| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Composition
|
EvidenceReport | |||
Slices for category
|
1 .. | Slice: Unordered, Open by pattern:text | ||
category:section05
|
S | 1..1 | ||
text
|
1.. | Required Pattern: Section 5 Trial Population | ||
Slices for section
|
6 .. | Slice: Unordered, Open by pattern:code | ||
section:description
|
S | 1..1 | ||
code
|
||||
text
|
Required Pattern: 5.1 Selection of Trial Population | |||
|
text
|
1.. | |||
entry
|
Reference (Cohort Definition) | |||
|
section:rationale
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 5.2 Rationale for Trial Population | |||
|
text
|
1.. | |||
|
entry
|
Reference (Cohort Definition) | |||
|
section:inclusionCriteria
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 5.3 Inclusion Criteria | |||
|
text
|
1.. | |||
|
entry
|
Reference (Cohort Definition) | |||
|
section:exclusionCriteria
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 5.4 Exclusion Criteria | |||
|
text
|
1.. | |||
|
entry
|
Reference (Cohort Definition) | |||
|
section:lifestyle
|
S | 0..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 5.5 Lifestyle Considerations | |||
|
text
|
1.. | |||
|
section:screenFailures
|
S | 0..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 5.6 Screen Failures | |||
|
text
|
1.. | |||
|
Documentation for this format
|
||||