SiteMinder Only Submission

A department may choose to use SiteMinder for management of all of its clinical trials, including those without any clinical billable activities.  When submitting trials without clinical billable activities for development in SiteMinder, use of the SiteMinder Only submission category is appropriate.  SiteMinder Only submissions are forwarded directly to a SiteMinder Specialist, who manages CBR activity.

1.  Email submission to  Submission must include:

     a.  Completed CBR Submission Form

     b.  Study protocol, or UAB IRB Human Subjects Protocol (HSP) if a protocol is not available

     c.  Departmental bill-to-designation (see marked protocol schema example orexcel format)

2.  CBR checks submission for completeness, logs in study material upon receipt, assigns an internal FAP number, and forwards to a SiteMinder Specialist.  Electronic submissions are preferred, but hard copy submissions to CBR are accepted at the OSP located in the Administration Building, Room 1170.

3.  After the CBR reviews the submission for completeness, an acknowledgement email will be forwarded to:

     a.  department contact noted on the CBR Submission Form, and

     b.  others as needed.

     c.  Should submission be deemed incomplete, department submitter will be sent an email relaying what is outstanding for the submission.

NOTE:  Development in SiteMinder cannot begin until all necessary study documents are received, making the department’s submission complete.

4.  SiteMinder Specialist may direct queries to department submitters for resolution as part of the development process.  It is important that the department works with the SiteMinder Specialist to resolve queries before SiteMinder entry is initiated.

5.  SiteMinder Specialist initiates build of study record, site placement record, and budget/visit records in SiteMinder.

6.  SiteMinder Specialist emails department submitter a notification that the SiteMinder build is ready for department review and data entry.

7.  SiteMinder Specialist updates SiteMinder study status to “Under Negotiation”, indicating responsibility for next action resides with the department.

8.  Department reviews SiteMinder budget build (including visit names) and study activity list, and enters departmental data (1’s where appropriate) into SiteMinder budget spreadsheet (on charge tab).

9.  Department performs a check of all activities and data entry by generating a UABHS report entitled “Research Visit Outline” selected from the SiteMinder desktop.

10. Department is responsible for notifying the SiteMinder Specialist via email that the SiteMinder study budget is acceptable and ready to be finalized.

11. Should the department identify a need for revision, they should email the request to the SiteMinder Specialist assigned to the project.

12. At periodic intervals, CBR staff will email queries to the department to determine the status of SiteMinder studies not yet finalized.

13. The SiteMinder Specialist conducts a review of the proposed final SiteMinder budget and finalizes in the system.

14. The SiteMinder Specialist emails notification to the department designee that the SiteMinder budget is finalized and ready for use in managing the study.