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 |
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’. |
E-mail notification is sent to the SRAC inbox with a link to Insight for determining review and routing to the correct administrator.
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 Clarification”. |
Protocol Administrator clicks “Needs Clarification” 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 Clarification”, 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 review. (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 SRAC office, this is where workflow ends and current processes continue. Assignment to board will happen in ReX.
Status = Pending |
|
5b |
If the Amendment involves changes to study staff or to a new PI, 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. |
|
6 |
If the Amendment involves changes to Biologics/ Chemicals/Biological/Radiation/Funding questionnaires, then the application will be routed to ancillary review. - If Biologics (tumor or ascites production) is checked (Tissue Testing) - If Chemicals/ Biological/ Radiation is checked (Biosafety, Safety, Radiation) - If Funding (NIH review) |
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 |
|
7 |
|
Ancillary point person acknowledges the protocol in queue and clicks ‘Accept’
|
E-mail notification is sent back to the SRAC Inbox that the protocol has been Accepted.
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 point person acknowledges the protocol in queue and clicks ‘Decline’
|
E-mail notification is sent back to the SRAC Inbox that the protocol as been Declined.
For Ancillary review, this is where workflow ends and current processes continue.
Status = Pending |
|