| Study Startup Checklist | For study teams to ensure they have everything necessary in place before starting the study once approved by the IRB | July 2024 |
| Regulatory Binder Guidance | Guidance and suggested structure of all study and regulatory related documents | July 2024 |
| Delegation of Authority Log | For PIs document the roles and responsibilities of study team members | July 2024 |
| Training Log | Records any training, such as protocol training or other study-specific training that is provided to study team members but not otherwise documents by a training completion certificate | July 2024 |
| Participant Eligibility Checklist | Documents eligibility and ensures that participants meet inclusion criteria requirements | July 2024 |
| Screening/Enrollment Log | Records the status of potential participants in a research study, including who was screened for eligibility and who was enrolled | July 2024 |
| Subject Visit Tracking Log | Contains all study participants, their relevant study information, as well as tracking information about their completion of project milestones | July 2024 |
