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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

  1. Drug Development Process
  2. Device Development Process
  3. Investigational New Drug (IND)
  4. Study Design
  5. Responsibilities of the Research Team

Study Start-Up Activities

  1. Finding Potential Sponsors and Studies
  2. Site Interest Letters and Questionnaires
  3. Confidential Disclosure Agreements
  4. Assessing Protocol Feasibility
  5. University Approvals / Institutional Requirements
  6. Research Billing Office

Finance and Contracts Pre-Award

  1. Research Study Budget Design & Analysis
  2. Clinical Trial Agreement
  3. Material Transfer Agreements

Regulatory & IRB

  1. Human Subjects Research Regulations
  2. Regulatory Documents
  3. Submission to the Institutional Review Board
  4. Data Safety Monitoring Plans (DSMP)

Subject Management & Site Activities

  1. Site Monitor Visits
  2. Drug Supply Management and Accountability
  3. Recruitment of Research Study Participants
  4. Informed Consent in Research
  5. Screening Practices
  6. Scheduling and Preparing for a Study Visit
  7. Participant Retention Planning
  8. Data Management (CRFs and Source)
  9. Adverse Events and Serious Adverse Event Management
  10. Study Implementation / In-Service Training

Finance and Contracts Post Award

  1. Award and Project Set-up
  2. Invoicing
  3. Processing Sponsor Payments
  4. Monitoring Accounts and Receivables
  5. Payments to Human Subject Participants

Quality Management

  1. Audits
  2. Quality Management Overview and Tools

Privacy Practices

  1. HIPAA and Research

Clinical Skills

  1. Clinical Skills

Electronic Applications

  1. 21 CFR 11
  2. Research Operations Web Application (ROWA)
  3. Integrated Health Information System (IHIS)

Standard Operating Procedures

  1. Writing Standard Operating Procedures (SOPs)

Researcher Resources

  1. 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  

 

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