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NIH PROTECT Release Notes

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July 12, 2023, PROTECT Release Notes

Download a PDF version here.

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Heading	Attached documents must now be marked as active (or not)ALL Projects (IRB/RSC/SRC)\| New columns added to Dashboard’s ‘My Inbox’ and ‘My Reviews’ tab
ID	1PT23

In the IRB study form and Scientific Review form, for every document type, there is a new mandatory question that asks: Is this document active? Yes/No.

Documents that are “active” are those that are currently being used in the study. Documents that that are no longer “active” (inactive) are those that have been retired and no are longer in use, e.g., a consent document for a cohort that has been completed or a recruitment material that is no longer being used. For those types of documents, you should select “no” (not active).

The status of each document (Is Active? Yes/No) will be displayed on the Documents tabs of the IRB and SRC project workspaces as well so users may easily identify these as such. The status of each document will also be displayed in the IRB, SRC, and RSC applications wherever documents appear.

You can refer to this tip sheet that illustrates the process in PROTECT.

Accordion

Heading	Automatic notifications to remind the study team to submit a SR Quadrennial Review
ID	2PT23

PROTECT will now send notifications to the study teams to remind them to submit their Quadrennial Reviews. The ‘Quadrennial Due Date’ in the system is set behind the scenes as 4 years minus 1 day from the Initial Review's Approval Date. The system will use this date to send Quadrennial Review Reminder Notifications at 90, 60, and 30 days prior to this date.

Accordion

Heading	Scientific Reviews are now correctly appearing in the Chief Scientific Officer’s (CSO) Inbox
ID	3PT23

Previously, the CSO ancillary review group were not seeing the project in their Inbox when it was assigned in an approved state. This has been fixed so that it will correctly appear in their inbox regardless of the workflow state the project is in.

Accordion

Heading	The PI Proxy can now see the ‘Report Continuing Review Data’ and ‘Correspond with Site’ activities
ID	4PT23

For a multi-site study where NIH is the Reviewing IRB, PIs could see the ‘Report Continuing Review Data’ and ‘Correspond with Site’ activities but the PI Proxy could not. This has been fixed so the proxy now has these activities.

Accordion

Heading	The ‘My Reviews’ tab now shows only projects where the logged in user is assigned as reviewer
ID	5PT23

The My Reviews tab was working inconsistently and displaying projects where the user was not a reviewer on the project, making the tab not as helpful as intended. This has been revised so that the ‘My Reviews’ tab shows only projects where the logged in user is assigned as reviewer.

Accordion

Heading	When reviewers sign off on (Submit) the RSC and SRC ancillary reviews, a notification will now go to study teams
ID	6PT23

Previously, the study teams were not notified when the RSC and SRC ancillary reviewers Submitted Ancillary Reviews. They had to track this by looking on the Reviews tab for the project. The study teams (PI, Proxy(ies) and primary contact) will now also get an email notification when the RSC and SRC ancillary reviewers submit their ancillary review.

Accordion

Heading	Ancillary Reviewers’ Assigned Actions appear in inbox/my reviews tabs only after submission to IRB
ID	7PT23

Previously, once a study team member “managed an ancillary review” and added a reviewer (ex. DEC), the action would appear in the reviewers’ My Inbox tab. This was inconsistently occurring before the action was submitted to the IRB for review (in the pre-submission state) appearing that it was ready to be reviewed by the ancillary reviewer. The IRB ancillary reviews should not be initiated until the submission is complete and submitted to the IRB. IRB ancillary reviewers will now only see the action in their My Inbox/My Reviews tab once it has left the Pre-Submission state and been Submitted to the IRB.

Accordion

Heading	Actions no longer remain in ancillary review dashboard inbox if review not accepted
ID	8PT23

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Accordion

Heading	E-mail notifications for comments will now display the content of comment in the body of the email
ID	9PT23

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Accordion

Heading	Display protocol short title on SRC submissions
ID	10PT23

Previously, on the Scientific Review workspace only the IRB Parent Study number would appear in the heading. We have added the protocol short study title to also appear in the heading. The caption for the protocol number is updated to read “IRB Parent Study ID” and the protocol short title will be listed underneath the protocol number after the caption “IRB Parent Study Title”.

Accordion

Heading	Links to IRB Expedited Actions Report removed from SRC and RSC meeting workspaces
ID	11PT23

The IRB expedited actions report was displaying in the meeting workspace of SRC and RSC meetings. This link should not be visible to SRC and RSC members and does not need to be on these workspaces. We have removed the IRB expedited actions report from the SRC and RSC committee meeting workspaces.

