Full curriculum across all programs

1. 01Introduction to Clinical Research
2. 02Clinical Trial Phases
3. 03Roles of Sponsor, CRO, Site, PI, CRA, and CRC
4. 04Good Clinical Practice Overview
5. 05Protocol Basics
6. 06Informed Consent
7. 07Source Documentation
8. 08Regulatory Binder and Essential Documents
9. 09Clinical Trial Data and EDC
10. 10Safety Reporting Basics

1. 01Role of the Clinical Study Coordinator
2. 02Study Startup and Site Activation
3. 03Patient Recruitment and Screening
4. 04Informed Consent Workflow
5. 05Visit Preparation
6. 06Subject Visit Execution
7. 07Source Documentation
8. 08EDC Entry and Query Resolution
9. 09Labs, Vitals, EKGs, and Assessments
10. 10Adverse Event Documentation
11. 11Protocol Deviations
12. 12Monitoring Visit Preparation
13. 13Regulatory Binder Maintenance
14. 14Close-Out Visit Preparation
15. 15Final CRC Assessment

1. 01Role of the Clinical Research Associate
2. 02Sponsor/CRO/Site Relationship
3. 03Study Startup Review
4. 04Site Qualification Visit
5. 05Site Initiation Visit
6. 06Interim Monitoring Visit
7. 07Remote Monitoring
8. 08Risk-Based Monitoring
9. 09Source Data Verification
10. 10Informed Consent Review
11. 11Drug Accountability
12. 12Protocol Deviation Review
13. 13Safety Review
14. 14Essential Document Review
15. 15Monitoring Visit Follow-Up Letters
16. 16Monitoring Visit Report Basics
17. 17Site Close-Out Visit
18. 18CRA Interview Preparation
19. 19Final CRA Assessment

Template Vault (17 downloads)