Workflow Steps - New Standard, New TISSUE, and Triennial Review

 

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’.

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

 

 

 

The status of the protocol switches to ‘Pending’ and the protocol is locked and cannot be edited.  E-mail notification is sent to the SRAC inbox with a link to Insight indicating that the protocol has been submitted.  A task is added to workflow queue.

6

SRAC Intake person checks the submission.

 

 

SRAC Intake person clicks ‘Accept’.

Based on answers to forms questions, routing to Ancillary review boards (Safety, Biosafety, Radiation, NIH, Tissue) 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 the SRAC pre-review person with a link to Insight for review. A task is added to workflow queue.

 

Status = Pending

 

 

SRAC Intake person clicks ‘Decline’ with comments on why declining.

E-mail notification is sent to the submitter with a link to Insight for review.

 

Status = Pending

7

SRAC pre-review person reviews the submission.

 

 

SRAC pre-review person clicks ‘Accept’.

E-mail notification is sent to all study staff with a link to Insight to sign-off. (See step 9).

 

For the SRAC office, this is where workflow ends and current processes continue.  Assignment to board will happen in ReX.

 

Status = Pending

 

 

SRAC pre-review 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

8

If SRAC pre-review person declines in step 6, then the Submitter must take action.  The Submitter can either ‘Decline’ the changes the pre-review person requested through their workflow queue with a note back to pre-review 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 7 until SRAC pre-review person accepts.

 

Status = Pending

9

Once SRAC pre-review person accepts in Step 7, then 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.

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 study staff to certify.

 

Status = Pending

 

 

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

10

If study staff members accept in step 9, then study staff must complete certification.

 

One or more 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

 

Study staff members do not complete certification.

 

 

One or more 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.

11

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 SRAC inbox that the protocol has been Accepted.

 

NOTE:

For Ancillary review, this is where workflow ends and current processes continue.

Reviewer will notify the SRAC via e-mail or fax of the outcome of the review.  The board action and notes will be entered manually into Rex.

 

Status = Pending

 

 

Ancillary Board point person acknowledges the protocol in queue and clicks ‘Decline’

 

E-mail notification is sent back to the SRAC Inbox person that the protocol as been Declined.

 

For Ancillary review, this is where workflow ends and current processes continue.

 

Status = Pending