Conduct

• 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

• 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