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.
| Tables | Field (Field Position in a Row) | Format (Maximum Number of Characters) |
|---|---|---|
| COLLECTIONS | Study Identifier (2) | Text (35) |
| COLLECTIONS | Change Code (11) | Number (1) |
| PATIENTS | Study Identifier (2) | Text (35) |
| PATIENTS | Study 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) |
| PATIENTS | Registering 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_RACES | Study 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.
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.
- The ninth field position (9) is null (blank) because it (Payment Method) is no longer a field that can be inputted.
- The eleventh field position (11) is null (blank) because it (Registering Group Identifier) is no longer a field that can be inputted.
Footnote for Subject Disease Code (22)
- For trials using ICD-O-3 terminology, use this position for Site and Histology Codes. The Site and Histology codes should be separated by a semicolon ( ; ). Example given: 8543/3;C50.4 ↩
2 Comments
Izbicki, Michael (NIH/NCI) [C]
Tate, Ariana (NIH/NCI) [C] for ICD-O-3 both site and histology codes are needed so this read:
For trials using ICD-O-3 terminology, use this position for Site and Histology Codes. The Site and Histology codes should be separated by a semicolon ( ; ).
I might be good to also add an example here like: 8543/3;C50.4 (note histology is first)
Tate, Ariana (NIH/NCI) [C]
Updated the footnote.