<?xml version="1.0" encoding="UTF-8" ?>

<!-- 
  ************************************************************************
  ProtocolRecordSchema.xsd - XML Schema for electronic transfer of 
  protocol information into the ClinicalTrials.gov Protocol Registration 
  System.
     
  ClinicalTrials.gov
  National Library of Medicine, National Institutes of Health
  Schema Version: 2018.05.08
     
  This schema is subject to change without notice.
    
  DEVELOPER NOTES: 
      Only XML conforming to PRS specifications may be uploaded. 
      Other file types, such as Microsoft Word documents or other types  
      of XML, cannot be uploaded to the PRS. 

      Before attempting to use the PRS XML Upload capability, developers
      should gain a throrough understanding of ClinicalTrials.gov data
      elements, as documented in the Data Element Definitions document.

      Tip: The PRS web interface provides a Download XML function
      (from the Edit Protocol or Select Protocol screens) which
      can be used to obtain examples of valid XML.

      ClinicalTrials.gov makes a test system available to PRS account 
      holders, which many sponsors use to "practice" uploading.  To 
      request an account, contact us at register@clinicaltrials.gov.
       
      In some cases, tag names differ from the labels shown in 
      the PRS web interface and Data Element Definitions.
      Comments are included herein to help correlate names in those
      cases.
     
      As the system has evolved, some tags have been removed.
      While we continue to support most of those tags, it is 
      recommended that sponsors modify their systems to comply
      with the current version of this XML Schema.

  CHANGES:
      03/24/2010: Initial release; replaces clinical_study.dtd
      04/26/2010: Minor corrections
      05/18/2010: Added tag for Expanded Access record NCT number
      07/15/2010: Correction: allow multiple overall (study) officials
      12/21/2010: Added comments on delayed results (resultDisposition)
      08/18/2011: Responsible Party changes
      07/17/2012: Other Pre-Specified Outcome Measures added
      11/29/2012: Patient Registry changes
      12/01/2015: Added "data sharing" data elements
      10/22/2016: Changed "xs:squence" to "xs:all" where possible
      01/18/2017: FDAAA 801 Final Rule changes
      06/29/2017: Added IPD Sharing Statement
      05/08/2018: Correction: irb_info details not always required

  ************************************************************************

  PARTIAL UPLOAD OPTION:

  In a normal XML upload, record(s) are completely replaced by the content
  in the XML file.  A partial upload allows a limited merging capability,
  uploading some data elements while retaining other data elements from
  the previous version of the record.

  *** CAUTION: Partial upload poses a significant risk of accidental
  *** loss of data and thus should only be used if absolutely required, 
  *** completely understood and thoroughly tested on the PRS Test System.

  To perform a partial upload, add the attribute partial_upload="true" to 
  the clinical_study tag.  The XML for each study must include
  the minimum identifying information (org_name and org_study_id).

  In a partial upload, the following tags may either be included in 
  their entirety (along with subtags and content) or ommitted.
	    secondary_id 
	    is_fda_regulated 
	    is_section_801 
	    delayed_posting 
	    is_ind_study 
	    ind_info 
	    brief_title 
	    official_title 
	    sponsors 
	    oversight_info 
	    brief_summary 
	    detailed_description 
	    overall_status 
	    why_stopped 
	    expanded_access_status 
	    start_date 
	    start_date_type
	    last_follow_up_date 
	    last_follow_up_date_type 
	    primary_compl_date 
	    primary_compl_date_type 
	    study_type 
	    interventional_design 
	    observational_design 
	    primary_outcome 
	    secondary_outcome 
	    other_outcome 
	    enrollment 
	    enrollment_type 
	    condition 
	    keyword 
	    arm_group 
	    intervention 
	    eligibility 
	    overall_official 
	    overall_contact 
	    overall_contact_backup 
	    location 
	    ipd_sharing_statement
	    link 
	    reference 
	    study_document
	    verification_date 

  If one of these tags is included in a partial upload, its content 
  completely replaces the corresponding data elements in the record.
  If a tag is either ommitted or empty, the corresponding data elements 
  remain unchanged.  Lists (e.g., location, condition, reference) are
  replaced completely when included in a partial upload.

