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Table 1 Delegation of trial tasks

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
  1. aNote: tasks may be allocated to different roles or disciplines, depending on available staff