在已开启访视中未开启的表单，将其视为未完成表单。这适用于所有类型的访视，包括受试者引发的访视。对于可重复表单，如果未开启该表单的第一个实例，则该表单被视为未完成。重置表单会导致该表单处于未完成状态。
Operational Data Model （ODM）是不基于任何平台或系统的交互和存档临床试验数据的格式。该格式包括了临床数据以及其相关的元数据，管理数据，参考值数据和稽查信息。所有需要在不同软件中需要分享的信息包括设置，运行，分析，递交或长期保存信息都在这个模型中。
您可在导出数据的时候选择Viedoc的版本。该选项可以让您导出和之前Viedoc版本一样格式的文件。
注意！
该功能在Viedoc Admin中可选。若您无法查看到，则可能是因为未被激活。
若该选项在Viedoc Admin中激活，您可在
导出格式
下方看到
导出版本
下拉菜单。若您想导出最新Viedoc版本的数据，请选择
Viedoc最新版本:
可供导出的Viedoc版本也会在
最新的导出文件
区域导出。
导出的文件会存有关于Viedoc版本的信息。您可在以下文件中找到：
Excel，请查看
README
的部分。
CSV，请查看
README
的部分。
PDF，每张PDF页脚或右侧会有显示。
ODM，Viedoc版本将显示在导出版本SourceSystemVersion中。
Viedoc
导出版本
中，并不是每一个版本都会显示，
只有
那些版本会影响数据结构的版本会在下拉菜单中。
As of Viedoc release 4.79, the following output versions are available:
Latest Viedoc version
When choosing
Latest Viedoc version
, the exported data will automatically follow the structure of the latest Viedoc release in which changes to the data structure were introduced.
Viedoc 4.79
Introduction of a number of changes to the ODM data export. See the table below for details.
Viedoc 4.77
For studies where item-level SDV is enabled, when exporting review status, the SDV sheet in the CSV and Excel data exports will include only the items that require SDV and are visible to the user. On the Review status sheet, items that do not require SDV are indicated with N/A .
Viedoc 4.68
Introduction of pdf archive export system check which splits the archive into one pdf file per subject and stores resultant PDF in a zip file.
Viedoc 4.67
Introduction of two new columns for approving medical coding: "approved by" and "approved on date".
Viedoc 4.51
Introduction of three new form repeat keys and the table of contents in the PDF export, see the table below for details
Viedoc 4.39
Introduction of repeating forms and recurring events, see the table below for details.
Viedoc 4.38
Original output format (Viedoc versions 4.38 or older).
Introduction of support for partial datetime, date, and time. This is now the default type when exporting designs and data in ODM format. Partial dates as per the ISO 6801 standard are written up to the most detailed value available.
This makes the export compliant with CDISC ODM.
When exporting a design to ODM, multi-selection code lists are handled as follows:
Checkbox item definitions are split by code list items.
During metadata export, checkbox ItemDef is replaced with one for each code list item.
For clinical data export, the comma-separated values are replaced for the checkbox with ItemData for each respective value.
For example, when splitting a checkbox ItemDef with OID="CHK" and code list IDs "Yes" and "No", the split checkbox ItemDefs will have the OIDs "__CHK__Yes" and "__CHK__No", respectively. That is, the original OIDs and the code list IDs are prefixed with two underscore characters and separated by two underscore characters.
In Viedoc Designer, checkbox items are exported as multiple ItemDefs - one for each selection value. In Viedoc Clinic and the Viedoc API: In the latest export version, checkboxes are exported as separate items for metadata and clinical data. In previous export versions, checkboxes are exported as one item.
This has been introduced to be compliant with CDISC ODM.
Bug fix
: In the ODM data export, the content of the Question element for study event items and booklet forms was not complete. According to the CDISC standard, the element should include one of the TranslatedText attributes. This is now solved, and the Question element is populated with a string related to the corresponding OID.
This is applied to all export versions.
Bug fix
: In the ODM data export, the MeasuremetUnit.Name contained HTML code, making it non-compliant with the CDISC standard. This is now solved, and the HTML code is removed from the name.
This is applied to all export versions.
Bug fix
: In the ODM data export, the translated text was missing for meta.Protocol.Description.TranslatedText. This is now solved, and the body is populated with the protocol name, as visible on the design overview page.
This is applied to all export versions.
Bug fix
: In the ODM data export, the Length attribute was incorrect, making it non-compliant with the CDISC standard. This is now solved, and Length is populated as per the ItemDef data type.
This is applied to all export versions.