  In order to delete content from a data element (rather than copying 
  from the previous version), include an otherwise empty tag in the XML
  with the attribute delete="true" as indicated below.  For lists,
  specifying a single tag with delete="true" deletes the entire list.

  *** IMPORTANT: Failure to include partial_upload="true" may result in
  *** permanent loss of data, which may or may not be immediately
  *** apparent.

  The resultDisposition tag, documented in detail in RRSUploadSchema.xsd,
  holds information about Delayed Results Posting.  Once the results
  section has been established in a record, resultDisposition cannot
  be modified.  If it is included in an XML upload in such a case,
  a warning will be included in the Batch Summary Report, indicating
  that Delayed Results Posting information has not been modified.

  If a record has Delayed Results Posting information, that information
  must be released, reviewed and published on ClinicalTrials.gov before
  results information can be added to the record.  This also applies
  to changes made after initial publication.

  ************************************************************************

-->

<xs:schema  
	targetNamespace="http://clinicaltrials.gov/prs" 
	xmlns:prs="http://clinicaltrials.gov/prs" 
	xmlns:rrs="http://clinicaltrials.gov/rrs"
	xmlns:xs="http://www.w3.org/2001/XMLSchema">

  <!-- *** Results Section Details (specified separately) *** -->

  <xs:import 
     namespace="http://clinicaltrials.gov/rrs"
     schemaLocation="RRSUploadSchema.xsd"
  />

  <!-- *** Record Collection *** -->

  <xs:element name="study_collection" type="prs:StudyCollection"/>

  <xs:complexType name="StudyCollection">
    <xs:sequence>
      <xs:element name="clinical_study" type="prs:ClinicalStudy" minOccurs="1" maxOccurs="unbounded" />
    </xs:sequence>
  </xs:complexType>


  <!-- *** Overall Record *** -->

  <xs:complexType name="ClinicalStudy">
    <xs:sequence>

      <!-- *** Protocol Section *** -->

      <xs:element name="id_info" type="prs:IdInfo" />

      <xs:element name="is_fda_regulated" type="prs:TopLevelString" minOccurs="0" />  <!-- DEPRECATED:  yes | no -->
      <xs:element name="is_section_801" type="prs:TopLevelString" minOccurs="0" />    <!-- DEPRECATED:  yes | no -->
      <xs:element name="delayed_posting" type="prs:TopLevelString" minOccurs="0" />   <!-- Unapproved Device?  yes | no -->
		
      <xs:element name="is_ind_study" type="prs:TopLevelString" minOccurs="0" />  <!-- US FDA IND/IDE Study?  yes | no -->
      <xs:element name="ind_info" type="prs:IndInfo" minOccurs="0" />
		
      <xs:element name="brief_title" type="prs:TopLevelString" minOccurs="0" />  <!-- required except in partial upload -->
      <xs:element name="acronym" type="xs:string" minOccurs="0" />
      <xs:element name="official_title" type="prs:TopLevelString" minOccurs="0" />

      <xs:element name="sponsors" type="prs:Sponsors" minOccurs="0" />

      <xs:element name="oversight_info" type="prs:OversightInfo" minOccurs="0" />

      <xs:element name="brief_summary" type="prs:TopLevelTextBlock" minOccurs="0" />
      <xs:element name="detailed_description" type="prs:TopLevelTextBlock" minOccurs="0" />

      <xs:element name="overall_status" type="prs:TopLevelString" minOccurs="0" />  <!-- overall recruitment status:
                                                                                         Not yet recruiting | Recruiting |
										         Active, not recruiting | 
											 Enrolling by invitation | Completed | 
											 Suspended | Terminated | Withdrawn -->
      <xs:element name="why_stopped" type="prs:TopLevelString" minOccurs="0" />
      <xs:element name="expanded_access_status" type="prs:TopLevelString" minOccurs="0" />  <!-- Available | No longer available |
												 Temporarily not available | 
												 Approved for marketing -->
      <xs:element name="verification_date" type="xs:string" minOccurs="0" />                <!-- record verification date: YYYY-MM  -->

