The following are examples of amendments that the Amend Trial feature accommodates.
- Dose Escalation Amendment (change in the number of patients treated at a given dose level)
- Change in Sites Open to Patient Accrual
- Change in Principal Investigators
- Change in Risk to Participants (new risk identified [new CAEPR], changes made as a result of an updated Severe Adverse Event)
- Scientific Change (opening an arm, adding a new arm, closing an arm, changing objectives, changing statistical analysis, adding correlative studies, increase or decrease in the accrual goal, changing from Phase I to Phase II, additional data points)
- Correction of Typographical Errors which Change Scientific Meaning (mg vs. mcg)
- Eligibility Change (change to the inclusion or exclusion criteria)
- Therapy Change (change in dose, adding another agent, change in administration, change in route)
To open the trial record for amending, refer to Amending Trials.
