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The following table lists the data fields by the table in which they are recorded. It also provides the field number (field position in a row); and the format and character limits for each field. 

TablesField (Field Position in a Row)Format (Maximum Number of Characters)

COLLECTIONS

Study Identifier (2)

Text (35)

COLLECTIONSChange Code (11)Number (1)

PATIENTS

Study Identifier (2)

Text (35)

PATIENTSStudy Subject Identifier (3)Text (20)

PATIENTS

ZIP Code (4)

Text (10)

PATIENTS

Country of Residence (5)

Text (2)

PATIENTS

Patient's Date of Birth (6)

Date (YYYYMM)

PATIENTS

Gender of a Person (7)

Text (10)

PATIENTS

Ethnicity (8)

Text (25)

PATIENTS

Payment Method (9)

Text (50)

PATIENTS

Subject Registration Date (10)

Date (YYYYMMDD)

PATIENTSRegistering Group Identifier (11)

Text (25)

PATIENTS

Study Site Identifier (12)

Text (25)

PATIENTS

Subject Disease Code (22) 1

Number (10)

PATIENT_RACES

Study Identifier (2)

Text (35)

PATIENT_RACESStudy Subject Identifier (3)Text (20)

PATIENT_RACES

Race (4)

Text (45)

The relation between COLLECTIONS, PATIENTS, and PATIENT_RACES is that COLLECTIONS can have multiple PATIENTS, and PATIENTS can have multiple PATIENT_RACES. These relations are maintained through the use of consistent Study Identifier and Study Subject Identifier fields.

Using the format table, you can determine that you must enter the Patient's Date of Birth in the sixth position in a row in the PATIENTS table as YYYYMM. The following diagram contains a typical line of text from a batch file. Brackets with numbers indicate the field position number.

batch file field format

In the example above, the fifth field position (5) is null (blank) because it (Country of Residence) is a conditionally required field and in this example is not required.

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  1. For trials using ICD-O-3 terminology, use this position for Site and/or Histology Codes. When using both Site and Histology codes, separate them by a semicolon ( ; ).

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