Appendix 1: Workflow
Workflow Steps – New Intervention / Interaction Protocol
Step # |
Step |
Workflow Action |
Results |
1 |
Submitter starts a new application and completes/saves the initial questionnaire. |
None |
Application is saved in Insight and can be viewed and accessed from the Work in Progress page. System presents submitter with the applicable forms to complete.
Status = In Progress |
2 |
Submitter has completed, successfully validated and submitted the application. |
None |
E-mail notification is sent to the PI with a link to Insight for the PI to accept and certify with electronic signature.
Protocol moves from Work In Progress page to Pending Applications page.
Status = Submitted |
3 |
PI certification and sign-off. (this task will involve the PI accepting participation on the study and also certifying within the same form) |
PI signs-off and certifies from their workflow queue and clicks ‘Accept’. |
E-mail notification is sent to the PI Department Chair and Site-PI (if applicable) for sign-off. The PI certification form will be attached to the PI’s entry on the Staff & Access page as a PDF for viewing and printing.
Status = Submitted |
|
|
PI does not sign-off or certify; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review. ** no contact people receive e-mail notification prior to PI sign-off
Status = Submitted |
4 |
If PI declines in step 3, the Submitter must take some action. The Submitter can either ‘Decline’ the changes the PI requested through his/her workflow queue with a note back to the PI or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 3 until PI has signed-off.
Status = Submitted |
5
|
If PI accepts in Step 3, then PI Department Chair must complete sign-off.
|
PI Department Chair signs-off from their workflow queue and clicks ‘Accept’.
The sign-off form is not saved as a PDF document; however the action of signing off is saved in workflow. |
If there are no additional sites, then the status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
If additional sites are on the study, then the protocol remains in ‘Submitted’ status until sign-off is complete. Step 7 would follow next.
|
|
|
PI Department Chair does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review. All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
6 |
If PI Dept Chair declines in step 5, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the PI Dept Chair requested through their workflow queue with a note back to the PI Dept Chair or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 5 until PI Department Chair has signed-off.
Status = Submitted |
7 |
If PI accepts in step 3 and there is an identified Site-PI on the protocol, then the Site-PI must complete certification and sign-off. (this one task will involve the Site-PI accepting participation on the study and also certifying within the same form)
This step is parallel with step 5. |
Site-PI signs-off and certifies from their workflow queue and clicks ‘Accept’. |
E-mail notification is sent to the Site-PI Department Chair for sign-off.
The Site-PI certification form will be attached to the Site-PI’s entry on the Staff & Access page as a PDF for viewing and printing.
Status = Submitted |
|
|
Site-PI does not sign-off or certify; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
8 |
If Site-PI declines in step 7, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the Site-PI requested through his/her workflow queue with a note back to the Site-PI or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 7 until Site-PI has signed-off.
Status = Submitted |
9 |
If Site-PI accepts in step 7, then the Site-PI Department Chair must complete sign-off. |
Site-PI Department Chair signs-off from their workflow queue and clicks ‘Accept’.
The sign-off form is not saved as a PDF document; however the action of signing off is saved in workflow. |
If Site is NWH, NSMC, or SRH, then E-mail notification is sent to Site IRB Chair. Protocol remains in ‘Submitted’ status.
If these sites are not included, once sign-off from the Site-PI Dept Chair is also complete, then the status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
|
|
|
Site-PI Department Chair does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
10 |
If Site-PI Dept Chair declines in step 9, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the Site-PI Department Chair requested through their workflow queue with a note back to the Site-PI Department Chair or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 9 until Site-PI Department Chair has signed-off.
Status = Submitted |
11 |
If Site-PI Dept chair accepts in Step 9 and NWH, NSMC, or SRH is included in the study, then the Site IRB Chair must complete sign-off. |
Site IRB Chair signs-off from their workflow queue and clicks ‘Accept’.
