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When a trial has accrued many subjects, rather than entering the data subject-by-subject via the user interface (UI), you can upload all study subject data into CTRP using a batch file upload. The information that follows provides all the details you need to create a CTRP Accruals Batch file.

Use the Batch File Utility as a guide

If you are new to the batch file creation process, you can use the CTRP Accrual Batch File Tool to get you started. With it you can produce properly-formatted batch files that you can upload in the Accrual application.

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)

After you have prepared a batch file, you can upload it to CTRP.  For instructions on submitting batch files, see  Uploading CTRP Subject Accrual Batch Data Files .

Key Facts about CTRP Accrual Batch Files

This section provides a summary of key facts about preparing CTRP Accrual batch files.

  • The CTRP Accrual Batch File format is based on the CTEP Clinical Data Update System (CDUS) file format. You can obtain a copy of the CDUS Instructions and Guidelines, which explains the CDUS file format in great detail, at the CTEP web site at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm.
  • Although the CTRP accrual batch file format is CDUS-compatible, CTRP captures a subset of all the CDUS required data elements.   Comparison of CTRP and CDUS Accrual Data Elements provides a list of all the CDUS fields with a note next to each field indicating whether CTRP captures it.

  • Different data elements are required and expected when submitting accrual data to CTRP for Complete trials (National, Externally Peer Reviewed, and Institutional) than for Abbreviated Trials (Industrial). Instructions are provided below for preparing batch files for both Complete and Abbreviated Trials.

  • A CTRP accrual batch file is a TXT (.txt) file with fields delimited (separated) by commas.

  • Each CTRP batch text file contains accrual data for a single trial.

  • You can compress one or more CTRP accrual batch text files into a single Zip file and then upload this Zip file into CTRP.  CTRP will unzip the file and process each TXT file. Your Zip file can include batch files for both Complete and Abbreviated Trials.

    Do not include the following items in Zip files that you intend to upload:

    • Folders or other Zip files
    • Path names. Some ZIP/compression tools provide an option to include the entire file path name when compressing a file. Path names describe the location of the file.
  • Each batch submission uploaded into CTRP is treated as an update to existing records or as an addition of new ones.

     

If you upload data to a trial that already has accrual data, the batch file is considered an update. The system compares your new data to existing data using identifiers. When the identifiers match, existing data in CTRP is updated. When there are no matching identifiers, data is added to the existing trial.  For Abbreviated trials, the system updates the accrual counts.

An Introduction to Batch Files

This section provides general background information about batch file structure. Subsequent sections provide specific details about the CTRP Subject Accrual Batch file structure.

Each line of text in a batch file corresponds to one record that consists of various required or optional data elements. Each data element is separated by a comma.

Traditional Table Structure

Column 1Column 2Column 3Column 4
Row 1-Field 1Row 1-Field 2Row 1-Field 3Row 1-Field 4
Row 2-Field 1Row 2-Field 2Row 2-Field 3Row 2-Field 4

Corresponding Comma-Delimited Structure

Comma-Delimited Structure
Fields Required for CDUS Records
Fields Required for CTRP Batch File

In a traditional table grid structure, the column headings indicate the order in which the field values occur. In CTRP batch files, the column heading is implicit, and the field order is sequential from left to right, beginning at Field 1.

Traditional Table Structure

Column 1Column 2Column 3Column 4
Row 1-Field 1Row 1-Field 2Row 1-Field 3Row 1-Field 4
Comma-Delimited Structure

The first field in each record is reserved for the table name, which is always in CAPITAL letters. The exact field number for each data element is provided in the Complete Trial Record Data Field Requirements and Abbreviated Trial Record Data Field Requirements tables.

Example - Using Automobiles Instead of Patients

Suppose CDUS stores information about cars (rather than accrued patients) in its database in a table called AUTOMOBILES.

In this example, CDUS records each of the following six data elements:

  • Table Name
  • VIN (Vehicle Identification Number)
  • Make
  • Model
  • Color
  • Year

These data elements are arranged in the following sequence:

Table NameVINMakeModelColorYear

The corresponding comma-delimited sequence is as follows:

Comma-Delimited Data Elements

A traditional table structure for these CDUS data elements and their values are shown below.

Table NameVINMakeModelColorYear
AUTOMOBILEABC-123456FordMustangBlack1965

The corresponding comma-delimited structure is as follows:

Comma-Delimited Data Values

And, to extend this example, suppose that CTRP does not capture the Model nor Color of the car. In this case, the final record in the CTRP batch file would be as follows:

Comma-Delimited CTRP Data Values

File Naming Conventions

The CTRP Accrual Batch File is a TEXT file with fields delimited (separated) by commas. The file can have any name. However, we recommend using the following file naming conventions:
NCI Protocol Number_date.txt (with the date format: YYYYMMDD)

Example File Name

The total number of characters in the file name including the file path must be less than or equal to 260. Use the file extensions .txt (for a single file) or .zip for compressed .txt files.

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