      <xs:element name="start_date" type="prs:TopLevelString" minOccurs="0" />  <!-- study start date: YYYY-MM -->
      <xs:element name="start_date_type" type="prs:TopLevelString" minOccurs="0" />  <!-- study start date: YYYY-MM -->

      <xs:element name="end_date" type="xs:string" minOccurs="0" />             <!-- DEPRECATED: use last_follow_up_date instead  -->

      <xs:element name="last_follow_up_date" type="prs:TopLevelString" minOccurs="0" />       <!-- study completion date: YYYY-MM -->
      <xs:element name="last_follow_up_date_type" type="prs:TopLevelString" minOccurs="0" />  <!-- Anticipated | Actual -->

      <xs:element name="primary_compl_date" type="prs:TopLevelString" minOccurs="0" />        <!-- primary completion date: YYYY-MM -->
      <xs:element name="primary_compl_date_type" type="prs:TopLevelString" minOccurs="0" />   <!-- Anticipated | Actual -->


      <xs:element name="study_design" type="prs:StudyDesign" minOccurs="0" />

      <xs:element name="primary_outcome" type="prs:Outcome" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="secondary_outcome" type="prs:Outcome" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="other_outcome" type="prs:Outcome" minOccurs="0" maxOccurs="unbounded" />  <!-- other pre-specified outcome measure -->

      <xs:element name="enrollment" type="prs:TopLevelString" minOccurs="0" />  <!-- number of subjects -->
      <xs:element name="enrollment_type" type="prs:TopLevelString" minOccurs="0" />  	<!-- Anticipated | Actual -->
	
      <xs:element name="condition" type="prs:TopLevelString" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="keyword" type="prs:TopLevelString" minOccurs="0" maxOccurs="unbounded" />
	
      <xs:element name="arm_group" type="prs:ArmGroup" minOccurs="0" maxOccurs="unbounded" />	
      <xs:element name="intervention" type="prs:Intervention" minOccurs="0" maxOccurs="unbounded" />
	
      <xs:element name="eligibility" type="prs:Eligibility" minOccurs="0" />	
	
      <xs:element name="overall_official" type="prs:OverallOfficial" minOccurs="0" maxOccurs="unbounded" />  <!-- study officials -->
      <xs:element name="overall_contact" type="prs:OverallContact" minOccurs="0" />                          <!-- central contact person -->
      <xs:element name="overall_contact_backup" type="prs:OverallContact" minOccurs="0" />

      <xs:element name="location" type="prs:Location" minOccurs="0" maxOccurs="unbounded" />

      <xs:element name="ipd_sharing_statement" type="prs:IPDSharingStatement" minOccurs="0" />	

      <xs:element name="link" type="prs:Link" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="reference" type="prs:Reference" minOccurs="0" maxOccurs="unbounded" />  <!-- citations -->
      <xs:element name="study_document" type="prs:StudyDocument" minOccurs="0" maxOccurs="unbounded" />
          <!-- available study data/document -->


      <!-- *** Results Section (details specified separately via import, above) *** -->

      <xs:element ref="rrs:result" minOccurs="0" />
      <xs:element ref="rrs:resultDisposition" minOccurs="0" />

    </xs:sequence>

    <xs:attribute name="partial_upload" type="xs:boolean" default="false"/>  <!-- see comments above -->

  </xs:complexType>


  <!-- *** Protocol Section Details *** -->

  <xs:complexType name="TopLevelString">
    <xs:simpleContent>
      <xs:extension base="xs:string">
        <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
      </xs:extension>
    </xs:simpleContent>
  </xs:complexType>

