Approval Required Before Irb-Approved Consent Released

Clinical Research Readiness Checklist

**APPROVAL REQUIRED BEFORE IRB-APPROVED CONSENT RELEASED**

INSTRUCTIONS: Obtain approval signatures for each applicable category below—can complete in any order. Insert additional rows if needed. If not applicable to your research protocol, write N/A in the signature column. Fax this “Clinical Research Readiness Checklist” with all the required signatures to Laura Deane in the Office of Quality & Risk at (404) 712-7941 or scan & email to .

IRB #: Study Title:

Principal Investigator (PI): Clinical Research Coordinator (CRC):

Research Team Protocol Orders/Education / Print/Type Name / Signature / Date
1)  Research Team Process:
·  Protocol training provided to research team including MD investigators, nurses & coordinators
·  Protocol orders written & signed by PI / PI:
/ PI:
CRC: / CRC:
Clinical Team Protocol Orders/Education
2)  EHC Feasibility Approval:
·  IS/CPOE consulted for protocol orders
·  Orders reconciled with study & care delivery team
·  Orders delivered to applicable care areas / IS/CPOE Approval (if applicable): / IS/CPOE Approval (if applicable):
EHC Nurse Clinical Leader: / EHC Nurse Clinical Leader:
3)  In-service completed for clinical unit per protocol:
·  Occurs after all orders are signed off / EHC Nurse Clinical Leader: / EHC Nurse Clinical Leader:
4)  In-service completed for all applicable ancillary stakeholders per protocol:
·  Occurs after all orders are signed off
·  Lab signature denotes review & approval of Lab Checklist
·  Radiology signature denotes review & approval of Radiology Checklist / *Lab: / *Lab:
*Radiology: / *Radiology:
Other Applicable Ancillary Departments
(e.g. Respiratory Therapy, Physical Therapy, etc.): / Other Applicable Ancillary Departments
(e.g. Respiratory Therapy, Physical Therapy, etc.):
Investigational Drug Service Approval
5)  Study has fulfilled IDS requirements:
·  Preprinted orders created by IDS
·  IDS Drug Data Sheet completed and sent to OCR / IDS Pharmacist: / IDS Pharmacist:
Internal Use Only / Initial
EHC Clinical Facility Approval of Study Site Feasibility
(signature indicates consent can be released by IRB) / EHC Executive: / EHC Executive:

NOTE: Upon request, the IRB may release an IRB stamped consent if needed for Site Initiation Visit.

*Attach Lab & Radiology Checklists, if applicable Revision Date: February 20, 2012