The sign-off form is not saved as a PDF document; however the action of signing off is saved in workflow. |
The status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
Status = Pending |
|
|
Site IRB Chair does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
12 |
If Site IRB Chair declines in step 11, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the Site IRB Chair requested through their workflow queue with a note back to the Site IRB Chair or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 11 until Site IRB Chair has signed-off.
Status = Submitted |
13 |
HRO Intake person pre-reviews the submission.
|
HRO Intake person clicks ‘Accept’. |
Based on answers to forms questions, routing to Ancillary review boards may be required. E-mail notification is sent to the point person for each Ancillary board with a link to Insight indicating that the protocol requires an Ancillary review.
E-mail notification is sent to all non-critical study staff with a link to Insight to sign-off.
For the HRO office, this is where workflow ends and current processes continue. Assignment to board will happen in ReX.
Status = Pending |
|
|
HRO Intake person clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Pending |
14 |
If HRO Intake person declines in step 13, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the HRO Intake person requested through their workflow queue with a note back to HRO Intake person or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 13 until HRO Intake person accepts.
Status = Pending |
15 |
Once HRO Intake person accepts in Step 13, then non-critical study staff can complete sign-off.
* This step is not certification. This is just the study staff acknowledging that they will or will not participate on the study. Only if they accept, then they will be given a task to certify.
|
Non-critical study staff members complete sign-off that they will be part of the study in their workflow queue and click ‘Accept’. |
E-mail notification is sent to non-critical study staff to certify.
Status = Pending |
|
|
Non-critical study staff members do not sign-off that they will be part of the study in their workflow queue and click ‘Decline’ with comments on why declining. |
No action at this time. *Members can be removed once the board reviews the application and unlocks it with ReqMod status.
Status = Pending |
16 |
If non-critical study staff members accept in step 15, then non-critical study staff must complete certification.
|
One or more non-critical Study staff members complete the certification form in their workflow queue and click ‘Accept’. |
The certification form will be attached to the study staff on the Staff & Access page as a PDF.
Status = Pending |
|
Non-critical study staff members do not complete certification.
|
One or more non-critical study staff members complete the certification form in their workflow queue and click ‘Decline’ with comments on why declining. |
No action at this time.
*Members can be removed once the board reviews the application and unlocks it with ReqMod status. |
17 |
Ancillary board point person must sign-off that they have received notification that an application requires review. |
Ancillary Board point person acknowledges that the protocol will require their review and clicks ‘Accept’.
|
E-mail notification is sent back to the HRO Intake person that the protocol has been Accepted.
NOTE: For Ancillary review, this is where workflow ends and current processes continue. Reviewer will notify the IRB via e-mail or fax of the outcome of the review. The board action and notes will be entered manually into Rex.
Status = Pending |
Workflow Steps – New Non-Intervention / Interaction protocol
Step # |
Step |
Workflow Action |
Results |
1 |
Submitter starts a new application and completes/saves the initial questionnaire. |
None |
Application is saved in Insight and can be viewed and accessed from the Work in Progress page. System presents submitter with the applicable forms to complete.
Status = In Progress |
2 |
Submitter has completed, successfully validated and submitted the application. |
None |
E-mail notification is sent to the PI with a link to Insight for PI to accept and certify with electronic signature.
Status = Submitted |
3 |
PI certification and sign-off. (this task will involve the PI accepting participation on the study and also certifying within the same form) |
PI signs-off and certifies from their workflow queue and clicks ‘Accept’. |
If there are no additional sites, then the status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
If applicable, E-mail notification is sent to the Site-PI for sign-off and protocol remains in a submitted status.
The PI certification form will be attached to the PI’s entry on the Staff & Access page as a PDF for viewing and printing.
|
|
|
PI does not sign-off or certify; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight for review. ** no contact people receive e-mail notification prior to PI sign-off
Status = Submitted
|
4 |
If PI declines in step 3, then the Submitter must take some action. The Submitter can either ‘Decline’ the changes the PI requested through his/her workflow queue with a note back to the PI or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 3 until PI has signed-off.