  <xs:complexType name="TextBlock">
    <xs:all>
      <xs:element name="textblock" type="xs:string" />  <!-- supports formatting as documented in PRS web interface -->
    </xs:all>
  </xs:complexType>

  <xs:complexType name="TopLevelTextBlock">
    <xs:complexContent>
      <xs:extension base="prs:TextBlock">
        <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>

  <xs:complexType name="IdInfo">
    <xs:sequence>
      <xs:element name="provider_name" type="xs:string" minOccurs="0" />      <!-- PRS INTERNAL USE ONLY 
										   (may be ommitted or left blank) -->
      <xs:element name="provider_study_id" type="xs:string" minOccurs="0" />  <!-- PRS INTERNAL USE ONLY 
										   (may be ommitted or left blank) -->

      <xs:element name="org_name" type="xs:string" />      <!-- short org name used to login to PRS -->
      <xs:element name="org_study_id" type="xs:string" />  <!-- unique protocol id -->

      <xs:element name="secondary_id" type="prs:SecondaryId" minOccurs="0" maxOccurs="unbounded" />
    </xs:sequence>
  </xs:complexType>

  <xs:complexType name="SecondaryId">
    <xs:all>
      <xs:element name="id" type="xs:string" />
      <xs:element name="id_type" type="xs:string" minOccurs="0" />  <!-- NIH Grant Number | Other Grant/Funding Number | 
									 Registry Identifier | EudraCT Number | 
									 Other Identifier -->
      <xs:element name="id_domain" type="xs:string" minOccurs="0" />  <!-- usage depends on id_type:
									   NIH Grant Number: not used
									   Other Grant/Funding Number: grantor name
									   Registry Identifier: registry name
									   EudraCT Number: not used
									   Other Identifier: description -->
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="IndInfo">
    <xs:all>
      <xs:element name="ind_grantor" type="xs:string" />               <!-- FDA Center:  CDER | CBER | CDRH -->
      <xs:element name="ind_number" type="xs:string" />                <!-- IND/IDE Number -->
      <xs:element name="ind_serial_number" type="xs:string" minOccurs="0" />

      <xs:element name="has_expanded_access" type="xs:string"  minOccurs="0" />  <!-- availability:  yes | no | unknown -->
      <xs:element name="expanded_access_nct_id" type="xs:string"  minOccurs="0" />  <!-- expanded access record -->
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="Sponsors">
    <xs:sequence>
      <xs:element name="lead_sponsor" type="prs:Agency" />
      <xs:element name="collaborator" type="prs:Agency" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="resp_party" type="prs:ResponsibleParty"  minOccurs="0" />
    </xs:sequence>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="Agency">
    <xs:all>
      <xs:element name="agency" type="xs:string" />
    </xs:all>
  </xs:complexType>

  <xs:complexType name="ResponsibleParty">
    <xs:all>
      <xs:element name="resp_party_type" type="xs:string" />  <!-- Sponsor | Principal Investigator | Sponsor-Investigator -->

      <!-- investigator_* elements are only used when RP type is one of the 'investigator' options -->
      <xs:element name="investigator_username" type="xs:string" minOccurs="0" />
      <xs:element name="investigator_title" type="xs:string" minOccurs="0" />
      <xs:element name="investigator_affiliation" type="xs:string" minOccurs="0" />

      <xs:element name="name_title" type="xs:string" minOccurs="0" />    <!-- DEPRECATED: use above RP subelements instead  -->
      <xs:element name="organization" type="xs:string" minOccurs="0" />  <!-- DEPRECATED: use above RP subelements instead  -->
      <xs:element name="phone" type="xs:string" minOccurs="0" />         <!-- DEPRECATED: use above RP subelements instead  -->
      <xs:element name="phone_ext" type="xs:string" minOccurs="0" />     <!-- DEPRECATED: use above RP subelements instead  -->
      <xs:element name="email" type="xs:string" minOccurs="0" />         <!-- DEPRECATED: use above RP subelements instead  -->
    </xs:all>
  </xs:complexType>

