News Archives

You've asked and we've answered…

Revised IRB-required protocol templates – now without document protection! - available now on our website.

Reason: Document protection allowed IRB analysts to easily detect missing information in protocols, but some users had trouble editing them, protocols were often unnecessarily lengthened, and the templates weren't compatible with EndNote or other Word add-ins.

Solution: Each template is now unprotected so it can be edited freely. Instead, there's a required protocol checklist for each version of our protocol templates, to ensure no information was inadvertently left off.

Please upload these checklists as a separate document in your protocol section. These are required.

What if I already submitted using the old template? You are not required to use the checklists. However, if you revise your protocol and wish to use the new templates, you must attach the checklist the first time you submit the revision to the IRB.

You should use these forms going forward, but we will still accept older versions if you've already started drafting!

Reminder about eIRB Outage

The new eIRB will be offline from Friday, 4/10 at 5 PM EDT to Sunday, 4/12 around 6 PM EDT

Old eIRB is still unavailable at this time, but access should be restored soon

April 7, 2020

Tomorrow we hope to migrate the rest of old-eIRB studies into our new eIRB system!

Today we are working hard to wrap up all open items in the old eIRB. This includes new studies as well as follow-on submissions.

We have started to withdraw submissions that are still not ready for approval, as our earlier newsletters said might happen. We apologize for this. Rationale: given the small number of studies that remain in the old system, the high cost (in effort and money) of an additional automated migration would be out of proportion to the benefit, especially in these times of fiscal uncertainty. The migration process requires a team of FTEs and a couple weeks of work from both the vendor and Emory OIT.

There may be some studies for which we need to get creative with review and migration. Your analyst will communicate with you about that as needed.

Happily, the old eIRB will be available through the summer for reference only, so you can access materials for the new-eIRB resubmissions.

Timeline:

1. Tomorrow the migration will start at 2:30 PM EDT.
2. Once it begins, it will not be possible to log in to the old eIRB until late in the evening. The new eIRB will remain open during this week.
3. The new eIRB will be offline from Friday, 4/10 at 5 PM EDT to Sunday, 4/12 around 6 PM EDT

Thank you and please contact your analyst or our leadership with any questions.

Known issue with the New eIRB's "Devices" section (issue corrected 3/30)

Instead of the intended options, you will see a list of device names in Question 2 of the "Devices" section. This is an issue for New Studies and for Modifications to studies using devices. (See screenshot at the end of this message.)

Even if you select a device from the list, the error prevents you from moving forward.

The vendor is working on a solution. We will update you as soon as we know the repair timeline.

In the meantime, please do the following if modifying or submitting a study using a Device:

• Make sure you have copies of all of your device information
• Say "No" to the Device question in "Scope of Research," so the Device section does not appear
• Under "Local Site Documents," attach device information in a document, along with other device attachments.
  • Include, as applicable: name of Sponsor, IDE number, justification for IDE exemption, justification for non-significant-risk device (DOCX), and/or device instructions.
• Please log a comment to your analyst alerting them that you experienced this error and followed the above guidance. Thank you!

Brief Outage in New eIRB Tonight (3/3) at 11 pm

eIRB SaaS ("New eIRB") will be unavailable for about five minutes tonight beginning at 11:00 pm. Please remember to save all work prior to the outage. eIRB RX ("Old eIRB") will be unaffected by this brief outage.

eIRB Patch Delay Caused Inability to Create Modifications for Some

A longer-than-expected software process during the eIRB patch last Friday temporarily prevented users from creating modifications/CR's. This should now be remedied. Sorry for the inconvenience!

Submitting PI Changes in New eIRB

To change the PI on a study via modification, select "Other parts of the study" to have access to the first page of the submission. If you are changing the PI and other team members, select both options ("Study team member information" and "Other parts of the study").

Enrolling Non-English Speakers- A Matter of Equity

The IRB expects that all studies will include non-English speaking participants, unless there is justification to exclude them. Thus, please request to enroll non-English speakers in your protocol, via the use of the "short form" to obtain informed consent. Short Forms in many languages are available on our website. Please note: IRB analysts will ask for rationale for excluding non-English speakers going forward, if this population is not included in the protocol.