July 12, 2023, PROTECT Release Notes

Download a PDF version here.

20PT23

We have added additional columns to the My Inbox and My Reviews tabs on the Dashboard. These new columns will provide additional information and make the submissions easier to identify from the dashboard. These were added to the “My Inbox” and “My Reviews” tabs of the Dashboard as well as the “My Inbox” tab of the IRB Central Staff Dashboard and the SRC Central Staff Dashboard. The additional columns added are:

PI Last Name
PI first name
IC (of PI)
Parent protocol expiration date

Accordion

Heading	ALL Projects (IRB/RSC/SRC)\| Submit Ancillary Review email notifications now go out for all follow-on submission types
ID	21PT23

When we turned on email notifications for IRB/RSC/SRC ancillary reviews in a recent release, they were only working on initial submissions. They are now working on all follow-on submission types (MODs, CRs, etc.)

Accordion

Heading	Scientific Review Project \| ‘Deferred’ outcome and workflow has been added
ID	22PT23

Users who are SR specialists or designated (expedited) reviewers will now be able to select an outcome of “Deferred” on the Submit Committee Review and Submit Expedited Review activities in the Scientific Review (SR) project. As such, when this outcome is selected, and the Deferred letter is sent to the research team using the Send Letter activity, the SR will transition to a new ‘Deferred’ state on the upper left-hand side of the workspace. This places the SR back in the research team’s court in an editable state where they may address the requirements from the SR and then submit back to the SRC so they may resume their review.

Accordion

Heading	Scientific Review Project \| SR projects that are “Waived” will not receive annual/quad review deadline reminder emails
ID	23PT23

One scenario was overlooked when considering when SRC deadline reminders should be sent - when SRs are waived, they do not require reminders emails to tell users to submit Annual or Quadrennial reviews. We have fixed this so that those are no longer sent if a determination of “Waiver Approved” is selected on the Submit Committee Review activity or Submit Expedited Review activity for any SR submission.

Accordion

Heading	Scientific Review Project \| SRC Specialists can now “Update Documents” for an SR meeting
ID	24PT23

SRC Specialists can now run the Update Documents activity on an SR meeting workspace, allowing them to add additional documents for the committee to review at that meeting. These documents will then appear on the Supporting Documents tab of the SRC meeting workspace.

Accordion

Heading	Scientific Review Project \| Display of documents in a SR MOD has been fixed
ID	25PT23

The documents displaying on the SR form with a MOD have been incorrectly displaying the IRB approved versions, not the documents updated on the existing MOD that is in process. This has been fixed so that the documents that are updated with the MOD will display in the SR MOD workspace.

NOTE: When we went live with PROTECT, we did not migrate any SRC or RSC projects from iRIS, only the IRB project. The first time you create any type of SR or RSC project in PROTECT, the system codes it as an "initial review" (even if it is a MOD/AR/QUAD review form). If the first SR project created in PROTECT is a MOD (such as in the case of a migrated study), the system will code it as an initial review, and documents updated in the MOD are not going to pull into the SRC form or Documents tab on the SR workspace for those actions. Users will need to go to the IRB MOD workspace/form to view the docs associated with this SRC MOD.

Eventually, this will not be a problem as an AR, at minimum, should be in the system for all protocols within one year, after which point this will no longer be an issue.

Accordion

Heading	IRB Project \| ‘Manage Guest List’ activity now available for Single Site External studies
ID	26PT23

Previously, the Manage Guest List activity was not available for Single Site External studies. This has been fixed and study teams should be able to run this now on all studies.

Accordion

Heading	IRB Project \| IRB ‘Unassigned’ tab now has accurate ‘Parent Protocol #’
ID	27PT23

On the IRB Project tab, Unassigned sub-tab there is a column called ‘Parent Protocol #’. This was Not displaying the IDs for all types of actions previously. This has now been resolved for all actions types except RNI.

Accordion

Heading	IRB Project \| IRB Meeting workspace agenda and printable agenda are in same order (IRB Staff Use Only)
ID	28PT23

Previously, the agenda items on the IRB meeting workspace and the agenda items that appear on the IRB meeting printable agenda and minutes documents were in differing orders, creating some confusion for IRB members and IRB staff when preparing for and conducting the meeting. These are aligned now so that the order of submission types being reviewed flow in the same order in both places now, making it easier for users to conduct their work before, during, and after the meetings. Also, this same order has been applied to the IRB Meeting Minutes to assist the staff with finalizing post-meeting activities.

June 22, 2023, PROTECT Release Notes

Download a PDF version here.

