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Merge pull request #10 from PharmCat/dev
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docs, minor changes
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PharmCat committed Jan 19, 2023
2 parents d5fa071 + 4f535cb commit 69ec243
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14 changes: 7 additions & 7 deletions docs/src/odm/clinicaldata.md
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## Body
### Body

(SubjectData*, AuditRecords*, Signatures*, Annotations*)
(SubjectData*, AuditRecords*, Signatures*, Annotations*)

## Attributes
### Attributes

* StudyOID oidref References the Study that uses the data nested within this element.
* MetaDataVersionOID oidref References the MetaDataVersion (within the above Study) that governs the data nested within this element.
* StudyOID oidref References the Study that uses the data nested within this element.
* MetaDataVersionOID oidref References the MetaDataVersion (within the above Study) that governs the data nested within this element.

## Contained in
### Contained in

* ODM
* ODM

Clinical data for multiple subjects.

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21 changes: 11 additions & 10 deletions docs/src/odm/event.md
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## Body
### Body

(Description?, FormRef*, Alias*)
(Description?, FormRef*, Alias*)

## Attributes
### Attributes

* OID oid
* Name name
* Repeating (Yes | No)
* Type (Scheduled | Unscheduled | Common)
* Category text (optional)
* OID oid
* Name name
* Repeating (Yes | No)
* Type (Scheduled | Unscheduled | Common)
* Category text (optional)

## Contained in

* MetaDataVersion
### Contained in

* MetaDataVersion

A StudyEventDef packages a set of forms. Scheduled Study Events correspond to sets of forms that are expected to be collected for each subject as part of the planned visit sequence for the study. Unscheduled Study Events are designed to collect data that may or may not occur for any particular subject such as a set of forms that are completed for an early termination due to a serious adverse event. A common Study Event is a collection of forms that are used at several different data collection events such as an Adverse Event or Concomitant Medications log.

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16 changes: 8 additions & 8 deletions docs/src/odm/form.md
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## Body
### Body

(Description?, ItemGroupRef*, ArchiveLayout*, Alias*)
(Description?, ItemGroupRef*, ArchiveLayout*, Alias*)

## Attributes
### Attributes

* OID oid
* Name name
* Repeating (Yes | No)
* OID oid
* Name name
* Repeating (Yes | No)

## Contained in
### Contained in

* MetaDataVersion
* MetaDataVersion

A FormDef describes a type of form that can occur in a study.

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28 changes: 14 additions & 14 deletions docs/src/odm/item.md
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## Body
### Body

(Description?, Question?, ExternalQuestion?, MeasurementUnitRef*, RangeCheck*, CodeListRef?, Role* Deprecated, Alias*)
(Description?, Question?, ExternalQuestion?, MeasurementUnitRef*, RangeCheck*, CodeListRef?, Role* Deprecated, Alias*)

## Attributes
### Attributes

* OID oid
* Name name
* DataType (text | integer | float | date | time | datetime | string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float | partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime | incompleteDatetime | incompleteDate | incompleteTime | URI )
* Length positiveInteger (optional)
* SignificantDigits nonNegativeInteger (optional)
* SASFieldName sasName (optional)
* SDSVarName sasName (optional)
* Origin text (optional)
* Comment text (optional)
* OID oid
* Name name
* DataType (text | integer | float | date | time | datetime | string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float | partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime | incompleteDatetime | incompleteDate | incompleteTime | URI )
* Length positiveInteger (optional)
* SignificantDigits nonNegativeInteger (optional)
* SASFieldName sasName (optional)
* SDSVarName sasName (optional)
* Origin text (optional)
* Comment text (optional)

# Contained in
### Contained in

* MetaDataVersion
* MetaDataVersion

An ItemDef describes a type of item that can occur within a study. Item properties include name, datatype, measurement units, range or codelist restrictions, and several other properties.

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30 changes: 15 additions & 15 deletions docs/src/odm/itemgroup.md
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## Body
### Body

(Description?, ItemRef*, Alias*)
(Description?, ItemRef*, Alias*)

## Attributes
### Attributes

* OID oid
* Name name
* Repeating (Yes | No)
* IsReferenceData (Yes | No) (optional)
* SASDatasetName sasName (optional)
* Domain text (optional)
* Origin text (optional)
* Role name (optional) Deprecated
* Purpose text (optional)
* Comment text (optional)
* OID oid
* Name name
* Repeating (Yes | No)
* IsReferenceData (Yes | No) (optional)
* SASDatasetName sasName (optional)
* Domain text (optional)
* Origin text (optional)
* Role name (optional) Deprecated
* Purpose text (optional)
* Comment text (optional)

## Contained in
### Contained in

* MetaDataVersion
* MetaDataVersion

An ItemGroupDef describes a type of item group that can occur within a study.

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16 changes: 8 additions & 8 deletions docs/src/odm/metadata.md
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## Body
### Body

(Include?, Protocol?, StudyEventDef*, FormDef*, ItemGroupDef*, ItemDef*, CodeList*, ImputationMethod*Deprecated, Presentation*, ConditionDef*, MethodDef*)
(Include?, Protocol?, StudyEventDef*, FormDef*, ItemGroupDef*, ItemDef*, CodeList*, ImputationMethod*Deprecated, Presentation*, ConditionDef*, MethodDef*)

## Attributes
### Attributes

* OID oid
* Name name
* Description text (optional)
* OID oid
* Name name
* Description text (optional)

## Contained in:
### Contained in:

* Study
* Study

A metadata version defines the types of study events, forms, item groups, and items that form the study data.

