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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 NameMandatory=M; Optional=O
Conditional = C
DefinitionCTRP Accepted ValuesInformation Model Class / Diagram Mapping
Study IdentifierMUnique identifier assigned to the studyNCI, CTEP, or DCP IdentifierStudy Protocol / assignedIdentfier
Study Site IdentifierMUnique identifier (PO ID) assigned to the institution accruing the patient to the studyPO IDStudy Site / identifier
Study Site Accrual CountMNumeric count of subjects accrued at a study site to dateNumericStudy Site / subjectAccrualcount
Cut-Off DateOThe date from which the cumulative accrual count was calculated.YYYYMMDD(TBD)

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Subject Accrual Data Elements Table with CDUS Accepted Values for Abbreviated Trials

 

 
Accrual Data Elements table with CDUS-Accepted values
Accrual Data Element NameMandatory=M; Optional=O
Conditional = C
DefinitionCDUS Accepted Values
Study IdentifierMUnique identifier assigned to the studyCTEP Identifier
Study Site IdentifierMUnique identifier (PO ID) assigned to the institution accruing the patient to the studyCTEP Site  ID
Study Site Accrual CountMN/A--
Cut-Off DateOThe date from which the cumulative accrual count was calculated.(TBD)

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