Step
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Step | The Step(s) in the protocol are identified by a Step Code (1, 2, 3, etc.) and must be indicated as either Registration or Randomization. Once a Step is added to the protocol, Arms for that Step can be created by selecting the Arms hyperlink associated with the Step. |
Required Typically most protocols contain only Step Code 1. |
PC Console edit / Protocol Coordinator | Yes |