About access and filters

To properly view corresponding data in the Subject Data Analysis dashboard, you must have access to the Subject Form Items dataset. For more information see Permissions to access Oracle Clinical One Analytics datasets.

You can use a chart as a filter, too. Click the Filter icon () to the left of the visualization title. Click on any element of the chart with filter interactivity to filter out the remaining visualizations according to the selected data. To reverse the selection on the chart, click on any white space within the chart or use the Undo button () in the upper right corner of the browser window.

Note:

If the selected filters point to data not present on another chart, it displays a message that states No Data Found .

Reports

Individual Subject Data

Use cases

• A CRA who is interested in the data and finding the data in a study without difficulty.
• A physician who is overseeing the clinical study and wants to see whether the united individual subject information gets to another level.

Insights

• Get a centralized synopsis and particulars of an individual subject at a study and site level.
• Identify key data such as ethnicity, age, gender as part of a subject's demography.
• Review the visit schedule to help you monitor the progress of subjects in a clinical study or at a site.
• Review medical history, record, and physical examination parameters that are very important to relate a subject's condition to faster medical conclusions.
• Get access crucial information for sound decision making, such as a subject's vital signs.

Visualizations

Title	Description	Interactivity
Study Information (Listing Table)	Type: Table chart Columns: STUDY_TITLE STUDY_PHASE THERAPEUTIC_AREA BLINDING_TYPE STUDY_VERSION	Filtered data.
Site Information (Listing Table)	Type: Table chart Columns: SITE_ID_NAME SITE_NAME SITE_STATUS SITE_STUDY_VERSION SDV_GROUP_NAME ADDRESS_COUNTRY ADDRESS_CITY TIMEZONE	Filtered data.
Subject Details (Listing Table)	Type: Table chart Columns: SUBJECT_NUMBER STATE Total Visits Completed Visits Total Forms Completed Forms	Filtered data.
Subject Information (Listing Table)	Type: Table chart Columns: SUBJECT_NUMBER Gender Race Date of Birth Age Date of Informed Consent	Filtered data.
Visit Schedule (Listing Table)	Type: Timeline chart X-axis: VISIT_START_DATE Y-axis: EVENT_TITLE	Filtered data.
Medical History (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name Item Label Value	Filtered data.
Medical History Records (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name # (serial number) Condition Ongoing? Start date Resolved date	Filtered data.
Physical Examination (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name # (serial number) Body system Evaluation	Filtered data.
Vital Sign Detailed Report (Listing Table)	Type: Table chart Columns: SITE_NAME Visit Seq. Visit Name Weight Pulse Respiratory rate Temperature Unit Systolic Diastolic	Filtered data.
Vital Signs	Type: Line chart X-axis: EVENT_TITLE. Y-axis: Vital signs. All represented with a different color.	Filtered data.

AE (Adverse Event) & CM (Concomitant Medication) Data

Use cases

• Physicians, medical reviewers, data monitors, and biostatisticians are engaged in analyzing safety data from clinical studies. They typically want to speed up the analysis of a subject's medical narrative when they experience a serious adverse event and they're on medication during the clinical study.

Insights

• Identify if a subject has experienced an adverse event, its seriousness, and the duration of that event, as well as any other relevant details.
• Identify whether a subject is on any concomitant medication and for how long they've been on a specific medication.
• Cross-checking data related to a subject's adverse events, their occurences and the prescribed medication. This helps identify the efficacy of the investigational product.

Visualizations

Title	Description	Interactivity
Adverse Events (Listing Table)	Type: Table chart Columns: # (serial number) Adverse Event Severity Start date Ongoing? End date Any related medication? Serious Outcome PT SOC	Filtered data.
Prior and Concomitant Medications (Listing Table)	Type: Table chart Columns: # (serial number) Start date Stop date Route Ongoing? Medication name Indication Frequency Form Dose Dose unit ATC 1 ATC 4	Filtered data.
Adverse Events	Type: Scatter chart Y-axis: Event Term, AE# X-axis: AE Days	Filtered data.
Prior and Concomitant Medications	Type: Scatter chart Y-axis: Medication Name, CM# X-axis: CM Days	Filtered data.

Lab Data

Use cases

• Physicians, medical reviewers, and data monitors need to identify a subject's medical conditions and monitor the progression and efficacy of a treatment. This custom report can help us diagnose, monitor, screen, and research a subject's medical condition.

Insights

• Identify signs or parameters of a subject's biochemistry, hematology, cardiac biomarkers, and more.
• Track the efficacy or progression of a subject's treatment.

Visualizations

Title	Description	Interactivity
Cardiac Biomarkers (Central Labs) (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name # (serial number) Lab Test Lab Result Lab Unit High Range Low Range	Filtered data.
Biochemistry (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name # (serial number) Lab Test Lab Result Lab Unit High Range Low Range	Filtered data.
Hematology (Listing Table)	Type: Table chart Columns: Visit Seq. Visit Name # (serial number) Lab Test Lab Result Lab Unit High Range Low Range	Filtered data.
Cardiac Biomarkers (Central Labs)	Type: Stacked category chart X-axis: EVENT_TITLE with different columns for each lab test number and name. Y-axis: High Range, Low Range, Lab Result represented with different colors.	Filtered data.
Biochemistry	Type: Stacked category chart X-axis: EVENT_TITLE with different columns for each lab test number and name. Y-axis: High Range, Low Range, Lab Result represented with different colors.	Filtered data.
Hematology	Type: Stacked category chart X-axis: EVENT_TITLE with different columns for each lab test number and name. Y-axis: High Range, Low Range, Lab Result represented with different colors.	Filtered data.