  <xs:complexType name="OversightInfo">
    <xs:sequence>
      <xs:element name="regulatory_authority" type="xs:string" minOccurs="0" maxOccurs="unbounded" />  <!-- DEPRECATED: no longer used
                                                                                                            oversight authority -->
      <xs:element name="irb_info" type="prs:IrbInfo" minOccurs="0" />
      <xs:element name="has_dmc" type="xs:string" minOccurs="0" />                 <!-- yes | no -->
      <xs:element name="fda_regulated_drug" type="xs:string" minOccurs="0" />      <!-- yes | no -->
      <xs:element name="fda_regulated_device" type="xs:string" minOccurs="0" />    <!-- yes | no -->
      <xs:element name="post_prior_to_approval" type="xs:string" minOccurs="0" />  <!-- yes | no -->
      <xs:element name="exported_from_us" type="xs:string" minOccurs="0" />        <!-- yes | no -->
      <xs:element name="ped_postmarket_surv" type="xs:string" minOccurs="0" />     <!-- yes | no -->
    </xs:sequence>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="IrbInfo">
    <xs:all>
      <xs:element name="approval_status" type="xs:string" />  <!-- Approved | Pending | Exempt | Denied |
								   Not required | Not yet submitted -->
      <xs:element name="approval_number" type="xs:string" minOccurs="0" />  <!-- board approval number -->

      <xs:element name="name" type="xs:string" minOccurs="0" />          <!-- board name, board affiliation, ... -->
      <xs:element name="affiliation" type="xs:string" minOccurs="0"  />
      <xs:element name="phone" type="xs:string" minOccurs="0" /> 
      <xs:element name="phone_ext" type="xs:string" minOccurs="0" /> 
      <xs:element name="email" type="xs:string" minOccurs="0" /> 
      <xs:element name="full_address" type="xs:string" minOccurs="0" />
    </xs:all>
  </xs:complexType>

  <xs:complexType name="StudyDesign">
    <xs:all>
      <xs:element name="study_type" type="prs:TopLevelString" />  <!-- Interventional | Observational | Expanded Access -->

      <xs:element name="interventional_design" type="prs:InterventionalDesign" minOccurs="0" />
          <!-- include iff type==interventional -->

      <xs:element name="observational_design" type="prs:ObservationalDesign" minOccurs="0" />
          <!-- include iff type==observational -->

      <xs:element name="no_exp_acc_type" type="xs:string" minOccurs="0" />              <!-- yes | no   - if yes, exp_acc_type_* should all be no -->
      <xs:element name="exp_acc_type_individual" type="xs:string" minOccurs="0" />      <!-- yes | no -->
      <xs:element name="exp_acc_type_intermediate" type="xs:string" minOccurs="0" />    <!-- yes | no -->
      <xs:element name="exp_acc_type_treatment" type="xs:string" minOccurs="0" />       <!-- yes | no -->

    </xs:all>
  </xs:complexType>


  <xs:complexType name="InterventionalDesign">
    <xs:all>
      <xs:element name="interventional_subtype" type="xs:string" />  <!-- primary purpose: 
									    Treatment | Prevention | 
									    Diagnostic | Basic Science | 
									    Supportive Care | Screening | 
									    Health Services Research | 
									    Device Feasibility | Other -->

      <xs:element name="phase" type="xs:string" />  <!-- Early Phase 1 | Phase [1,1/2,2,2/3,3,4] | N/A 
                                                           Phase 0 == Early Phase 1 -->
		
      <xs:element name="assignment" type="xs:string" minOccurs="0" />  <!-- study design, interventional study model:
									      Single Group Assignment | Parallel Assignment |
									      Crossover Assignment | Factorial Assignment 
									      Sequential Assignment -->
      <xs:element name="model_description" type="prs:TextBlock" minOccurs="0" />   

      <xs:element name="allocation" type="xs:string" />  <!-- Randomized | Non-randomized | N/A -->
		
