01047
Stratum for Study Randomization
2020-01-06
Definition: Many studies have stratified randomization schemas. The strata codes must be developed for each clinical trial. This field is important for statistical analysis of the study results. The second and third repetitions will correspond to the second and third repetitions of CSR-11 Study Randomization Date/Time and CSR-12 Randomized Study Arm, if they exist. Refer to Table 0592 - Stratum for Study Randomization in Chapter 2C for valid values.
LengthNot specified
0592Stratum for Study Randomization (CSR-13)
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 |