| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Composition
|
EvidenceReport | |||
Slices for category
|
1 .. | Slice: Unordered, Open by pattern:text | ||
category:section01
|
S | 1..1 | ||
text
|
1.. | Required Pattern: Section 1 Protocol Summary | ||
Slices for section
|
3 .. | Slice: Unordered, Open by pattern:code | ||
section:protocolSynopsis
|
S | 1..1 | ||
code
|
||||
text
|
Required Pattern: 1.1 Protocol Synopsis | |||
|
Slices for section
|
6 .. | Slice: Unordered, Open by pattern:code | ||
|
section:objectivesEndpoints
|
S | 1..1 | BackboneElement | |
|
code
|
||||
|
text
|
Required Pattern: Primary and Secondary Objectives and Endpoints | |||
|
text
|
1.. | |||
|
section:overallDesign
|
1..1 | BackboneElement | ||
|
code
|
||||
|
text
|
Required Pattern: Overall Design | |||
|
text
|
1.. | |||
|
section:numberOfArms
|
1..1 | BackboneElement | ||
|
code
|
||||
|
text
|
Required Pattern: Number of Arms | |||
|
text
|
1.. | |||
|
section:blinding
|
1..1 | BackboneElement | ||
|
code
|
||||
|
text
|
Required Pattern: Blinding | |||
|
text
|
1.. | |||
|
section:numberOfParticipants
|
1..1 | BackboneElement | ||
|
code
|
||||
|
text
|
Required Pattern: Number of Participants | |||
|
text
|
1.. | |||
|
section:committees
|
1..1 | BackboneElement | ||
|
code
|
||||
|
text
|
Required Pattern: Committees | |||
|
text
|
1.. | |||
|
section:trialSchema
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 1.2 Trial Schema | |||
|
text
|
1.. | |||
entry
|
Reference (SoaPlanDefinition) | |||
|
section:scheduleOfActivities
|
S | 1..1 | ||
|
code
|
||||
|
text
|
Required Pattern: 1.3 Schedule of Activities | |||
|
text
|
1.. | |||
|
entry
|
Reference (SoaPlanDefinition) | |||
|
Documentation for this format
|
||||