      <xs:element name="masking" type="xs:string" minOccurs="0" />             <!-- DEPRECATED: use no_masking or masked_* instead -->

      <xs:element name="no_masking" type="xs:string" minOccurs="0" />           <!-- yes | no   - if yes, masked_* should all be no -->
      <xs:element name="masked_subject" type="xs:string" minOccurs="0" />       <!-- yes | no   - participant == subject-->
      <xs:element name="masked_caregiver" type="xs:string" minOccurs="0" />     <!-- yes | no   - care provider == caregiver-->
      <xs:element name="masked_investigator" type="xs:string" minOccurs="0" />  <!-- yes | no -->
      <xs:element name="masked_assessor" type="xs:string" minOccurs="0" />      <!-- yes | no -->
      <xs:element name="masking_description" type="prs:TextBlock" minOccurs="0" />   

      <xs:element name="control" type="xs:string" minOccurs="0" />  <!-- DEPRECATED: no longer used  -->

      <xs:element name="endpoint" type="xs:string" minOccurs="0" />  <!-- DEPRECATED: no longer used  
                                                                          study [endpoint] classification -->

      <xs:element name="number_of_arms" type="xs:string" minOccurs="0" />  <!-- 1 for single-arm study -->	
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="ObservationalDesign">
    <xs:all>
      <xs:element name="observational_study_design" type="xs:string" /> <!-- observational study model:
									       Cohort | Case-Control | Case-Only | Case-Crossover |
									       Ecologic or Community | Family-Based | Other -->

      <xs:element name="biospecimen_retention" type="xs:string" />  <!-- None Retained | Samples With DNA | Samples Without DNA -->

      <xs:element name="biospecimen_description" type="prs:TextBlock" minOccurs="0" />   
          <!-- specify iff biospecimens are being retained -->

      <xs:element name="timing" type="xs:string" />  <!-- time perspective:
							    Retrospective | Prospective | Cross-Sectional | Other -->

      <xs:element name="number_of_groups" type="xs:string" />  <!-- number of groups/cohorts: 
							            1 for single-group/cohort study -->

      <xs:element name="patient_registry" type="xs:string" minOccurs="0" />          <!-- yes | no | true | false
                                                                                          specify target_duration_* if yes -->	
      <xs:element name="target_duration_quantity" type="xs:string" minOccurs="0" />  <!-- Whole number > 0 -->	
      <xs:element name="target_duration_units" type="xs:string" minOccurs="0" />     <!-- Years | Months | Weeks | Days -->	
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="Outcome">
    <xs:all>
      <xs:element name="outcome_measure" type="xs:string" />                     <!-- outcome measure title -->
      <xs:element name="outcome_time_frame" type="xs:string" minOccurs="0" />
      <xs:element name="outcome_description" type="prs:TextBlock" minOccurs="0" />
      <xs:element name="outcome_safety_issue" type="xs:string" minOccurs="0" />  <!-- DEPRECATED: no longer used  -->
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="ArmGroup">
    <xs:all>
      <xs:element name="arm_group_label" type="xs:string" />           <!-- arm title or group/cohort label -->

      <xs:element name="arm_type" type="xs:string" minOccurs="0" />    <!-- specify iff study_type == interventional:
									    Experimental | Active Comparator | 
									    Placebo Comparator | Sham Comparator | 
									    No Intervention | Other -->

      <xs:element name="arm_group_description" type="prs:TextBlock" minOccurs="0" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="Intervention">
    <xs:sequence>
      <xs:element name="intervention_type" type="xs:string" minOccurs="0" />  <!-- Drug | Device | Biological/Vaccine | 
								                   Procedure/Surgery | Radiation | Behavioral | 
								                   Genetic | Dietary Supplement | Other -->
      <xs:element name="intervention_name" type="xs:string" />
      <xs:element name="intervention_description" type="prs:TextBlock" minOccurs="0" />
      <xs:element name="arm_group_label" type="xs:string" minOccurs="0" maxOccurs="unbounded" />
      <xs:element name="intervention_other_name" type="xs:string" minOccurs="0" maxOccurs="unbounded" />
    </xs:sequence>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="Eligibility">
    <xs:all>
      <xs:element name="study_population" type="prs:TextBlock" minOccurs="0" />  <!-- specify iff study_type ==  observational -->

