these renewals reviewed, but the continuing review submission volume is much higher than normal. You may not see immediate action but know that we are working on it! 

As you read above, we still need more submissions for studies expiring through March 13, so we have saved this updated list on our website and will send a targeted email.

 

Previous presentation about migration.

(Updated 11/18/2019)

  • User Testing ended last week! Thanks to all who volunteered!

 

**IMPORTANT** Hiatus on Continuing Reviews** 

We need to stop processing continuing reviews during the migration slowdown period (see below).

To avoid a lapse in approval, you must do the following...

  • All studies expiring January/February 2020: Submit your continuing review ASAP
  • Are you affected? Review this list of expiring studies by PI.
  • Original deadline was 11/15 - if you missed it, submit anyway
  • You should have received an email reminder if you are associated with a study on the list

If you missed the deadline, we will do our best to reapprove your submission. We cannot guarantee approval before the upgrade.

IRB staff will proces the continuing reviews through the end of the year. You may not see immediate action, but know we are working on them.

If your study approval lapses, you will have to submit your CR in the new system AND stop all research until receiving reapproval (except procedures required to avoid harm to subjects - Contact the IRB if applicable).

Contact the IRB if you have any questions.

 

Be Prepared: Strategic Slowdown in Submissions 

  • Why? To enable efficient data migration. Only fully approved studies (with no open amendments/renewals) can be migrated.
  • When? January 7 through "go-live" around January 31
    • See above for continuing review deadlines
  • What?
    • New Studies: Limited to interventional studies with these criteria:
      • Competitive enrollment or contractual obligation for quick start-up (e.g. NCI grant)
      • IRB is limiting factor in start-up (i.e. do not submit if contract, etc. will not be ready)
      • Others: hold until new system go-live (consult IRB leadership if special concerns)
      • Any studies submitted: need to wrap up within 90 days of go-live, else must resubmit in new system
    • Amendments: only if updating protocol, IB, consents, or other study documents when immediate change is required by Sponsor or affects safety/welfare of subjects. Amendments for non-urgent changes should be held until go-live
    • Reportable events: Submit as usual in the current eIRB system
    • WIRB and other External IRB-Reviewed Studies: we will have another workflow available outside eIRB
    •  

Webinar: Update to Data Migration Schedule (9/12/2019)

See webinars page to view webinar on this. The latest information is posted above.

 

Data Migration Overview (7/29/2019)

Data/Study Migration is an important part of our System Upgrade project. This is where we move existing study information from the old to the new system. It is important that we can move away from our old system completely as quickly as possible. Data/Study migration is always a challenge, but our approach is designed to minimize downtime and minimize the impact on researchers.

How will we minimize the impact? First, by rehearsing the data migration process.  The first rehearsal will be completed at the end of July, beginning of August.  Second, we will institute a strategic “freeze”.

Why a “freeze”? To ensure data migration success.  Only fully-approved submissions can be migrated – nothing that is in the review process. During the freeze, the IRB will process existing items, so they can be migrated in subsequent phases.

How long will the “freeze” last? We are not yet certain of how long this “freeze” will be, or how we will ensure that new submissions are adequately reduced, but we will know more after the first migration rehearsal and we’ll let you know as soon as we can – both how long it might be, and later, when it will likely start.

What can you do to help? If your approved study will expire December 2019 or January 2020, plan to submit the continuing review application in early November. Submit new studies and amendments in November, or hold them until after the freeze, if at all possible. Reducing new submissions will maximize the amount of data that can be migrated in the first pass of data migration, and minimize additional work.   Your collaboration is important because that will help with the migration process, diminishing the amount of studies that are still in the old system at the time of the initial data migration.

 

Update on Progress (7/19/2019)

We are in the middle of technical implementation and our vendor is working hard on doing some testing to let us know more about the data migration timeline.  We will update our website when more information is available.

 

Preview of Changes (5/17/2019)

The IRB is actively working on updating templates, guidance and other documents that you will need when we launch the new eIRB system.  The documents expected to change would be as follows:

  • Protocol Templates
  • Checklist and Worksheets

We will not modify (or they will be minimally modified) our current Policies and Procedures and consent/HIPAA authorization forms.  

In addition, the IRB is working on monthly webinars to update you about the latest progress in this big project.  To find more information about our webinars, go to our webinar page.

 

eIRB Upgrade Announcement (4/30/2019)

The development process is intensive - so please bear with our staff as we attend many design sessions.

   The end result should be:

  • Streamlined submission forms for investigators (many fewer smartform pages!)
  • More robust help/guidance along with required protocol templates for investigator-initiated studies
  • Shorter forms for IRB Committee reviewers
  • Less burden on IRB staff and IT to maintain the system over time
  • Streamlined submission forms for investigators (many fewer smartform pages!)
  • More robust help/guidance along with required protocol templates for investigator-initiated studies
  • Shorter forms for IRB Committee reviewers
  • Less burden on IRB staff and IT to maintain the system overtime'

We hope to launch at the beginning of 2020

 Good news: the platform, from the same vendor as our current system (and the new eIACUC), will look quite familiar.  The launch will require a new submission freeze in our current system, as data is migrated. We will alert you well in advance when this is coming. This is the first major system overhaul we've done, and we hope it will keep us in good stead for years to come!