Core Resources

Clinical Data

Often times you’ll want to work with the clinical data of your studies. The Medidata.RWS.NET library provides several requests for extracting clinical data (via RAVE “Clinical Views”) or POSTing clinical data to the RAVE platform.

ClinicalStudiesRequest

Returns a list of EDC studies (as a RWSStudies object). Excludes studies that you (the authenticated user) are not associated with.

Example:

using Medidata.RWS.Core.Requests.Implementations;

//Create a connection
var connection = new RwsConnection("innovate", "username", "password"); // authentication required

//Send the request / get a response
var response = connection.SendRequest(new ClinicalStudiesRequest()) as RWSStudies;

//Write the study list to the console
foreach (var s in response)
{
    Console.Write(s.OID + "\r\n");
}
//Mediflex(Prod)
//Mediflex(Dev)
//PlaceboTest(Prod)
//...

StudySubjectsRequest

Returns a listing of all the subjects in a study (as a RWSSubjects object), optionally including those currently inactive or deleted. Clinical data for the subjects is not included in the response.

This is the equivalent of calling: https://{subdomain}.mdsol.com/studies/{study-oid}/Subjects[?status=all&include={inactive|inactiveAndDeleted}]

Parameters

Parameter	Description	Mandatory?
{study-oid}	The study name.	Yes
status={true | false}	If true, add subject level workflow status to the response (if present).	No
include= {inactive | deleted | inactiveAndDeleted}	Will include active, inactive and/or deleted subjects in the response.	No
subjectKeyType= {SubjectName | SubjectUUID}	Whether RWS should return the unique identifier (UUID) or the subject name.	No
links={true | false}	If true, includes “deep link”(s) (e.g. URLs) to the subject page in Rave in the response.	No

Example:

using Medidata.RWS.Core.Requests.Implementations;

//Create a connection
var connection = new RwsConnection("innovate", "username", "password"); // authentication required

//Send the request / get a response
var response = connection.SendRequest(new StudySubjectsRequest("Mediflex", "Prod")) as RWSSubjects;

//Write each subject key to the console
foreach (var s in response)
{
    Console.Write(s.SubjectKey + "\r\n");
}
// SUBJECT001
// SUBJECT002
// SUBJECT003
// ...

Clinical View Datasets

In addition to the above requests, Medidata RAVE Web Services allows for the extraction of clinical data in the form of “Clinical Views” - that is, RAVE database views. There are 3 “Datasets” available that represent different subsets of clinical data for your studies:

StudyDatasetRequest

Clinical data in ODM format for the given study / environment. This data can be optionally filtered by a specific Form.

This is the equivalent of calling: https://{subdomain}.mdsol.com/studies/{project}({environment})/datasets/{ regular|raw }?{options}

or, to filter the data by form: https://{subdomain}.mdsol.com/studies/{project}({environment})/datasets/{ regular|raw }/{ formoid }?{options}

Example:

using Medidata.RWS.Core.Requests
using Medidata.RWS.Core.Requests.Datasets;

//Create a connection
var connection = new RwsConnection("innovate", "username", "password"); // authentication required

//Send the request / get a response
var response = connection.SendRequest(new StudyDatasetRequest("Mediflex", "Prod", dataset_type: "regular")) as RWSResponse;

//Write the XML response to the console (see XML below)
Console.Write(response.RawXMLString());

<?xml version="1.0" encoding="utf-8"?>
<ODM FileType="Snapshot" FileOID="92747321-c8b3-4a07-a874-0ecb53153f20" CreationDateTime="2017-06-05T13:09:33.202-00:00" ODMVersion="1.3" xmlns:mdsol="http://www.mdsol.com/ns/odm/metadata" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.cdisc.org/ns/odm/v1.3">
   <ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
        <SubjectData SubjectKey="1">
            <SiteRef LocationOID="1" />
            <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
                <FormData FormOID="CHEM" FormRepeatKey="1">
                    <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                        <ItemData ItemOID="CHEM.DATECOLL" Value="2015-04-25T14:09:00" />
                    </ItemGroupData>
                </FormData>
            </StudyEventData>
        </SubjectData>
    </ClinicalData>
    <ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
        <SubjectData SubjectKey="2">
            <SiteRef LocationOID="1" />
            <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
                <FormData FormOID="CHEM" FormRepeatKey="1">
                    <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                        <ItemData ItemOID="CHEM.DATECOLL" Value="2015-04-13T16:34:00" />
                    </ItemGroupData>
                </FormData>
            </StudyEventData>
        </SubjectData>
    </ClinicalData>
    <ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
        <SubjectData SubjectKey="3">
            <SiteRef LocationOID="1" />
            <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
                <FormData FormOID="CHEM" FormRepeatKey="1">
                    <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                        <ItemData ItemOID="CHEM.DATECOLL" Value="2015-05-09T18:52:00" />
                    </ItemGroupData>
                </FormData>
            </StudyEventData>
        </SubjectData>
    </ClinicalData>
    ...
</ODM>

SubjectDatasetRequest

Clinical data in ODM format for the given study / environment for a single subject. Similar to StudyDatasetRequest, this data can be optionally filtered by a specific Form.

