Clinical Trial Checklist Instruction Page

Clinical Trial Checklist Instruction Page

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: .
  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

.

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.

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

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