ClinicalData

Attribute Value/Map to Oracle InForm
StudyOID Study Name
MetaDataVersionOID

Study Version

If the form has no study version, MetaDataVersionOID="Undefined."
CriticalItems Includes a separate CriticalItem element for each item-level change that occurs in the Oracle InForm application.

For more information, seeCriticalItem.

How study versions are populated

Study versions are populated in the MetaDataVersionOID field of the ClinicalData element. Per ODM Standard, the Study Version for a form is the study version where the metadata was defined for that form. Oracle InForm Adapter follows that standard.

When data is entered on a revision of a form. Oracle InForm Adapter retrieves the Study Version where that revision of the form was made. This means that a particular transaction that contains updates to multiple forms, where one was modified in Study Version 2 and another in Study Version 3, may return more than one ClinicalData entry in the same transaction.

For example:
  • In Study Version 1, you have Form A, Form B, and Form C.
  • In Study Version 2, you create revision 2 of Form B because you added an item.
  • In Study Version 3, you create revision 2 of Form C because you added a new item group.
These changes result, as follows:
  • Subject 1 is assigned to Site 1, which is using Study Version 3.
  • Rules are defined that cause Form B and Form C to be updated when data is entered on Form A.
  • Form A is submitted for Subject 1 and a transaction is created that updates forms A, B and C.

There will be three ClinicalData sections. Because data was entered into revision 1 of Form A, which was created in Study Version 1 and never changed in 2 or 3, Form A will appear in its own ClinicalData element with MetaDataVersionOID of Study Version 1.

Form B will appear in a separate ClinicalData element with MetaDataVersionOID of Study Version 2.

Form C will appear in a separate ClinicalData element with MetaDataVersionOID of Study Version 3.

The purpose of the MetaDataVersionOID in the ClinicalData element of the transactional ODM is to give you a reference into the Metadata XML so that you can find the correct definition of the form. Therefore, in each of these cases you are given the correct MetaDataVersionOID for the correct study version that contains the definition of what items, etc., are in that revision of the form.

Example

<ClinicalData StudyOID="Depression Study Update" MetaDataVersionOID="Study Version 1.0"
      />
Example of ClinicalData Sample Output
<ClinicalData StudyOID="StudyDesign" MetaDataVersionOID="Study Design 1.0.0"
      pf:TransactionGuid="{77623113-44B5-426B-8365-5DC1397907E8}"
      pf:Revision="246900814798022.000">      <SubjectData SubjectKey="13895" TransactionType="Upsert"
      pf:GUID="{20358FB6-4C41-4DC5-8FAC-02CE2B459C4A}">        <SiteRef LocationOID="13081" />        <StudyEventData StudyEventOID="enroll">          <FormData FormOID="frmEnr">            <ItemGroupData ItemGroupOID="frmEnr.sctSubjectNumber">              <ItemData
      ItemOID="frmEnr.sctSubjectNumber.SubjectNumber_Enr.SubjectNumber_Enr" Value="1">                <AuditRecord>                  <UserRef UserOID="enen" />                  <LocationRef LocationOID="13081" />                  <DateTimeStamp>2008-10-28T20:33:34+00:00</DateTimeStamp>                  <ReasonForChange>Enrollment Entry</ReasonForChange>                  <SourceID>RDINFAPP001281</SourceID>                </AuditRecord>              </ItemData>            </ItemGroupData>          </FormData>        </StudyEventData>      </SubjectData>    </ClinicalData>

Parent topic: ODM mapping