Bug fix
: In the ODM data export, there was a mismatch between the item data type and the code list data type for checkboxes. This is now solved, and the checkbox data is split into different items, in the same way as for CSV and Excel exports.
This is implemented in a new export version, version 4.79.
Bug fix
: In the ODM data export, the study OID and ClinicalData didn't respect the Production/Demo mode for sites. This is now solved, and the study OID and ClinicalData are populated based on the Production/Demo mode of the exported study.
This is applied without a new export version.
Bug fix
: In the ODM data export, non-repeating forms included a repeat key, making the ODM data export non-compliant with the CDISC standard. This is now solved.
This is implemented in a new export version, version 4.79.
Bug fix
: In the ODM data export, the KeySet elements had an unregistered value for the ItemOID attribute, making the ODM data export non-compliant with the CDISC standard. This is now solved, and the KeySet elements reference items within the same MetaDataVersion.
This is implemented in a new export version, version 4.79.
Bug fix
: In the ODM data export, the attribute OrderNumber of the element StudyEventRef was not valid with respect to its type, integer. This is now solved, and StudyEventRef elements have unique and non-empty consecutive order numbers.
This is applied to all export versions.
Bug fix
: In the ODM data export, there was a data type mismatch between CodeList and ItemDef, making the ODM data export non-compliant with the CDISC standard. This is now solved by always having a matching data type between ItemDef and CodeList.
This is applied to all export versions.
Bug fix
: In the ODM data export, the element MeasurementUnitRef had an unregistered value for the MeasurementUnitOID attribute, making the ODM data export non-compliant with the CDISC standard. This is now solved, and measurement units not referenced in any MetaDataVersion are not included in the ODM data export.
This is applied to all export versions.
Bug fix
: In the ODM data export, the Alias names were not correctly populated. This is now solved, and any code list item aliases with empty names are removed at import and export - and the Alias names are populated with the context values.
This is applied to all export versions.
Bug fix
: In the ODM data export, the SAS field name and the SAS dataset name were not populated. This is now solved, and the SAS field name is populated based on the ItemDef OID, and the SAS dataset name is populated based on the FormDefOID, which means that the OIDs are SAS-compliant. There is an option for this in the data export.
This is applied to all export versions.
Bug fix
: In the ODM data export, revisions linked to study events and revisions linked to forms requiring approval of the new design revision were not included. This is now solved.
This is applied to all export versions.
Bug fix
: In the ODM data export, alerts had repeating order numbers. This is now solved, and the order numbers for all study settings alerts in Viedoc Designer are removed.
This is applied to all export versions.
Bug fix
: In the ODM data export, the item group containing the reference data items was not added to the MetaDataVersion. This is now solved.
This is applied to all export versions.
Addition of three columns for the new form sequence numbers introduced:
SubjectFormSeqNo
– Counter that uniquely identifies the instance of a specific form on a subject level, that is, it starts with 1 and is incremented each time a new instance of the form is created for that subject.
OriginSubjectFormSeqNo
– For a copied form instance, it identifies the form instance from which data was copied for the first time. For the first instance of the form (that is, not copied) it gets the value of the
SubjectFormSeqNo
.
SourceSubjectFormSeqNo
– For a copied form instance, a counter that identifies the source of a copied form instance (the form instance the data was copied from). It gets the value of the
SubjectFormSeqNo
from which the form instance was copied. For the first instance of the form (that is, not copied) it is empty.
Three new form sequence numbers were introduced, as Viedoc extensions:
v4:SubjectFormSeqNo
,
v4:OriginSubjectFormSeqNo
and
v4:SourceSubjectFormSeqNo
, within the
FormData
, right after the
FormRepeatKey
.
A table of contents was added to the PDF archive, starting on page 2 of the file.
Excel
Addition of a column for Form sequence number (
FormSeq
) that contains the
FormRepeatKey
.
The
FormRepeatKey
now contains the activity ID as well, in the following format:
FormRepeatKey$ActivityId
. The ExportVersion attribute has been added to the ODM.
The summary formats are used to display the event and form names.
3
.
可以在紧凑试图和宽松视图间切换。
4
.
单击列标题以按升序对数据进行排序。再次单击则按降序排列。第三次单击则取消列的排序。要重新排列表中列的顺序，只需点击列标题并横向拖拽。
No part of this user guide may be modified, copied or distributed without prior written consent from Viedoc Technologies.
The information contained herein is subject to change without notice. Viedoc Technologies shall not be liable for technical or editorial errors or omissions contained herein.
