Clinical Trial Checklist Instruction Page Principal Investigator

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Clinical Trial Checklist Instruction Page
Principal Investigator:
1. If you believe that your study does not meet the definition of a clinical trial, or does not occur
at an EHC facility, please contact Laura Deane at (404) 778-4301 or email:
laura.deane@emoryhealthcare.org.
2. Complete study related information on the Clinical Trial Checklist Signature Page and
indicate which EHC entities are involved in the Clinical Trial Study;
3. If Clinical Trial Study meets exemption criteria for any department, please sign and date
Exempt Criteria Attestation (Please see below for departmental exemption criteria).
4. If the Clinical Trial Study does not meet exemption criteria, please provide signature and date
as to when the Clinical Trial Study is ready to begin; Complete the non-exempt checklists; and
e-mail the signature page with completed checklists to
catherstine.jones@emoryhealthcare.org.
Exemption Criteria:
DEPARTMENT OF RADIOLOGY AND IMAGING SCIENCES

No imaging required per protocol

All imaging to be performed at BITC or CSI
LABORATORY SERVICES
No lab tests drawn or performed by EML
Investigational Drug Service

Protocol does not involve study drugs

Study drugs are not provided for the study
NURSING SERVICES

A study that involves care provided by the study’s research nurse only. No EHC nursing staff will be
involved in caring for the study’s patients.

Study that does not involve patients receiving care at an EHC facility.
Ver. 8-2013
Clinical Trials Checklist Signature Page
Principal Investigator: _____________________________ email______________________
Study Name: ____________________________________ IRB Number: _________________
Start Date: ________________ End Date: ______________
Study Coordinator: ________________ email__________________ Telephone#:___________
Patient Type(s): Inpatient
Outpatient
*EHC Facility or Facilities in which the Clinical Trial study takes place:
WCI EUH TEC EUHM EUOSH EJC ST. JOSEPH CLINIAL RESEARCH NETWORK
Attestation Statement:
Radiology (RAD): Exemption Criteria
 Based on review of Exemption Criteria, I attest that this trial is exempt from further review by Radiology.
Principal Investigator signature_________________ Date_________________
Laboratory (LAB): Exemption Criteria Attestation Statement:
 Based on review of Exemption Criteria, I attest that this trial is exempt from further review by Laboratory.
Principal Investigator signature_________________ Date_________________
Nursing (NUR): Exemption Criteria Attestation Statement:
 Based on review of Exemption Criteria, I attest that this trial is exempt from further review by Nursing.
Principal Investigator signature_________________ Date_________________
Investigational Drug Service (IDS):
 Based on review of Exemption Criteria, I attest that this trial is exempt from further review by IDS.
Principal Investigator signature_________________ Date_________________
Ver. 8-2013
Ver. 8-2013
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