| 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. |
| 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. |
Office of Regulatory Affairs and Research Compliance