Status = Submitted |
5
|
If PI accepts in Step 3 and there is an identified Site-PI on the protocol, the Site-PI must complete certification and sign-off. (this one task will involve the Site-PI accepting participation on the study and also certifying within the same form)
|
Site-PI signs-off and certifies from their workflow queue and clicks ‘Accept’. |
If Site is NWH, NSMC, or SRH, then E-mail notification is sent to Site IRB Chair.
If these sites are not included, then the status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
The Site-PI certification form will be attached to the Site-PI’s entry on the Staff & Access page as a PDF for viewing and printing. |
|
|
Site-PI does not sign-off or certify; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
6 |
If Site-PI declines in step 5, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the Site-PI requested through his/her workflow queue with a note back to the Site-PI or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 5 until Site-PI has signed-off.
Status = Submitted |
7 |
If Site-PI accepts in step 5 and NWH, NSMC, or SRH is included in the study, then Site IRB Chair must complete sign-off. |
Site IRB Chair signs-off from their workflow queue and clicks ‘Accept’.
The sign-off form is not saved as a PDF document; however the action of signing off is saved in workflow. |
The status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited. E-mail notification is sent to the HRO intake person with a link to Insight indicating that the protocol has been submitted. A task is added to their workflow queue.
Status = Pending
|
|
|
Site IRB Chair does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight Activity List for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
8 |
If Site IRB Chair declines in step 7, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the Site IRB Chair requested through their workflow queue with a note back to the Site IRB Chair or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 7 until Site IRB Chair has signed-off.
Status = Submitted |
9 |
HRO Intake person pre-reviews the submission.
|
HRO Intake person clicks ‘Accept’. |
E-mail notification is sent to all non-critical Study staff with a link to Insight to sign-off.
For the HRO office, this is where workflow ends and current processes continue. Board assignment will happen in ReX.
Status = Pending |
|
|
HRO Intake person clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Pending |
10 |
If HRO Intake person declines in step 9, then the Submitter must take action. The Submitter can either ‘Decline’ the changes the HRO Intake person requested through their workflow queue with a note back to HRO Intake person or the Submitter can make the necessary changes to the protocol and resubmit. The act of resubmission will clear the task from the submitter’s queue. |
|
Workflow loops back to Step 9 until HRO Intake person accepts.
Status = Pending |
11 |
Once HRO Intake person accepts in step 9, then non-critical study staff can complete sign-off.
* This step is not certification. This is just the Study staff acknowledging that they will or will not participate on the study. Only if they accept, then they will be given a task to certify.
|
Non-critical study staff members complete sign-off that they will be part of the study in their workflow queue and click ‘Accept’. |
E-mail notification is sent to non-critical study staff to certify.
Status = Pending |
|
|
Non-critical study staff members do not sign-off that they will be part of the study in their workflow queue and click ‘Decline’ with comments on why declining. |
No action at this time. *Members can be removed once the board reviews the application and unlocks it with ReqMod status.
Status = Pending |
12 |
If non-critical study staff members accept in step 11, then non-critical study staff must complete certification.
|
One or more non-critical study staff members complete the certification form in their workflow queue and click ‘Accept’. |
The certification form will be attached to the study staff on the Staff & Access page as a PDF. |
|
Non-critical study staff members do not complete certification.
|
One or more non-critical study staff members complete the certification form in their workflow queue and click ‘Decline’ with comments on why declining. |
No action at this time.
*Members can be removed once the board reviews the application and unlocks it with ReqMod status.
Status = Pending |
Step # |
Step |
Workflow Action |
Results |
1 |
Submitter initiates an Amendment and completes the questionnaire. |
None |
Application is saved in Insight and can be viewed and accessed from the Work In Progress page.