Help Us: Check Your Study's Expiration Date

Please help us by verifying that your study's listed expiration date is correct in new system. There have been some issues with studies' expiration dates not migrating at all or migrating incorrectly. If you notice a problem, please send us an email at irb@emory.edu.

Update on Submission Numbers

The last eIRB patch should have corrected the strange numbering for follow-on submissions (e.g. MODs/CRs). New follow-on submissions should restart numbering at 01 in the new system. Subsequent submissions will continue to be numbered incrementally. Unfortunately, strange numbering for in-process and completed follow-on submissions will remain.

Submit RNIs from Study Page When Possible

Please submit RNIs from the main study page to ensure that the RNI is appropriately linked to the study, rather than submitting an RNI from your main inbox page and later linking it to the impacted study. Submitting from your main inbox can cause some information to link incorrectly and this results in hiccups later in the RNI review process.

Outlook Thinks eIRB is Junk!

A small percentage of eIRB notifications may be going to your Junk or Spam mail folder. Some tweaks have already been made to help, and a more robust fix is in the works with the vendor. But for now, the fate of each eIRB notification that comes to you is slightly unpredictable. You can always go to "My Inbox" (or your review-related tabs, for IRB members) to see if anything new is waiting for you.

But Why is Rebecca Rousselle the Contact for Every Site?

Don't worry when you see Emory IRB Director Extraordinaire, Rebecca Rousselle, listed as the contact for all Emory sites. This was done intentionally because of a system requirement, and there is no need to try to correct this information (or to actually contact her).

Emory IRB Webinar on Study Closeout in New eIRB and Latest News

The IRB will host a webinar next Thursday, 3/12 at 12:00 pm entitled "Study Closeout in New eIRB and Latest News." The presentation will last approximately 20 minutes, including time for questions and answers. A link to the live webinar, as well as recordings of past webinars, can be found on the Webinars page of the IRB website.

Issue Resolutions for Migration and User-Permission

We are actively working on the following issues that have been raised since go-live, and some have already been fixed:

eIRB notifications are going to "Junk" folder

The send-from address for the new system notifications was not added to Emory IT's list of "safe" senders; IT is working with vendor to get this fixed.

Lack of expiration dates for some studies

Solution found, and affected studies will be updated within days, if not already.

Expiration dates are present for some "New Common Rule" studies that should not expire; may look lapsed

This was an issue from our old system - and we are now investigating the extent of these errors, with possibility of fixing them en-masse in new system. For now, IRB staff can log comments in studies to state that expiration date should not be present.

Worst case is that study team may need to submit a quick CR so that IRB staff can remove expiration date - stay tuned

Some studies should still be under the "Pre-2018" Rule (aka Old Common Rule) but are in new system as "2018" Rule (aka New Common Rule).

This was also an issue that carried over from our old system. See item directly above.

New MOD and CR identification numbers in the new system are oddly high

Solution found, and is being fixed in 2/28 patch for future submissions, but ones already in play will retain the oddly-high ID numbers

Many users unable to see their migrated External IRB studies

A fix was found and put in place! Let us know if you're still having any issues.

NOTE: All studies under external IRB review are in the big "IRB" tab under the "External IRB" sub-tab - they are NOT in your Active studies tab.
When clarifications are requested for new studies under external IRB review, they will still only appear in the "External IRB" tab, not your "My Inbox." We have put in a vote to change this with the vendor.

Past approval and pending-approval letters are missing from migrated studies

Solution in the works, and this will be rectified before our old system goes off-line in a few more months.
For now, access them in the old system.

Recruitment materials missing from migrated study "snapshots"

See directly above.

Not all known funding sources were pre-populated in the new system

List of additional funding sources has been compiled; will be imported into the new system ASAP. For now, work with your analyst re: whether funding should be added later or added ad-hoc by our IT colleagues immediately.

Some errors in the drugs that are listed in migrated studies

Solution for many has been found; studies without open modifications will be fixed automatically, but if there is a modification open, please enter the correct drugs as part of the modification

Other discrepancies may come up over time due to complexity of drug names in old system database; you can fix them via Modification

Local Research Location: Unable to add new location

An errant setting was to blame – this has been fixed and you should be able to now add a local research location like the Proton Therapy Center now.

