From: Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality
Operational staff | Tasks delegateda |
---|---|
Operational trial statistician | Draft analysis plans; prepare Data Monitoring Committee reports; report to Data Monitoring Committee; conduct analyses |
Trial manager | Essential document version control; seek necessary approvals; manage the intervention supply to study sites; schedule study oversight meetings; monitor study site activity; process serious adverse event reports; ethics and regulatory reporting; present to Trial Management Group |
Data manager or software analyst | Design case report forms; programme electronic data capture systems; undertake system testing; data cleaning activities; reports and dataset preparation |
Study site monitors | Conduct source data verification; confirm site records are being maintained appropriately; training study site staff |
Study administrators | Assist with Trial Master File maintenance; manage daily communications |