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Page Title
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Example Content Display: Option 1
- Sponsor agreements
- Principle investigator responsibilities
- Obtain study approvals
- Hire and train team
- Identify and secure resources
- Communications
- Protocol development
- Determination of study type
- Clinical Study
- Clinical Trial
- Applicable Clinical Trial (ACT)
- Investigator Initiated Trials (IITs)
- Industry Sponsored Trials
- Study design
- Study endpoints
- Authorized investigators and designees
- Consent guidelines
- HIPAA requirements
- Determination of study type
- IRB review
- Submit a Protocol
- Training videos
- Registration of Trial on clinicaltrials.gov
- Recruitment tool planning (IRB oversight, compliance, research integrity)
- Investigator Brochures (IB)
- Research team staffing and training
- Patient documentation
- Informed consents
- Consent process
- Case Report Forms (CRFs)
- Informed consents
- Good Clinical Practices (GCP)
- Standard Operating Procedures
- Training videos
- NIH SOP toolbox
- Data collection and integrity
- Data analysis and statistical considerations
- Trial adverse events
- Monitoring and site audits
- Closeout procedures
Example Content Display: Option 2
Study Planning
- Sponsor agreements
- Principle investigator responsibilities
- Obtain study approvals
- Hire and train team
- Identify and secure resources
- Communications
- Protocol development
- Determination of study type
- Clinical Study
- Clinical Trial
- Applicable Clinical Trial (ACT)
- Investigator Initiated Trials (IITs)
- Industry Sponsored Trials
- Study design
- Study endpoints
- Authorized investigators and designees
- Consent guidelines
- HIPAA requirements
- Determination of study type
Study Execution
- IRB review
- Submit a Protocol
- Training videos
- Registration of Trial on clinicaltrials.gov
- Recruitment tool planning (IRB oversight, compliance, research integrity)
- Investigator Brochures (IB)
- Research team staffing and training
- Patient documentation
- Informed consents
- Consent process
- Case Report Forms (CRFs)
- Informed consents
- Good Clinical Practices (GCP)
- Standard Operating Procedures
- Training videos
- NIH SOP toolbox
- Data collection and integrity
- Data analysis and statistical considerations
- Trial adverse events
- Monitoring and site audits
- Closeout procedures