ARCHIVE Data and safety monitoring
Section 5
Monitoring for Serious Adverse Events – ARCHIVED
In some ePCTs, serious adverse events (SAEs) such as death may be an expected outcome (eg, suicide prevention trials [Sisti et al 2018] or studies with very ill populations). As in a traditional RCT with such a population, monitoring of individual SAEs is not likely to be helpful; however, monitoring comparative rates of SAEs between treatment arms can help to ensure that the study intervention is not causing more SAEs.
SECTIONS
CHAPTER SECTIONS
sections
- Introduction – Data and Safety Monitoring ARCHIVED
- Which PCTs Should Have a DMC? – ARCHIVED
- Monitoring Protocol Adherence – ARCHIVED
- Data Issues With Monitoring PCTs – ARCHIVED
- Monitoring for Serious Adverse Events – ARCHIVED
- Futility Assessment V. 2 – ARCHIVED
- Futility Assessment – ARCHIVED
- Case Study: Planning for Monitoring PCTs – ARCHIVED
- Including Stakeholder Perspectives – ARCHIVED
- Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
- Additional Resources – ARCHIVED
REFERENCES
Sisti DA, Joffe S. 2018. Implications of zero suicide for suicide prevention research. JAMA. 320:1633–1634. doi:10.1001/jama.2018.13083.
current section : Monitoring for Serious Adverse Events – ARCHIVED
- Introduction – Data and Safety Monitoring ARCHIVED
- Which PCTs Should Have a DMC? – ARCHIVED
- Monitoring Protocol Adherence – ARCHIVED
- Data Issues With Monitoring PCTs – ARCHIVED
- Monitoring for Serious Adverse Events – ARCHIVED
- Futility Assessment V. 2 – ARCHIVED
- Futility Assessment – ARCHIVED
- Case Study: Planning for Monitoring PCTs – ARCHIVED
- Including Stakeholder Perspectives – ARCHIVED
- Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
- Additional Resources – ARCHIVED