Table 2 Frequency of review
Data type | Frequency of review | ||
|---|---|---|---|
Each occurrence | Quarterly | Annually | |
Self-reported adverse events | X | ||
Serious adverse event meeting prompt reporting criteria | X | ||
Summary of serious adverse events | X | ||
Protocol violations/noncompliance | X | ||
Summary of adverse events | X | ||
Subject accrual/randomization | X | ||
Withdrawal rates | X | ||
Subject complaints | X | ||
Compliance to interventions | X | ||
Out of range data | X | ||
Reassessment of risk-to-benefit | X | ||