This section contains detailed information on each of the data elements included in the Batch Upload file.
Use of CDUS Values
Although you can use CDUS values, they are being phased out in the CTRP. It is best, therefore, to use the CTRP values listed in the table below.
When you create a batch file, ensure that each data element conforms to the requirements.
- List each data element in its appropriate position in a given row
- Use the correct character cases (CAPITAL vs. lower case letters)
- Use the correct character lengths (number of characters allowed in a single field)
If a comma is part of the value, enclose the field in double quotes. Otherwise the use of double quotes is optional.
Subject Accrual Data Elements Table with CTRP Accepted Values for Abbreviated Trials
Accrual Data Elements table with CTRP accepted values
| Accrual Data Element Name | Mandatory=M; Optional=O Conditional = C | Definition | CTRP Accepted Values | Information Model Class / Diagram Mapping |
|---|---|---|---|---|
| Study Identifier | M | Unique identifier assigned to the study | NCI, CTEP, or DCP Identifier | Study Protocol / assignedIdentfier |
| Study Site Identifier | M | Unique identifier (PO ID) assigned to the institution accruing the patient to the study | PO ID | Study Site / identifier |
| Study Site Accrual Count | M | Numeric count of subjects accrued at a study site to date | Numeric | Study Site / subjectAccrualcount |
| Cut-Off Date | O | The date from which the cumulative accrual count was calculated. | YYYYMMDD | (TBD) |
Subject Accrual Data Elements Table with CDUS Accepted Values for Abbreviated Trials
Accrual Data Elements table with CDUS-Accepted values
| Accrual Data Element Name | Mandatory=M; Optional=O Conditional = C | Definition | CDUS Accepted Values |
|---|---|---|---|
| Study Identifier | M | Unique identifier assigned to the study | CTEP Identifier |
| Study Site Identifier | M | Unique identifier (PO ID) assigned to the institution accruing the patient to the study | CTEP Site ID |
| Study Site Accrual Count | M | N/A | -- |
| Cut-Off Date | O | The date from which the cumulative accrual count was calculated. | (TBD) |
