Study Subject Data StudySubjectData_ No SubjectData_ No No No No No No No 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Person Device 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 StudyObservations 1 0 0 0 0 No 0 0 0 No 0 1 StudyObservations 0 0 ByEncounter 0 0 0 0 No 0
Person Person Authoring Device Device @namespace xforms url(http://www.w3.org/2002/xforms); xforms|upload[appearance='open'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open'); } xforms|upload[appearance='open2'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open2'); } xforms|upload[appearance='open3'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open3'); } xforms|upload[appearance='saveas'] { -moz-binding:url('./xbl/FileSaveXBL.xml#saveas'); } initialize(); HL7 Study Data - Subject Data XForm v1.0.0 `Copyright © 2010 U.S. Food and Drug Administration` Save Show Hints Hide Hints Document Subject Subject Narrative Author Copyright notice Document Information A structured document can be replaced by a new document and/or appended with an addendum. The initial version of a document gets, in addition to a new unique value for StructuredDocument.id, a new value for StructuredDocument.setId, and has the value of StructuredDocument.versionNumber set to equal "1". A replacement document gets a new globally unique StructuredDocument.id value, and uses the same value for StructuredDocument.setId as the parent document being replaced, and increments the value of StructuredDocument.versionNumber by 1. (Note that version number must be incremented by one when a document is replaced, but can also be incremented more often to meet local requirements.) Link to Study Design Imports the Planned Study (Study Design) Message. Imports the Study Participation Message. Correct Study Design and Study Participation Messages Loaded. Study Identifier Study Design Identifier: Identifies the study. This ID is used to link the Planned Study to the performed protocols. After importing the Study Design message, this value cannot be changed. Study Name Study Design Name: The Planned Study name. After importing the Study Design message, this value cannot be changed. Document Study Identifier * Study Identifier: The unique instance identifier for this Study Document Identifier * Document Identifier: The unique instance identifier for this Document Document Title Creation Date * (yyyymmdd) Creation Date: The date attribute records the timeframe in which the document contents are valid or relevant for the provision of care. Where the document is a transform from an original document in some other format, the date is the time the original document is created Document Set Identifier Set Identifier: Records the set of versions of this document. Note: Each version instance will have a unique identifier and version number, but the setId should be in common. Version Number Version Number: The version number attribute is an increasing numeric sequence recording successive versions of a document. Related Document The relatedDocument relationship records this document's relationship to preexisting documents. The relatedDocument represents the source of a document revision, addenda, or transformation. relatedDocument text is modeled as an ED data type - allowing for the expression of the MIME type of the parent document and references to it. It shall not to be used to embed the related document. Document Identifier * Document Relationship * Document Set ID Version Number Replaces RPLC Appends APND Transforms XFRM Delete Add Related Document Document Subject Subject Narrative Author Copyright notice Research Subject Information The subject of the acts described in the document. Subject * Subject * Subject * Document Subject Subject Narrative Author Copyright notice Subject Narrative Subject: Summary Narrative: Document Subject Subject Narrative Author Copyright notice Author Information The author participation records the person(s) or machine(s) that originated the document. An author is one who creates a document by entry of information from their own knowledge or application of skills. Assigned Author - Author Identifier * Begin Date (yyyymmdd) End Date(yyyymmdd) Street Address City State PostalCode Country None 0 Person Person Authoring Device Device None 0 Person Person Authoring Device Device First Name Last Name Suffix None 0 Person Person Authoring Device Device Model Name Software Name Represented Organization Org ID (DUNS #) * Organization Name Delete Street Address City State PostalCode Country Add Represented Org Delete Author Add Author Document Subject Subject Narrative Author Performer DataEnterer Verifier Copyright notice Performer Information The entity responsible for performing the acts described within the document. . Assigned Performer - Performer Identifier * Begin Date (yyyymmdd) End Date(yyyymmdd) Street Address City State PostalCode Country None 0 Person Person Authoring Device Device None 0 Person Person Authoring Device Device First Name Last Name Suffix None 0 Person Person Authoring Device Device Model Name Software Name Represented Organization Org ID (DUNS #) * Organization Name Delete Street Address City State PostalCode Country Add Represented Org Delete Performer Add Performer Document Subject Subject Narrative Author Performer DataEnterer Verifier Copyright notice Data Enterer The person responsible for entering the content, possibly transferring it from another source (e.g., transcription). Data Enterer - Assigned Person Information Data Enterer Identifier* First Name Last Name Suffix Begin Date (yyyymmdd) End Date (yyyymmdd) Street Address City State PostalCode Country Represented Organization Org ID (DUNS #) * Organization Name Delete Street Address City State Postal Code Country Add Represented Org Licenses / Degrees License/Degree Type * Org ID (DUNS #) * Organization Name Start Date (yyyymmdd) End Date (yyyymmdd) Delete Street Address City State Postal Code Country Add License/Degree Delete Data Enterer Add Data Enterer Document Subject Subject Narrative Author Performer DataEnterer Verifier Copyright notice Verifier Information The persons that verify or review the content of the document. Verifier - Assigned Person Information Verifier Identifier* First Name Last Name Suffix Begin Date (yyyymmdd) End Date (yyyymmdd) Street Address City State Postal Code Country Represented Organization Org ID (DUNS #) * Organization Name Delete Street Address City State Postal Code Country Add Represented Org Licenses / Degrees License/Degree Type * Org ID (DUNS #) * Organization Name Start Date (yyyymmdd) End Date (yyyymmdd) Delete Street Address City State Postal Code Country Add License/Degree Delete Verifier Add Verifier Document Subject Subject Narrative Author Copyright notice Copyright Notice Copyright (c) 2010 U.S. Food and Drug Administration

Permission is hereby granted, free of charge, to any person obtaining a copy of this software (Study Design XForm) and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, or sell copies of the Software or derivatives, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

Copyright (c) 2010 U.S. Food and Drug Administration

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. THIS SOFTWARE IS PROVIDED WITHOUT ANY OBLIGATION TO PROVIDE MAINTENANCE OR OTHER SUPPORT."