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HSP Module 6: Monitoring Research Data, Auditing Protocols and Reporting Adverse Events
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HSP Module 6: Monitoring Research Data, Auditing Protocols and Reporting Adverse Events
Overview
Principles
General Guidance - Protocol Design
Protocol Design - Provisions for Data and Safety Monitoring
Protocol Design - Responsibility for Data and Safety Monitoring
Protocol Design - Establishing Criteria for Terminating or Re-Examining a Protocol
General Guidance - Conducting the Study
Conducting the Study - Identifying and Reporting Adverse and Unexpected Events - Social-Behavioral Research
Conducting the Study - Identifying and Reporting Adverse and Unexpected Events - Biomedical Research
Conducting the Study - Renewal of Approval for Protocols, Monitoring, and Postapproval Auditing of Research Protocols
Conducting the Study - Terminating a Study Because of Safety Concerns, Demonstrated Effectiveness of Intervention, or Futility of Continuing
General Guidance - Post-Study
Specific Guidance on Special Issues
Data and Safety Monitoring Committees
Audits and Data Monitoring by Federal Agencies
Regulations
Resources
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