Topics Map > OnCore
OnCore: Treatment
Data Field Definitions - click to expand/collapse a list of fields and requirements for entry
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|---|---|---|
| Select Arm | Click the “Add” button on the right to select the applicable arm from the drop down menu. Note: The arms populate from the PC Console > Treatment Tab. If there is more than one arm involved in the study, enter each one separately with the information below as they occur. |
Not Required
Populated from the PC Console > Treatment. |
No |
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|---|---|---|
| On Arm Date | The date a subject is registered or randomized to the first (or only) arm or the first day of a subsequent arm. If entered, an Off Arm Date must also be entered. This field is required for studies that involve crossover or subsequent arms for subjects. |
Not Required | No |
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|---|---|---|
| On Treatment Date | The date of the first dose of drug, procedure, or research event. If entered, an Off Treatment Date must be entered. |
Required in the situation(s) described
This field is required for studies that use an agent/or device. |
No |
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|---|---|---|
| Off Arm Date | The last date of the last arm (or end of “active protocol”), or the “On Arm” date of the subsequent arm. If entered, an On Arm Date must also be entered. |
Required in the situation(s) described
This field is required for studies that involve crossover or subsequent arms for subjects. |
No |