Div

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Accordion

Heading	Attached documents must now be marked as active (or not)
ID	1PT23

In the IRB study form and Scientific Review form, for every document type, there is a new mandatory question that asks: Is this document active? Yes/No.

Documents that are “active” are those that are currently being used in the study. Documents that that are no longer “active” (inactive) are those that have been retired and no are longer in use, e.g., a consent document for a cohort that has been completed or a recruitment material that is no longer being used. For those types of documents, you should select “no” (not active).

The status of each document (Is Active? Yes/No) will be displayed on the Documents tabs of the IRB and SRC project workspaces as well so users may easily identify these as such. The status of each document will also be displayed in the IRB, SRC, and RSC applications wherever documents appear.

You can refer to this tip sheet that illustrates the process in PROTECT.

Accordion

Heading	Automatic notifications to remind the study team to submit a SR Quadrennial Review
ID	2PT23

PROTECT will now send notifications to the study teams to remind them to submit their Quadrennial Reviews. The ‘Quadrennial Due Date’ in the system is set behind the scenes as 4 years minus 1 day from the Initial Review's Approval Date. The system will use this date to send Quadrennial Review Reminder Notifications at 90, 60, and 30 days prior to this date.

Accordion

Heading	Scientific Reviews are now correctly appearing in the Chief Scientific Officer’s (CSO) Inbox
ID	3PT23

Previously, the CSO ancillary review group were not seeing the project in their Inbox when it was assigned in an approved state. This has been fixed so that it will correctly appear in their inbox regardless of the workflow state the project is in.

Accordion

Heading	The PI Proxy can now see the ‘Report Continuing Review Data’ and ‘Correspond with Site’ activities
ID	4PT23

For a multi-site study where NIH is the Reviewing IRB, PIs could see the ‘Report Continuing Review Data’ and ‘Correspond with Site’ activities but the PI Proxy could not. This has been fixed so the proxy now has these activities.

Accordion

Heading	The ‘My Reviews’ tab now shows only projects where the logged in user is assigned as reviewer
ID	5PT23

The My Reviews tab was working inconsistently and displaying projects where the user was not a reviewer on the project, making the tab not as helpful as intended. This has been revised so that the ‘My Reviews’ tab shows only projects where the logged in user is assigned as reviewer.

Accordion

Heading	When reviewers sign off on (Submit) the RSC and SRC ancillary reviews, a notification will now go to study teams
ID	6PT23

Previously, the study teams were not notified when the RSC and SRC ancillary reviewers Submitted Ancillary Reviews. They had to track this by looking on the Reviews tab for the project. The study teams (PI, Proxy(ies) and primary contact) will now also get an email notification when the RSC and SRC ancillary reviewers submit their ancillary review.

Accordion

Heading	Ancillary Reviewers’ Assigned Actions appear in inbox/my reviews tabs only after submission to IRB
ID	7PT23

Previously, once a study team member “managed an ancillary review” and added a reviewer (ex. DEC), the action would appear in the reviewers’ My Inbox tab. This was inconsistently occurring before the action was submitted to the IRB for review (in the pre-submission state) appearing that it was ready to be reviewed by the ancillary reviewer. The IRB ancillary reviews should not be initiated until the submission is complete and submitted to the IRB. IRB ancillary reviewers will now only see the action in their My Inbox/My Reviews tab once it has left the Pre-Submission state and been Submitted to the IRB.

Accordion

Heading	Actions no longer remain in ancillary review dashboard inbox if review not accepted
ID	8PT23

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Accordion

Heading	E-mail notifications for comments will now display the content of comment in the body of the email
ID	9PT23

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Accordion

Heading	Display protocol short title on SRC submissions
ID	10PT23

Previously, on the Scientific Review workspace only the IRB Parent Study number would appear in the heading. We have added the protocol short study title to also appear in the heading. The caption for the protocol number is updated to read “IRB Parent Study ID” and the protocol short title will be listed underneath the protocol number after the caption “IRB Parent Study Title”.

Accordion

Heading	Links to IRB Expedited Actions Report removed from SRC and RSC meeting workspaces
ID	11PT23

The IRB expedited actions report was displaying in the meeting workspace of SRC and RSC meetings. This link should not be visible to SRC and RSC members and does not need to be on these workspaces. We have removed the IRB expedited actions report from the SRC and RSC committee meeting workspaces.