Status = In Progress |
2 |
Submitter has completed, successfully validated and submitted the application. |
None |
1- E-mail notification is sent to the Protocol Administrator assigned to the particular protocol with a link to Insight for determining review type and routing to the correct HRO board administrator. 2- E-mail notification is sent to PI with a link to Insight for Electronic signature.
Status = Submitted |
3 |
PI sign-off |
PI signs-off from his/her workflow queue and clicks ‘Accept’. |
Status = Pending
|
|
|
PI does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Protocol is automatically unlocked for the PI to make changes.
Status = Submitted |
4a |
Protocol Administrator reviews protocol and makes determination. In this scenario determination is that the protocol “Needs Correction”. |
Protocol Administrator clicks “Needs Correction” and routes the protocol back to the Submitter with comments on corrections needed. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Protocol is automatically unlocked for the Submitter to make changes.
Status = Pending |
5a |
If action in step #4 is “Needs Correction”, then Submitter makes any necessary changes and saves application. |
None |
E-mail notification is sent to the Protocol Administrator with a link to Insight for determining review type and routing to the correct HRO board administrator. (Next step is 4a or 4b)
Status = Pending |
4b |
Protocol Administrator reviews protocol and makes determination. In this scenario determination is that the protocol is complete. |
Protocol Administrator clicks ‘Accept’. |
NOTE: For the HRO office, this is where workflow ends and current processes continue. Assignment to board will happen in ReX.
Status = Pending |
8 |
If the Amendment involves changes to Drugs/Nursing/Device/Radiation questionnaires, then the application will be routed to ancillary review. - If Drugs/Biologics/Dietary Supplements or Ancillary Drugs is checked - If Nursing Implementation/ Planning is checked - If Medical Device or Ancillary Non-Hospital Device is checked - If Radiation (Ionizing) or Radiation (Non-Ionizing) is checked |
None |
E-mail notification is sent to the point person for each Ancillary board with a link to Insight indicating that the protocol requires an Ancillary review.
Status = Pending |
9 |
|
Ancillary Admin acknowledges the new protocol in queue and clicks ‘Accept’
|
E-mail notification is sent back to the HRO Intake person that the protocol as been Accepted.
For Ancillary review, this is where workflow ends and current processes continue.
Status = Pending |
|
|
Ancillary Admin acknowledges the new protocol in queue and clicks ‘Decline’
|
E-mail notification is sent back to the HRO Intake person that the protocol as been Declined.
For Ancillary review, this is where workflow ends and current processes continue.
Status = Pending |
Workflow Steps – Continuing Reviews
Step # |
Step |
Workflow Action |
Results |
1 |
Submitter initiates a Continuing Review and completes the questionnaire |
None |
Application is saved in Insight and can be viewed and accessed from the Work In Progress page.
Status = In Progress |
2 |
Submitter has completed, successfully validated and submitted the CR application |
None |
1- E-mail notification is sent to the HRO CR Intake person with a link to Insight for determining review type and routing to the correct HRO board administrator. 2- E-mail notification is sent to PI with a link to Insight for electronic signature.
Status = Submitted |
3 |
PI sign-off |
PI signs-off from his/her workflow queue and clicks ‘Accept’. |
Status = Pending
|
|
|
PI does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Status = Submitted |
4a |
HRO CR Intake person reviews protocol and makes determination that the application is incomplete. |
HRO CR Intake person clicks “Decline” and routes the protocol back to the Submitter with comments on corrections needed. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Protocol is automatically unlocked for the Submitter to make changes.