      <xs:element name="sampling_method" type="xs:string" minOccurs="0" />  <!-- specify iff study_type ==  observational:
										   Probability Sample | Non-Probability Sample -->

      <xs:element name="criteria" type="prs:TextBlock" />
  
      <xs:element name="healthy_volunteers" type="xs:string"  minOccurs="0" />  <!-- yes | no -->

      <xs:element name="gender" type="xs:string" />  <!-- sex:  All | Female | Male 
                                                            Both == All -->
      <xs:element name="gender_based" type="xs:string"  minOccurs="0" />  <!-- yes | no -->
      <xs:element name="gender_description" type="prs:TextBlock"  minOccurs="0" />


      <!-- Min/max ages include a whole number followed by units: e.g., "12 Years"
	   Units may be one of: years, months, weeks, days, hours, minutes 
           For no limit, specify "N/A" -->
      <xs:element name="minimum_age" type="xs:string" />
      <xs:element name="maximum_age" type="xs:string" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="OverallOfficial">
    <xs:all>
      <xs:element name="first_name" type="xs:string" minOccurs="0" />
      <xs:element name="middle_name" type="xs:string" minOccurs="0" />
      <xs:element name="last_name" type="xs:string" />
      <xs:element name="degrees" type="xs:string" minOccurs="0" />		
      <xs:element name="role" type="xs:string" minOccurs="0" />  <!-- Principal Investigator | 
								      Study Chair | 
								      Study Director -->
      <xs:element name="affiliation" type="xs:string" minOccurs="0" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="OverallContact">
    <xs:all>
      <xs:element name="first_name" type="xs:string" minOccurs="0" />
      <xs:element name="middle_name" type="xs:string" minOccurs="0" />
      <xs:element name="last_name" type="xs:string" />
      <xs:element name="degrees" type="xs:string" minOccurs="0" />
		
      <xs:element name="phone" type="xs:string" minOccurs="0" />
      <xs:element name="phone_ext" type="xs:string" minOccurs="0" />
      <xs:element name="email" type="xs:string" minOccurs="0" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="Location">
    <xs:sequence>
      <xs:element name="facility" type="prs:Facility" />
      <xs:element name="status" type="xs:string" minOccurs="0" />  <!-- site recruitment status:
                                                                        Not yet recruiting | Recruiting | 
									No longer recruiting | Active, not recruiting | 
									Enrolling by invitation | Completed | 
									Suspended | Terminated | Withdrawn -->

      <xs:element name="contact" type="prs:LocationContact" minOccurs="0" />
      <xs:element name="contact_backup" type="prs:LocationContact" minOccurs="0" />

      <xs:element name="investigator" type="prs:LocationInvestigator" minOccurs="0" maxOccurs="unbounded" />
    </xs:sequence>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="Facility">
    <xs:all>
      <xs:element name="name" type="xs:string" />
      <xs:element name="address" type="prs:Address" />
    </xs:all>
  </xs:complexType>

  <xs:complexType name="Address">
    <xs:all>
      <xs:element name="city" type="xs:string" minOccurs="0" />     <!-- use English spelling -->
      <xs:element name="state" type="xs:string" minOccurs="0" />    <!-- required if country is USA; 
								         use 2 character abbreviation or full spelling -->
      <xs:element name="country" type="xs:string" minOccurs="0" />  <!-- use English spelling; 
								         abbreviations recognized: USA, UK, CAN -->
      <xs:element name="zip" type="xs:string" minOccurs="0" />      <!-- zip/postal code -->
    </xs:all>
  </xs:complexType>

