Amendment Review Submission

 

Protocol amendments should be submitted for FAP review only if

  • protocol-driven clinical billable activities are affected (additions, deletions, changes in location of activities, etc.), or
  • changes to the SiteMinder budget are indicated (e.g., additional visits added).

1.  Email submission to This email address is being protected from spambots. You need JavaScript enabled to view it. .  Submission must include:

     a.  Completed CBR Submission Form

     b.  Amended study protocol along with list of specific revisions included in the amendment (or completed UAB IRB Project Revision/Amendment Form if revision list is not available).

     c.  Amended draft consent form(s)

     d.  Departmental bill-to-designation (see marked protocol schema exampleorexcel format) updated for amendment requirements.

     e.  If applicable, the following completed forms must be submitted:

                           i.         Radiology Research Quote Request form, and/or

                          ii.         UAB Hospital Flow Cytometry Lab form

     f.  If applicable due to amendment changes and when available, submit the following:

                           i.         amended sponsor budget or relevant modified grant/contract budget information, and/or

                          ii.         copy of amended Clinical Research Unit (CRU) award letter

 NOTE:     If research activities are being provided by an Ancillary Research Area that bills for their services internally, department to department (and therefore no billing is occurring through a UAB Health System entity), submission of amendment material to the Ancillary Research Area concurrent with FAP submission is encouraged.  For example, if using Tissue Procurement, Dermatology research, or Ophthalmology research services, departments should submit separately to those areas.

 

2.  CBR checks submission for completeness, logs in study material upon receipt, assigns an internal FAP number, and forwards to a FAP Analyst for review.  Electronic submissions are preferred This email address is being protected from spambots. You need JavaScript enabled to view it. , 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:     FAP review cannot begin until all necessary study documents are received, making the department submission complete.

 

4.  Amendment Review – Phase I

     a.  As applicable, repeat step 4 of Full FAP Review – Phase I.

 

5.  Amendment Review – Phase II

     a.  As applicable, repeat step 5 of Full FAP Review – Phase II.

     b.  If revision of a finalized, active SiteMinder budget is required, updating of SiteMinder will be completed by a SiteMinder Specialist.