Argus Screen Shots General Tab - Katalyst HLS

01/29/17Katalyst Healthcares & Life Sciences
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ARGUS Screen SHOTS
General 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 Report
Clinical Trial
Literature 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’ field
Select 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 type
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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 response
Pharmaceutical Company Medical Affairs
Local Drug Safety Center Scientific Operations
Sales 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:
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Pre-configured Studies
SPECIFIC FIELDS AND PROCEDURESSPECIFIC FIELDS AND PROCEDURES
01/29/17
Katalyst Healthcares & Life Sciences
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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 eachCentre 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
01/29/17
Katalyst Healthcares & Life Sciences
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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.
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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 Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.comKatalyst Healthcares & Life Sciences

Argus Screen Shots General Tab - Katalyst HLS

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