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38 changes: 20 additions & 18 deletions docs/src/odm/odm.md
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# ODM
### ODM

Description of main structural parts provided bellow. Only few elements descibed and only for imformation purpose. **An official version of ODM specificatoion document is available on the ODM page of the CDISC website http://www.cdisc.org/odm.**
Description of main structural parts provided bellow. Only few elements descibed and only for imformation purpose.

**An official version of ODM specificatoion document is available on the ODM page of the CDISC website http://www.cdisc.org/odm.**

## Body

### Body

(Study*, AdminData*, ReferenceData*, ClinicalData*, Association*, ds:Signature*)

## Attributes

* Description text (optional) The sender should use the Description attribute to record any information that will help the receiver interpret the document correctly.
* FileType ( Snapshot | Transactional ) Snapshot means that the document contains only the current state of the data and metadata it describes, and no transactional history. A Snapshot document may include only one instruction per data point. For clinical data, TransactionType in a Snapshot file must either not be present or be Insert. Transactional means that the document may contain more than one instruction per data point. Use a Transactional document to send both what the current state of the data is, and how it came to be there.
* Granularity ( All | Metadata | AdminData | ReferenceData | AllClinicalData | SingleSite | SingleSubject ) (optional) Granularity is intended to give the sender a shorthand way to describe the breadth of the information in the document, for certain common types of documents. All means the entire study; Metadata means the MetaDataVersion element; AdminData and ReferenceData mean the corresponding elements; AllClinicalData, SingleSite, and SingleSubject are successively more tightly focused subset of the study's clinical data. If these shorthand categories are not sufficient, use the Description attribute to give details.
* Archival (Yes | No) (optional) Set this attribute to Yes to indicate that the file is intended to meet the requirements of an electronic record as defined in 21 CFR 11. See Single Files and Collections for an fuller discussion of the meaning of this attribute, as well as its interaction with other ODM attributes.
* FileOID oid A unique identifier for this file.
* CreationDateTime datetime Time of creation of the file containing the document.
* PriorFileOID oidref (optional) Reference to the previous file (if any) in a series.
* AsOfDateTime datetime (optional) The date/time at which the source database was queried in order to create this document.
* ODMVersion ( 1.2 | 1.2.1 | 1.3 | 1.3.1 | 1.3.2 ) (optional) The version of the ODM standard used.
* Originator text (optional) The organization that generated the ODM file.
* SourceSystem text (optional) The computer system or database management system that is the source of the information in this file.
* SourceSystemVersion text (optional) The version of the "SourceSystem" above.
* ID ID (optional) May be used by the ds:Signature element to refer back to this element.
### Attributes

* Description text (optional) The sender should use the Description attribute to record any information that will help the receiver interpret the document correctly.
* FileType ( Snapshot | Transactional ) Snapshot means that the document contains only the current state of the data and metadata it describes, and no transactional history. A Snapshot document may include only one instruction per data point. For clinical data, TransactionType in a Snapshot file must either not be present or be Insert. Transactional means that the document may contain more than one instruction per data point. Use a Transactional document to send both what the current state of the data is, and how it came to be there.
* Granularity ( All | Metadata | AdminData | ReferenceData | AllClinicalData | SingleSite | SingleSubject ) (optional) Granularity is intended to give the sender a shorthand way to describe the breadth of the information in the document, for certain common types of documents. All means the entire study; Metadata means the MetaDataVersion element; AdminData and ReferenceData mean the corresponding elements; AllClinicalData, SingleSite, and SingleSubject are successively more tightly focused subset of the study's clinical data. If these shorthand categories are not sufficient, use the Description attribute to give details.
* Archival (Yes | No) (optional) Set this attribute to Yes to indicate that the file is intended to meet the requirements of an electronic record as defined in 21 CFR 11. See Single Files and Collections for an fuller discussion of the meaning of this attribute, as well as its interaction with other ODM attributes.
* FileOID oid A unique identifier for this file.
* CreationDateTime datetime Time of creation of the file containing the document.
* PriorFileOID oidref (optional) Reference to the previous file (if any) in a series.
* AsOfDateTime datetime (optional) The date/time at which the source database was queried in order to create this document.
* ODMVersion ( 1.2 | 1.2.1 | 1.3 | 1.3.1 | 1.3.2 ) (optional) The version of the ODM standard used.
* Originator text (optional) The organization that generated the ODM file.
* SourceSystem text (optional) The computer system or database management system that is the source of the information in this file.
* SourceSystemVersion text (optional) The version of the "SourceSystem" above.
* ID ID (optional) May be used by the ds:Signature element to refer back to this element.


An element group consists of one or more element names (or element groups) enclosed in parentheses, and separated with commas or vertical bars. Commas indicate that the elements (or element groups) must occur in the XML sequentially in the order listed in the group. Vertical bars indicate that exactly one of the elements (or element groups) must occur. An element or element group can be followed by a ? (meaning optional), a * (meaning zero or more occurrences), or a + (meaning one or more occurrences).
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10 changes: 5 additions & 5 deletions docs/src/odm/study.md
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## Body
### Body

(GlobalVariables, BasicDefinitions?, MetaDataVersion*)

## Attributes
### Attributes

* OID oid
* OID oid

## Contained in
### Contained in

* ODM
* ODM

This element collects static structural information about an individual study.

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2 comments on commit 69ec243

@PharmCat
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Registration pull request created: JuliaRegistries/General/76018

After the above pull request is merged, it is recommended that a tag is created on this repository for the registered package version.

This will be done automatically if the Julia TagBot GitHub Action is installed, or can be done manually through the github interface, or via:

git tag -a v0.4.0 -m "<description of version>" 69ec243e59766c0fb42a6c94dab3ddbedb365b11
git push origin v0.4.0

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