Conduct Stage
From screening of first participant through completion of last participant last visit (LPLV)
ConductDuring the conduct stage, investigators agree to follow all applicable Clinical/Translational Research SOPs and IRB policies and guidelines.
During this stage the following departments may be engaged:
- Research Operations
- Clinical Research Unit (CRU)
- Investigational Drug Services (IDS)
- Biorepository
- Research & Grants Administration
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- Informed Consent Discussion & Documentation
- Participant Eligibility
- Adverse Event Review, Documentation, & Reporting
- Protocol Deviations
- Lost to Follow Up Participants
- Investigational Drug Services
- Procurement & Storage of Study Drug
- Dispensing of Study Drug
- Transfer of Study Drug
- Destruction or Return of Study Drug
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- 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
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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 Eligibility Checklist
- WI Creating Eligibility Checklist
- WI Using Eligibility 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
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Phase 3: Activation
From receipt of protocol approval(s) through initiation of participant screening
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Phase 5: Oversight
Internal and external review of research conduct