Argus Patient Screen Tab Training - Katalyst HLS

ARGUSPATIENT SCREEN

05/02/23Katalyst Healthcares & Life

Sciences

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Patient Information:For SR & LIT cases Enter initials only Protect Confidentiality box not checked

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Katalyst Healthcares & Life Sciences

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Patient Information

For PMS cases Enter initials only Enter patient ID if reported Protect Confidentiality box not checked

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Patient Information (cont)Patient Information (cont)

Enter date of birth. If incomplete type in hyphen for missing information. eg ‘-’ ‘-’ 1994

Patient age: Age and age group will only be calculated automatically if the date of birth and a full event onset date are entered.

If partial onset date has been entered enter the age and age group manually.

Ethnicity: SR - To be entered as locally requiredCT - Entered if information provided

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Other Relevant History:Other Relevant History:

Enter relevant medical history including current medical conditions.

As a general rule, indications of suspect drugs should not be entered as relevant history. However there are exceptions where the condition has happened more than once eg. Transplant.

The indications of co-medications should be entered and coded in the relevant medical history field as they highlight the current condition of the patient.

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Other Relevant History (Cont)Other Relevant History (Cont)

The following ‘Condition Type’ are used by Novartis:

- Current Condition- Historical Condition- Historical Drug- Drug Reaction History- Family History

Leave blank if unknown

Repeat ‘Description’ verbatim term in the Notes field if the Preferred Term is not specific enough.

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Medical History Field

Historical drugs can be represented in the medical history field if required.

Select ‘Historical Drug’ as condition type. The drug name can then be coded against the

WHO dictionary. The Indication for the ‘Historical Drug’ can be

entered as well as the reaction if known

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‘Historical Drugs’ Condition type

When to Use:

This condition should be used only in the following situations:

Historical drugs that have been highlighted by the reporter as medically relevant to the patient’s status.

Specific historical drugs/therapies highlighted by the Novartis medical safety physician as medically relevant and requiring routine screening.

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Definition of a historical drug: The decision as to whether a medication is

historical or not should be based on the following: If unlikely that the product is still in the body system and there

are no biological effects known or suspected in the patient, enter as a ‘Historical Drug’ in the Other Relevant History.

If the drug is still in the body system and there is a suggestion of biological activity (even if the kinetics suggest complete elimination), the product should be entered as a co-medication in the Product tab

If in doubt, consult the PVL.

‘Historical Drugs’ Condition type

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Other Relevant History (Cont)Other Relevant History (Cont)

To enter more patient history data click on the Add button To delete a history record, click on the Delete button Ongoing checkbox: Not used by Novartis

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Laboratory Data:

Relevant tests such as laboratory data, scans, tests and examinations should be captured in the coded field for E2b submissions and also as free texts in the free text Relevant Tests field

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Coded Lab Data Field:

Only enter test results that are relevant to the events being reported. The coded field should summarise the essential test results and should only include tests which:

Show abnormalities outside of the normal range relevant to the events being reported.

Disprove a diagnosis or suspected underlying cause for the event Support or confirm a diagnosis Show trends, e.g. increasing white blood cell count during an infection. Always

include a baseline value if provided followed by the peak and resolution values Show a normalisation of previously abnormal test results

Do not include tests which: Show abnormal values that are normal/baseline in the specific patient population

under study. Are not relevant to the events being reported.

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Type in the test name as reported and click on ‚Encode‘

Click on units field and select theappropriate units if reported

Enter the Normal range if reported

To enter a test result and click on ‚Add test‘

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Click on ‚Add Date‘

Enter the date and clickon the orange triangleand click on Add

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Enter the result and selectNormal, High or low from the drop down list

The Notes field can also be used to display results for investigationswhich do not have numerical values e.g. ECG and biopsy results.

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Relevant Test Field:

In the event that a test can not be coded or captured appropriately in the coded text field, it can be entered as free text in the relevant test field.

Enter date or relevant time point of test in brackets, e.g. (14 Mar 2007) or (10 days post transplant) or (Date unknown)

Enter test specification followed by test result, e.g. Haemoglobin 9.4 Enter test units if reported, e.g. Haemoglobin 9.4 g/dL If the same test is repeated over a number of days, a normal range should

only be entered next to the first entry as shown in the example. Group similar laboratory tests. Abbreviations can be used if the test is fully

defined for the first result or in the case narrative. Enter repeated tests in date order so that any trend over time can be clearly

seen Example:

(Date unknown) AST 20 U/L (normal range 15-30)(Date unknown) AST 150 U/L(Date unknown) AST 40 U/L

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Thank YouThank You&&

QuestionsQuestions

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Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]

mailto:[email protected]

Date post:	20-Mar-2017
Category:	Health & Medicine
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Argus Patient Screen Tab Training - Katalyst HLS

Health & Medicine