Note: do not use this to add any institutions that have their own IRBs or FWAs – CHOA, VA, PTC, and Grady are the only ones we are considering "local" for now

Studies migrated as External IRB but should be local IRB, or vice-versa

Working on a solution for this (some were due to the short title starting with "NCI," we believe, which is also our nomenclature for NCI CIRB-reviewed studies)

Save Your Study Documents from the Old eIRB

Please save your approval letters and your recruitment materials from old eIRB. Some of these items did not migrate successfully. To be sure you maintain access to the documents you need, please save your documents. We hope to have these items migrated to the new system at a later date, but just to be safe, you should save your own copies!

"Update" or "Add?" How to submit revised documents in the New eIRB System

When submitting revisions to already-approved documents via a Modification, please do not use the "Add" function. Use "Update" instead, for the document being revised. See below:

Using "Update" has important benefits to you and the IRB…

• Allows for automated "track changes" – no need to upload your own track-changes version
• Version histories are tracked by the new system (viewable via the Document History in the image above)
• No need to indicate which versions are outdated

Stamping Consent Documents in New System at Renewal

When you submit a CR for a migrated study, be aware that the document stamp will look very different in the new system. Consider submitting a MOD/CR to remove the header in your approved ICF document to make sure it's compatible with the new system.

Reminder: New eIRB Can't Store Protected Health Information (PHI)

As a reminder, the new eIRB system (just like the old one) cannot be used to store or transmit protected health information. Please remember not to include any identifiers in anything you submit to the IRB. This is especially true in logged comments, which cannot be edited once they've been submitted and can be very expensive to modify.

Reminder: Emory IRB Protocol Templates Required in New eIRB

As a reminder, to ensure that the IRB has all of the information it needs right from the start of your submission:

• All investigator-initiated studies are required to use our protocol templates for new submissions in the new system.
• Sponsor-developed studies can submit the Sponsor's protocol, but must also submit our Supplement to Sponsor Protocol (DOCX).
• We hate to do it, but submissions without these templates will be sent back prior to further screening.

PI Proxies and Primary Contacts: How and When?

Only PIs can assign PI Proxies.

What are PI Proxies? These are people that the PI designates to submit responses to change requests, and to submit follow-on submissions (Mods, CRs, etc.) on their behalf. The PI is still responsible for the content of all of these submissions.

When can they be assigned, and how? This can be done at any time during the life of the study. It must be done via the "Assign PI Proxy" activity in the main study workspace.

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 OIT, 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 (PDF) 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.

The first wave of data migration was successful!

Our "new eIRB" is expected to go live on Wednesday, 2/12.

Existing Studies

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."

You can resume using the Staff Change Request Tool until the study is migrated.

Note: Migration cannot be 100% comprehensive, despite all efforts. Some smartform questions will need to be back-filled at time of next amendment.

Withdrawn New Studies: must be created in the new system, using required templates. We have smartform previews available. See .

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:

New templates and Smartform Previews

New System Training

Specific help for all new system smartform pages/questions

Page Level Help is ready!

Our page level help that will assist you with your submissions is ready for your review. You can find the information on the how-to page. 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 required 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

Hold Submissions

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 (mp4) 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).

New strategic-slowdown dates 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.

Not accepting submissions 2/6 – 2/11

We will not accept any study submission during the upgrade period (2/6 to 2/11)

CR Submissions

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)

Modifications

No modifications will be accepted during the upgrade period.

Reportable events

Reportable events in review will not interfere with study migration Studies not reviewed by IRB members before go-live

Items in Pre-Submission or Changes Requested

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

New studies in Pre-Submission or Changes Requested

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

Responding to Study Analysts

We agree this is not an ideal scenario - please, help us by responding to your Study Analysts so we can get your submission moving!

Latest Webinar

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

Reduced timeframe for Strategic Slowdown!

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 OIT, 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 smart-forms page.

• 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.

New dates for strategic slowdown and go-live

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 (PPTX).

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 working on continuing reviews

IRB staff will process 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/Study Migration

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.

Technical Implementation and Data Migration Timeline

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.

Updates to Templates and Other Documents

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

No Modifications

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

Webinars

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

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!