| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Composition
|
EvidenceReport | |||
Slices for category
|
1 .. | Slice: Unordered, Open by pattern:text | ||
category:section08
|
S | 1..1 | ||
text
|
1.. | Required Pattern: Section 8 Trial Assessments and Procedures | ||
Slices for section
|
9 .. | Slice: Unordered, Open by pattern:code | ||
section:screeningBaseline
|
S | 1..1 | ||
code
|
||||
text
|
Required Pattern: 8.1 Screening/Baseline Assessments and Procedures | |||
|
text
|
1.. | |||
|
section:efficacy
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.2 Efficacy Assessments and Procedures | |||
|
text
|
1.. | |||
|
section:safety
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.3 Safety Assessments and Procedures | |||
|
text
|
1.. | |||
|
section:adverseEvents
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.4 Adverse Events and Serious Adverse Events | |||
|
text
|
1.. | |||
|
section:pregnancy
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.5 Pregnancy and Postpartum Information | |||
|
text
|
1.. | |||
|
section:drugDeviceComplaints
|
S | 0..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.6 Medical Device Product Complaints for Drug/Device Combination Products | |||
|
text
|
1.. | |||
|
section:pharmacokinetics
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.7 Pharmacokinetics | |||
|
text
|
1.. | |||
|
section:genetics
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.8 Genetics | |||
|
text
|
1.. | |||
|
section:biomarkers
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.9 Biomarkers | |||
|
text
|
1.. | |||
|
section:immunogenicity
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.10 Immunogenicity Assessments | |||
|
text
|
1.. | |||
|
section:economics
|
S | 0..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 8.11 Medical Resource Utilisation and 995 Health Economics | |||
|
text
|
1.. | |||
|
Documentation for this format
|
||||