From screening of first participant through completion of last participant last visit (LPLV)
During the conduct stage, investigators agree to follow all applicable Clinical/Translational Research SOPs and JHM IRB policies and guidelines.
During this stage the following departments may be engaged:
- Initial Consent Conference Note
- Re-Consent Conference Note
- Age of Majority Consent Conference Note
- Withdrawal of Consent Conference Note
- Protocol Training Agenda
- Participant Eligibility Checklist
- AE Log
- Protocol Deviation Log
- Lost to Follow Up Letter
These tools are also commonly used during the conduct phase of the clinical research lifecycle:
- CHKL Informed Consent Verification
- CHKL Documenting Withdrawal of Consent
- WI Accessing Current ICF Version
- WI Utilizing Translators
- WI CTEP Investigator Registration
- WI Amending Eligiblity Checklist
- WI Creating Eligiblity Checklist
- WI Using Eligiblity Checklist
- EX Study-Specific Master Eligibility Checklist
- GUID Safety Event Reporting
- GUID Safety Event Reporting IND IDE Holder
- CHKL Change in PI
- GUID Creating Note to File
- CHKL Site Transfer Participants
Step 5: Oversight
Xổ số DanongInternal and external review of research conduct
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