Obligations for monitoring of safety and trial conduct may affect routine clinical practice care. Read more on RBM and timely capture of data on serious adverse events.
A series of eight papers has been published in the Journal of Clinical Epidemiology.
Introduction: Pragmatic trials and Real World Evidence
Selection and inclusion of usual care sites
Participant eligibility, recruitment and retention
Challenges of informed consent
Questions, comparators and treatment strategies
Outcome selection and measurement
Monitoring safety and trial conduct
Read more on monitoring safety and trial conduct in our JCE paper series, which discusses the pragmatic design choices related to safety and quality.
For a summary, please click here.
Go back to resources page