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

(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.


Outdated information below this line:

_________________________________________________________________________

Previous presentation about migration.

(Updated 11/18/2019)

  • User Testing ended last week! Thanks to all who volunteered!
  • **IMPORTANT** Hiatus on Continuing Reviews** - see below
  • Be Prepared: Strategic Slowdown in Submissions - see below
  • New Protocol Templates Required for Upgraded System - see below, and give us feedback

 

**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

 

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.

 

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!