argus screen shots general tab - katalyst hls

05/02/23

Katalyst Healthcares & Life Sciences

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ARGUS Screen SHOTSGeneral Tab

GENERAL SCREENGENERAL SCREEN

Entering

‘General information’ ‘Study information’ ‘Reporter information’ ‘Literature information’

into ARGUS SAFETY

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GENERAL SCREENGENERAL SCREEN

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GENERAL INFORMATION

Report type:Spontaneous ReportClinical TrialLiterature Case

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Reporter Type

Indicates source of report.

Only one report type per case.

Used by ARGUS Safety workflow, expediting and PSUR generation.

Case report type can change based on follow-up information

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GENERAL INFORMATION

Data already entered during book-in: Country of incidence Initial receipt date Central receipt date

Other fields: Case Status (shows work flow status) Fields referring to FU information (see chapter

on FU)

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GENERAL INFORMATION

Case Category: Important in searching Some case categories can only be used with

certain report types (validation check) Assists in filtering cases

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CASE CATEGORY

Spontaneous Report: Device spontaneous

report

Clinical Trial: Clinical trial Compassionate Use Device trial Epidemiological study Intensive monitoring project Non-Novartis trial Novartis patient registry Non-Novartis patient

registry Other studies Post Marketing Surveillance Protocol exempted SAE

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CASE CATEGORY

Other case categories: Beneficial effect unexpected Deactivated Case Deactivated Case – other MAH Lactation related Legal case Multiple patient case (used for legacy cases) Pregnancy prospectively received Pregnancy retrospectively received Pregnancy no AE Fwd to Tech OP

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Reporter Information:

Reporter name and address must be collected if possible.

Indicate in the narrative if the report is from a consumer, physician, health authority or other company.

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Missing reporter last name: Do not leave ‘Last Name’ field empty but enter ‘Not available’

or ‘Anonymous’

The “Protect Confidentiality” checkbox must be checked for such cases

This also applies to cases received from Health Authorities and other intermediary reporters, when the primary reporter’s name is not provided.

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Reporter Information

‘Health Care Professional’ fieldSelect YES if the report was received

from a health professional. from Health Authorities from scientific literature Qualifications of source are not identifiable

Select No if report was received from Consumer Lawyer/attorney Other company

Radio buttons are linked with ‘Reporter type05/02/23


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Reporter Information

Other reporter information fields: Reporter type (linked with HCP radio buttons and ‘Protect

confidentiality’ tick box) Intermediary e.g.

Regulatory Authority Customer responsePharmaceutical Company Medical AffairsLocal Drug Safety CenterScientific OperationsSales Representative Technical Operations

Report sent to Regulatory Authority by Reporter ?

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‘Protect Confidentiality’ tick box is checked for Consumer/patient reports or reports from relatives of

consumer/patient Case where intermediary does not provide initial

reporter’s name (anonymous reporter, HA reports, reports from other company)

For all German and French cases For all correspondence contacts “Name and address withheld” will be printed on

regulatory forms.

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Primary reporter/correspondence contact Primary Reporter is the ACTUAL REPORTER e.g. patient,

physician, pharmacist, etc. Primary Reporter will be printed on regulatory forms. A Primary Reporter can also be the Correspondence Contact. Correspondence Contacts not marked as Primary Reporter

can be the patient’s physician name and address when provided by

patient Health Authority, License partner or other intermediary correspondence address in literature reports.

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Guidance on primary in consumer cases was added:

AE is initially reported by a consumer, the consumer is entered as primary reporter.

When the case is later confirmed by a Healthcare Professional, the HP becomes the ‘Primary reporter’ and correspondence contact.

If the opposite occurs ie additional information is provided by the consumer after an initial report has been submitted by a HP, the HP remains the ‘Primary reporter’ and the correspondence contact.


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Specific scenarios

Consumer is health professional

Enter similar to consumer reports

Select ‘Health Care Professional’ YES

Check ‘Protect Confidentiality’ box

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Specific scenarios… many more

please refer to MAP

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Literature Reports:

Entering the Literature Information

If you select ‘Literature’ as a report type the following screen will be displayed:

05/02/23Katalyst Healthcares & Life Sciences

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Pre-configured StudiesSPECIFIC FIELDS AND PROCEDURESSPECIFIC FIELDS AND PROCEDURES


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Pre-configured Study information

Protocol ID - Populated from book-inProtocol ID - Populated from book-in Study ID - Populated from book-inStudy ID - Populated from book-in Centre ID - Study site - centres are configured for each Centre ID - Study site - centres are configured for each

specific study and can be selected from a drop down box.specific study and can be selected from a drop down box. In the product screen, depending on the trial design, the

drug may have to be reselected from the administered drug field and the indication may have to be recoded.

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Case Categories:Case Categories:

In addition to adverse event related case categories, for PMS/Registry cases, you have to select a specific case category- Post Marketing Surveillance- Novartis Patient Registry- Non-Novartis Patient Registry- Intensive Monitoring Project

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License Partner And other Company Specifics


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License Partner Cases:

Enter the initial reporter as a primary reporter. If the reporter is a health care professional or not

specified, enter as a health care professional. If it has been stated that the reporter is not a HCP,

enter as appropriate eg. Consumer, lawyer or relative. Enter the license partner as a second tab and mark as

Correspondence Contact and tick Protect confidentiality

The licence partner must be selected using the ‘Select’ button.

If not configured, contact your local administrator.05/02/23


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Cases from other companies

Enter the initial reporter as a primary reporter

If the reporter is a health care professional or is not specified enter as a HCP.

If stated that the reporter is not a health care professional, enter as appropriate, eg. Consumer, lawyer or relative.

Enter the Pharmaceutical company as a second tab and mark as Correspondence Contact and tick Protect confidentiality.

Health Care Professional ‘No’ should be selected for the other company

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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] Katalyst Healthcares & Life Sciences

mailto:[email protected]

argus screen shots general tab - katalyst hls

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