01050
Reason Ended Study
2020-01-06
Definition: This information is important for quality control and data analysis. The coding systems will vary among trials. An example answer set is: Adverse Events, Completed Trial, Death, Drug Resistance, Intercurrent Illness, Lost to Follow up, No Response to Therapy, Noncompliance, Progression of Disease, Protocol Violation, Refused Further Therapy. This field is required for the off-study trigger event (C04). Refer to Table 0594 - Reason Ended Study in Chapter 2C for valid values.
LengthNot specified
0594Reason Ended Study (CSR-16)
22 components
| 1 | O | - | Identifier | |
| 2 | O | - | Text | |
| 3 | C | Name of Coding System | ||
| 4 | O | - | Alternate Identifier | |
| 5 | O | - | Alternate Text | |
| 6 | C | Name of Alternate Coding System | ||
| 7 | C | - | Coding System Version ID | |
| 8 | O | - | Alternate Coding System Version ID | |
| 9 | O | - | Original Text | |
| 10 | O | - | Second Alternate Identifier | |
| 11 | O | - | Second Alternate Text | |
| 12 | C | Name of Second Alternate Coding System | ||
| 13 | O | - | Second Alternate Coding System Version ID | |
| 14 | C | - | Coding System OID | |
| 15 | O | - | Value Set OID | |
| 16 | C | - | Value Set Version ID | |
| 17 | C | - | Alternate Coding System OID | |
| 18 | O | - | Alternate Value Set OID | |
| 19 | C | - | Alternate Value Set Version ID | |
| 20 | C | - | Second Alternate Coding System OID | |
| 21 | O | - | Second Alternate Value Set OID | |
| 22 | C | - | Second Alternate Value Set Version ID |