1. Clinical Trial Site Members
1.1. Clinical Assistants
1.1.1. Trial Issues
1.1.2. Status Updates
1.1.3. Trial information/progress
1.2. Investigator
1.2.1. Identify/Select
1.2.1.1. Clinical Site Members
1.2.1.2. Trial site
1.2.1.2.1. Closing trial site when trial complete
1.2.2. Oversee conduct of trial
1.2.2.1. Writing/Filing/Documenting
1.2.2.1.1. Visit reports
1.2.2.1.2. Trial documentation
1.2.2.1.3. Trial reports
1.2.2.1.4. Follow up visit reports
1.2.3. Monitor activities
1.2.3.1. Compliance with protocol
1.2.3.2. Compliance with regulatory requirements
1.2.3.3. Assist with audits/inspections
1.2.3.4. Standard Operating Procedures
1.2.3.5. Good Clinical Practice
1.2.3.6. Ensure departmental training
1.3. Clinical Site Staff
1.3.1. Technicians/Statisticians
1.3.1.1. Ensuring Source Data Verification
1.3.1.2. Discuss results
1.3.1.2.1. Technical trial reports
1.3.2. Doctors/Staff Nurses
1.3.2.1. Ensure proper training
1.3.2.2. Use of proper tools
1.3.2.3. Use of proper materials
1.3.2.3.1. Unused materials accounted for
2. Clinical Research Associates
2.1. Keep Knowledge updated
2.1.1. Symposiums
2.1.2. Conferences
2.1.3. Continuing education training
2.2. Updates
2.2.1. Trial Issues
2.2.2. Trial Progress
3. Sponsor/Contract Research Organization
3.1. Pharmaceutical Company
3.1.1. Contract Research Orgranizations
3.1.1.1. Develop/Write
3.1.1.1.1. trial protocols
3.1.1.1.2. Case Report Forms
3.1.1.2. Manage
3.1.1.2.1. Regulatory Authority Applications
3.1.1.2.2. Trial Budget/Finances
3.1.1.3. Plan/Organize/Conduct
3.1.1.3.1. Research topic
3.1.1.3.2. Trial progress
3.1.1.3.3. Trial results
3.1.1.4. Oversee/monitor
3.1.1.4.1. Good Clinical Practice
3.1.1.4.2. Standard Operating Procedures
3.1.1.4.3. Adherence to research protocol
3.1.2. Archiving correspondance
3.1.2.1. Liaison between sponsor and site members
3.2. Clinical Vendors
3.2.1. Data Management Teams
3.2.2. Central Laboratories
3.2.3. Biostatistics
4. Participants
4.1. Rights
4.1.1. Informed Consent