  <xs:complexType name="LocationContact">
    <xs:all>
      <xs:element name="first_name" type="xs:string" minOccurs="0" />
      <xs:element name="middle_name" type="xs:string" minOccurs="0" />
      <xs:element name="last_name" type="xs:string" minOccurs="0" />
      <xs:element name="degrees" type="xs:string" minOccurs="0" />
		
      <xs:element name="phone" type="xs:string" minOccurs="0" />
      <xs:element name="phone_ext" type="xs:string" minOccurs="0" />
      <xs:element name="email" type="xs:string" minOccurs="0" />
    </xs:all>
  </xs:complexType>

  <xs:complexType name="LocationInvestigator">
    <xs:all>
      <xs:element name="first_name" type="xs:string" minOccurs="0" />
      <xs:element name="middle_name" type="xs:string" minOccurs="0" />
      <xs:element name="last_name" type="xs:string" minOccurs="0" />
      <xs:element name="degrees" type="xs:string" minOccurs="0" />

      <xs:element name="role" type="xs:string" minOccurs="0" />  <!-- Principal Investigator | 
							              Sub-Investigator -->
    </xs:all>
  </xs:complexType>


  <xs:complexType name="IPDSharingStatement">
    <xs:sequence>
      <xs:element name="sharing_ipd" type="xs:string" minOccurs="0" />             <!-- yes | no | undecided
                                                                                        plan to share IPD
											formerly under oversight_info -->
      <xs:element name="ipd_description" type="prs:TextBlock" minOccurs="0" />     <!-- specify only if sharing_ipd is specified
                                                                                        plan description
											formerly under oversight_info -->
      <!-- following subelements only apply if sharing_ipd = yes  -->
      <xs:element name="ipd_info_type_protocol" type="xs:string" minOccurs="0" />  <!-- yes | no -->
      <xs:element name="ipd_info_type_sap" type="xs:string" minOccurs="0" />       <!-- yes | no -->
      <xs:element name="ipd_info_type_icf" type="xs:string" minOccurs="0" />       <!-- yes | no -->
      <xs:element name="ipd_info_type_csr" type="xs:string" minOccurs="0" />       <!-- yes | no -->
      <xs:element name="ipd_info_type_analytic_code" type="xs:string" minOccurs="0" />  <!-- yes | no -->
      <xs:element name="ipd_time_frame" type="prs:TextBlock" minOccurs="0" />
      <xs:element name="ipd_access_criteria" type="prs:TextBlock" minOccurs="0" />
      <xs:element name="ipd_url" type="xs:string" minOccurs="0" />
    </xs:sequence>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="Link">
    <xs:all>
      <xs:element name="url" type="xs:string" />
      <xs:element name="description" type="xs:string" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>


  <xs:complexType name="Reference">
    <xs:all>
      <xs:element name="citation" type="xs:string"  minOccurs="0" />        <!-- full bibliographic citation -->
      <xs:element name="pubmed_id" type="xs:string"  minOccurs="0" />       <!-- PubMed (MEDLINE) identifier -->
      <xs:element name="is_results_ref" type="xs:string" minOccurs="0" />   <!-- yes | no -->
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

  <xs:complexType name="StudyDocument">    <!-- IPD and supporting information; fka available study data/document -->
    <xs:all>
      <xs:element name="study_document_type" type="xs:string" />  
          <!-- Individual Participant Data Set | Study Protocol | Statistical Analysis Plan | Informed Consent Form |
	       Clinical Study Report | Analytic Code | Other -->
      <xs:element name="study_document_other_type" type="xs:string" minOccurs="0" />  <!-- specify only if study_document_type = Other -->
      <xs:element name="url" type="xs:string" minOccurs="0" />
      <xs:element name="study_document_identifier" type="xs:string" minOccurs="0" />
      <xs:element name="study_document_comments" type="prs:TextBlock" minOccurs="0" />
    </xs:all>

    <xs:attribute name="delete" type="xs:boolean" default="false" />  <!-- specify only if partial_upload=true 
									   in clinical_study tag -->
  </xs:complexType>

</xs:schema>
