Tools Instructions
Data and Safety Monitoring checklist Use this checklist to develop a comprehensive Data and Safety Monitoring plan.
External Inspection Prep checklist Use this checklist to prepare for an external audit/inspection to be conducted at a study site (e.g. for-cause or not for-cause audit by QIP, the sponsor, or any federal agency). Completion of this log demonstrates compliance with Good Clinical Practice (GCP) Guidelines, sections 4.1.1.
Informed Consent/Assent checklist Use this checklist to ensure that informed consent has been appropriately obtained and documented.
International Research Study Start-up checklist Use this checklist when developing recruitment strategies and implementing study start-up procedures for engaging research participants in an international setting.
Reliance Agreement checklist Use this checklist for multisite research to determine whether or not a reliance/cede review (where by one institution relies on another for IRB review and oversight) agreement is appropriate.
Specimen and Data Sharing Checklist Use this checklist when establishing a new research repository.