Clinical Research Coordinator Resources
Education and training resources for clinical research coordinators and staff
This educational resource is for Clinical Research Coordinators, both new and experienced, and other clinical research staff at The Ohio State University who are seeking training resources from around the University, including written material, classes and computer based learning modules. Also see the related documents and templates at the bottom of this page.
The material offered here follows the “life of a clinical trial” so that users may quickly jump to their particular area(s) of interest.
NCH Clinical Research Services
General Research Principles
- Drug Development Process
- Device Development Process
- Investigational New Drug (IND)
- Study Design
- Responsibilities of the Research Team
Study Start-Up Activities
- Finding Potential Sponsors and Studies
- Site Interest Letters and Questionnaires
- Confidential Disclosure Agreements
- Assessing Protocol Feasibility
- University Approvals / Institutional Requirements
- Research Billing Office
Finance and Contracts Pre-Award
Regulatory & IRB
- Human Subjects Research Regulations
- Regulatory Documents
- Submission to the Institutional Review Board
- Data Safety Monitoring Plans (DSMP)
Subject Management & Site Activities
- Site Monitor Visits
- Drug Supply Management and Accountability
- Recruitment of Research Study Participants
- Informed Consent in Research
- Screening Practices
- Scheduling and Preparing for a Study Visit
- Participant Retention Planning
- Data Management (CRFs and Source)
- Adverse Events and Serious Adverse Event Management
- Study Implementation / In-Service Training
Finance and Contracts Post Award
- Award and Project Set-up
- Invoicing
- Processing Sponsor Payments
- Monitoring Accounts and Receivables
- Payments to Human Subject Participants
Quality Management
Privacy Practices
Clinical Skills
Electronic Applications
Standard Operating Procedures
Researcher Resources
Related documents and templates
| Site Interest Letters and Surveys | IRB Documents |
| Site Selection Letter | DSMB Charter Template |
| Site Set-Up Letter | Informed Consent Templates |
| Study Rejection Letter | Informed Consent in Research |
| Researcher Resources | Standard Operating Procedures |
| CCTS Researcher Resources Powerpoint Presentation |
Standard Operating Procedures |
| Regulatory Documents | |
| Eligibility Checklist | Protocol Training Log |
| Enrollment Log | Screening Log |
| Monitor Visit Log | Subject Code Log |
| Feasibility Checklist | Violation Tracking Log |
| Note to File |