This is the equivalent of calling: https://{subdomain}.mdsol.com/studies/{project}({environment})/subjects/{ subjectkey }/datasets/{ regular|raw }?{options}

or, to filter the data by form: https://{subdomain}.mdsol.com/studies/{project}({environment})/subjects/{ subjectkey }/datasets/{ regular|raw }/{ formoid }?{options}

using Medidata.RWS.Core.Requests
using Medidata.RWS.Core.Requests.Datasets;

//Create a connection
var connection = new RwsConnection("innovate", "username", "password"); // authentication required

//Send the request / get a response
var response = connection.SendRequest(new SubjectDatasetRequest("Mediflex", "Prod", subject_key: "1", dataset_type: "regular")) as RWSResponse;

//Write the XML response to the console (see XML below)
Console.Write(response.RawXMLString());

<?xml version="1.0" encoding="utf-8"?>
<ODM FileType="Snapshot" FileOID="9035596c-f090-4030-860a-0ed27a4e3d03" CreationDateTime="2017-06-05T13:28:39.325-00:00" ODMVersion="1.3" xmlns:mdsol="http://www.mdsol.com/ns/odm/metadata" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.cdisc.org/ns/odm/v1.3">
<ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
    <SubjectData SubjectKey="1">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="CHEM" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                    <ItemData ItemOID="CHEM.DATECOLL" Value="2015-04-25T16:09:00" />
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
<ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
    <SubjectData SubjectKey="1">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="ABX" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="ABX_LOG_LINE">
                    <ItemData ItemOID="ABX.ABXDATE" Value="2017-04-25" />
                    <ItemData ItemOID="ABX.MODALITY" Value="2" />
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
<ClinicalData StudyOID="Mediflex(Prod)" MetaDataVersionOID="1">
    <SubjectData SubjectKey="1">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="BONEMARROW" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="BONEMARROW_LOG_LINE">
                    <ItemData ItemOID="BONEMARROW.VISITDAT" Value="2015-04-24" />
                    <ItemData ItemOID="BONEMARROW.CHEMSAMPLE" Value="1" />
                    <ItemData ItemOID="BONEMARROW.BMPB_COLLECT" Value="1" />
                                            ...
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
    ...
</ODM>

VersionDatasetRequest

Clinical data in ODM format for the given study / environment for a single RAVE study version for all subjects. Similar to StudyDatasetRequest, this data can be optionally filtered by a specific Form.

This is the equivalent of calling: https://{subdomain}.mdsol.com/studies/{project}({environment})/versions/{ version_id }/datasets/{ regular|raw }?{options}

or, to filter the data by form: https://{subdomain}.mdsol.com/studies/{project}({environment})/versions/{ version_id }/datasets/{ regular|raw }/{ formoid }?{options}

using Medidata.RWS.Core.Requests
using Medidata.RWS.Core.Requests.Datasets;

//Create a connection
var connection = new RwsConnection("innovate", "username", "password"); // authentication required

//Send the request / get a response
var response = connection.SendRequest(new VersionDatasetRequest(project_name: "Mediflex", environment_name: "Dev", version_oid: "999")) as RWSResponse;

//Write the XML response to the console (see XML below)
Console.Write(response.RawXMLString());

Note the **MetaDataVersionOID* value in the XML response.*

<?xml version="1.0" encoding="utf-8"?>
<ODM FileType="Snapshot" FileOID="9035596c-f090-4030-860a-0ed27a4e3d03" CreationDateTime="2017-06-05T13:28:39.325-00:00" ODMVersion="1.3" xmlns:mdsol="http://www.mdsol.com/ns/odm/metadata" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.cdisc.org/ns/odm/v1.3">
<ClinicalData StudyOID="Mediflex(Dev)" MetaDataVersionOID="999">
    <SubjectData SubjectKey="1">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="CHEM" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                    <ItemData ItemOID="CHEM.DATECOLL" Value="2015-04-25T16:09:00" />
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
<ClinicalData StudyOID="Mediflex(Dev)" MetaDataVersionOID="999">
   <SubjectData SubjectKey="2">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="CHEM" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                    <ItemData ItemOID="CHEM.DATECOLL" Value="2016-04-25T16:09:00" />
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
<ClinicalData StudyOID="Mediflex(Dev)" MetaDataVersionOID="999">
    <SubjectData SubjectKey="3">
        <SiteRef LocationOID="1" />
        <StudyEventData StudyEventOID="SCREENING" StudyEventRepeatKey="1">
            <FormData FormOID="CHEM" FormRepeatKey="1">
                <ItemGroupData ItemGroupOID="CHEM_LOG_LINE">
                    <ItemData ItemOID="CHEM.DATECOLL" Value="2017-04-25T16:09:00" />
                </ItemGroupData>
            </FormData>
        </StudyEventData>
    </SubjectData>
</ClinicalData>
    ...
</ODM>