Div

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Usa div

class	usa-accordion

Accordion

Heading	ALL Projects (IRB/RSC/SRC)\| New columns added to Dashboard’s ‘My Inbox’ and ‘My Reviews’ tab
ID	20PT23

We have added additional columns to the My Inbox and My Reviews tabs on the Dashboard. These new columns will provide additional information and make the submissions easier to identify from the dashboard. These were added to the “My Inbox” and “My Reviews” tabs of the Dashboard as well as the “My Inbox” tab of the IRB Central Staff Dashboard and the SRC Central Staff Dashboard. The additional columns added are:

PI Last Name
PI first name
IC (of PI)
Parent protocol expiration date

Accordion

Heading	ALL Projects (IRB/RSC/SRC)\| Submit Ancillary Review email notifications now go out for all follow-on submission types
ID	21PT23

When we turned on email notifications for IRB/RSC/SRC ancillary reviews in a recent release, they were only working on initial submissions. They are now working on all follow-on submission types (MODs, CRs, etc.)

Accordion

Heading	Scientific Review Project \| ‘Deferred’ outcome and workflow has been added
ID	22PT23

Users who are SR specialists or designated (expedited) reviewers will now be able to select an outcome of “Deferred” on the Submit Committee Review and Submit Expedited Review activities in the Scientific Review (SR) project. As such, when this outcome is selected, and the Deferred letter is sent to the research team using the Send Letter activity, the SR will transition to a new ‘Deferred’ state on the upper left-hand side of the workspace. This places the SR back in the research team’s court in an editable state where they may address the requirements from the SR and then submit back to the SRC so they may resume their review.

Accordion

Heading	Scientific Review Project \| SR projects that are “Waived” will not receive annual/quad review deadline reminder emails
ID	23PT23

One scenario was overlooked when considering when SRC deadline reminders should be sent - when SRs are waived, they do not require reminders emails to tell users to submit Annual or Quadrennial reviews. We have fixed this so that those are no longer sent if a determination of “Waiver Approved” is selected on the Submit Committee Review activity or Submit Expedited Review activity for any SR submission.

Accordion

Heading	Scientific Review Project \| SRC Specialists can now “Update Documents” for an SR meeting
ID	24PT23

SRC Specialists can now run the Update Documents activity on an SR meeting workspace, allowing them to add additional documents for the committee to review at that meeting. These documents will then appear on the Supporting Documents tab of the SRC meeting workspace.

Accordion

Heading	Scientific Review Project \| Display of documents in a SR MOD has been fixed
ID	25PT23

The documents displaying on the SR form with a MOD have been incorrectly displaying the IRB approved versions, not the documents updated on the existing MOD that is in process. This has been fixed so that the documents that are updated with the MOD will display in the SR MOD workspace.

NOTE: When we went live with PROTECT, we did not migrate any SRC or RSC projects from iRIS, only the IRB project. The first time you create any type of SR or RSC project in PROTECT, the system codes it as an "initial review" (even if it is a MOD/AR/QUAD review form). If the first SR project created in PROTECT is a MOD (such as in the case of a migrated study), the system will code it as an initial review, and documents updated in the MOD are not going to pull into the SRC form or Documents tab on the SR workspace for those actions. Users will need to go to the IRB MOD workspace/form to view the docs associated with this SRC MOD.

Eventually, this will not be a problem as an AR, at minimum, should be in the system for all protocols within one year, after which point this will no longer be an issue.

Accordion

Heading	IRB Project \| ‘Manage Guest List’ activity now available for Single Site External studies
ID	26PT23

Previously, the Manage Guest List activity was not available for Single Site External studies. This has been fixed and study teams should be able to run this now on all studies.

On the IRB Project tab, Unassigned sub-tab there is a column called ‘Parent Protocol #’. This was Not displaying the IDs for all types of actions previously. This has now been resolved for all actions types except RNI.

Accordion

Heading	IRB Project \| IRB ‘Unassigned’ tab now has accurate ‘Parent Protocol #’
ID	27PT23

Accordion

Heading	IRB Project \| IRB Meeting workspace agenda and printable agenda are in same order (IRB Staff Use Only)
ID	28PT23

Previously, the agenda items on the IRB meeting workspace and the agenda items that appear on the IRB meeting printable agenda and minutes documents were in differing orders, creating some confusion for IRB members and IRB staff when preparing for and conducting the meeting. These are aligned now so that the order of submission types being reviewed flow in the same order in both places now, making it easier for users to conduct their work before, during, and after the meetings. Also, this same order has been applied to the IRB Meeting Minutes to assist the staff with finalizing post-meeting activities.

June 1, 2023, PROTECT Release Notes

...

Versions Compared

Old Version 43

New Version 44

Key

NIH PROTECT Release Notes

July 12, 2023, PROTECT Release Notes

July 12, 2023, PROTECT Release Notes

June 22, 2023, PROTECT Release Notes

June 1, 2023, PROTECT Release Notes