Protocol Events-Welcome
Welcome to the course!
Protocol Events-Protocol Events
Types of Protocol Events
()
Roles and Responsibilities
()
Additional Resources
()
Regulatory Affairs and Trial Misconduct -Regulatory Affairs and Trial Misconduct
Ethical Oversight of Clinical Trials
()
Federal Ethical Regulations
()
Product-Approval Agencies
()
Trial Misconduct
()
Additional Resources
()
Standardization, Transparency, and Research Reproducibility-Standardization, Transparency, and Research Reproducibility
International Council for Harmonisation
()
CONSORT
()
SPIRIT and Trial Registration
()
Additional Resources
()
Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis-Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis
Systematic Reviews
()
Steps in the Systematic Review Process
()
Formulating Questions for Systematic Reviews
()
Searching for and Selecting Studies
()
Data Abstraction and Risk of Bias Assessment
()
Data Analysis and Synthesis
()
Study Documents-Study Documents
Overview
()
Types of Study Document
()
Regulatory Study Documents
()
Study Documents Related to Design and Implementation
()
Participant-Facing Study Documents
()
Data-Related Study Documents
()
Investigational Product
()
Laboratory Information
()
Monitoring
()
Staffing and Training
()
Close-Out
()
Other Documentation
()
Closing
()
Closing Thoughts