Status = Pending |
5a |
If action in step #3 is “Decline”, then Submitter makes any necessary changes and saves application. |
None |
E-mail notification is sent to the HRO Intake person with a link to Insight for determining review type and routing to the correct HRO board administrator. (Next step is 4a or 4b)
Status = Pending |
4b |
HRO CR Intake person reviews protocol and makes determination. In this scenario determination is that the protocol is complete. |
HRO CR Intake person clicks ‘Accept’. |
NOTE: For the HRO office, this is where workflow ends and current processes continue. Assignment to board will happen in ReX
Status = Pending |
Workflow Steps – Adverse Events and Other Events
Step # |
Step |
Workflow Action |
Results |
1 |
Submitter initiates an Adverse Event or Other Event and completes the questionnaire. |
None |
Application is saved in Insight and can be viewed and accessed from the Work In Progress page.
Status = In Progress |
2 |
Submitter has completed, successfully validated and submitted the application. |
None |
1- E-mail notification is sent to the Protocol Administrator assigned to the particular protocol with a link to Insight for determining review type and routing to the correct HRO board administrator. 2- E-mail notification is sent to PI with a link to Insight for electronic signature.
Status = Submitted |
3 |
PI sign-off |
PI signs-off from his/her workflow queue and clicks ‘Accept’. |
Status = Pending
|
|
|
PI does not sign-off; and clicks ‘Decline’ with comments on why declining. |
E-mail notification is sent to the submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Protocol is automatically unlocked for the PI to make changes.
Status = Submitted |
4a |
HRO CR Intake person reviews protocol and makes determination that the application is incomplete. |
HRO CR Intake person clicks “Decline” and routes the protocol back to the Submitter with comments on corrections needed. |
E-mail notification is sent to the Submitter with a link to Insight for review.
All contact people also receive e-mail notification, but will not see an entry in their Activity List.
Protocol is automatically unlocked for the Submitter to make changes.
Status = Pending |
5a |
If action in step #4 is “Decline”, then Submitter makes any necessary changes and saves application. |
None |
E-mail notification is sent to the Protocol Administrator with a link to Insight for determining review type and routing to the correct HRO board administrator. (Next step is 4a or 4b)
Status = Pending |
4b |
Protocol Administrator reviews protocol and makes determination. In this scenario determination is that the protocol is complete. |
Protocol Administrator clicks ‘Accept’. |
For the HRO office, this is where workflow ends and current processes continue. Assignment to board will happen in ReX.
Status = Pending |
The data on the Staff & Access page can be added, removed or modified at different stages of the protocol application and submission process. Because of the transactional nature of the page, security rules are enforced according to what state the protocol is in and what type of access a user has been granted. If a staff member is removed from a study, they will no longer have access to the protocol. Below are the security rules:
For new protocol submissions that are created in Insight via the eIRB process:
Upon selecting a role of ‘Principal Investigator’ or ‘Site Responsible Investigator’, the Contact Person box is checked and Manage Permission access is assigned. These default settings cannot be changed.
Anyone with Edit or Manage access to the protocol can add, remove or edit study staff before the HRO ‘Accepts’ the submission. Once the HRO accepts, only the Permission and Contact Person columns can be edited. To make other changes to the study staff, the user must wait until the submission is reviewed and the overall status changes to ‘Req Mod’ (requires modification). If the status does not change to ‘Req Mod’ but to ‘Approved’, then an Amendment is required to add or remove study staff.
Anyone with Manage access has the ability to modify permissions (user access levels) before the HRO ‘Accepts’.
Anyone with Edit or Manage access to the protocol can add non-study staff (default permission is ‘view’). Non-study staff names and access can be added, edited or removed at any time.
All users with View access to the protocol can access the Staff & Access page in order to view the study staff and non-study staff associated with the protocol.
If a user does not have a username, the user will not have access to the system and therefore the permission level will be blank.
For protocols that were created prior to the electronic submission process (a paper application was submitted and the protocol was manually entered into Research Express):
Principal Investigator, Site Responsible Investigator and any study staff designated as a contact person are assigned Manage access.
All other study staff members not designated as a contact person are assigned Edit access.
Study staff not assigned a role in Research Express (ReX) are assigned View access.
Any person designated as a contact person only (and not study staff) are designated as non-study staff and assigned View access.