Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page 4 of 7

[¥® Case search result
Number of Cases Matching Search 416

Mack All

Diag 2 column header here to group by that cokumn

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= 01 2-U' A C at 7 5 L

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|_O [ami2usa..|23Sep20../us Howl, pant. a
| 15xlun-2006 | US ‘Animal Co... [Dog | took my a
| O1Jun-2006| US ‘Animal Co... [Dog Pet was br. q
| 25-Aug-20... US Animal Co... [Dog The owner L
| 20Mar-20... |US ‘Animal Co... [Cat Balinese [Severe Se a
| 30-Sep-20... |US Animal Co... [Cat Siamese [haven't init IL
[S por2us9.|15Nov20..|US ‘Avimal Co... Cat vestibular r L
| [am2us0..[230e020../us [Animal Co... [Dog Pug diphenhyd. "
| 2012:US-0...|28-Dec-20..|US Animal Co... [Dog [facial swell IL
|o 2012:US-0...| 30an-2006| US Arimal Co... [Dog Chihuahua Immediate IL
[0 J2mi2us.0../08Mer20... [US ‘Avimal Co... [Dog [NZ a
| fami2uso..[21-Mer20..[us ‘Animal Co... |Dog Petocular a
|  [ami2us..[14Mar20...[us ‘Avimal Co... [Dog [facial swe t
| [aoraus...|14Feb20.. [Us ‘Animal Co... [Dog {small bum t
| [ani2us.o..|14Mer20.. [us ‘Animal Co... [Dog Pet began IL ica

Rep Jz ic | Fir, | Updote | Browse | Cancel | He |

The first column of this list defines the cases that will be reported. By default no cases are
selected, leaving the user with the option to include all selected cases or some of them in the

report. Selected rows are indicated with a check mark ca

To select all of the cases in the list, click the Mark All button Maka | . Note that after
clicking this button every row will have a check mark in the first column. This global
selection can be reversed by clicking the Unmark All button which appears after the Mark All
button has been used.

Alternatively, click the box in each row of the case(s) that should be reported. It is possible to
use both techniques together, e.g., Mark All and then uncheck some cases.

Once all cases to be reported have been checked, generate the report.

2. Create Report

Repor
Click on the <Report> button

Choose Crystal Reports — External Case Summary Reports

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page 7 of 7

@/|@|@

Word Exp CSV [Exp XLS

External Case Summary Report

Information Systems

(pRopucts

Suspect product #1 details
8 rand description:

Manufacturer:
MAH Holder: TT MAH Refs:

Time to onset last dose (text):
Was product used correctly: Unknown to Company Misuse type:

Has patient had this product before: When details: N/A
Has patient reacted to this product before: When details: N/A
Reason for use: LOE reason: N/A
Attending veterinarian's level of suspicion:

Suspect product #1, dose #1 details

Route:
Administered by:
End datefongoing:
Duration/duration text:
Time to onset from start date: Time to onset from end date:
Dose: Frequency:
Dose text:

Suspect product #1, dose #1, batch #1 details

Product lot LOT-1234 Lotexpiry date: 01-Mar-2008
Product Serial: Serial expiry date:

Oluent Seriat: Diluent expiry date:

Suspect product #1, dose #1, batch #2 details

Product lot LOT-1234 Lotexpirydate: 01-Mar-2008 Subreport:PRO
Product Serial: Serial expiry date: —
Dituent Seria: Diluent expiry date:

No concomitant products

(Patients

Click the PDF button to save this report as a PDF file.

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page 3 of 7

Query | G Predefined Queries My Queries Dente |
Dose text =] operation Value(s)
Enterprise category 1
Enterprise category 2 product -MA holder
Envronment

Expry date ot / batch) Jearor SO

Expry date (product serial)
Expiry date (product divent)
Formulaton

Frequency

Has patient had before?
Details of previous use

Has patient reacted before?
Details of previous reaction
Has vet seen similar reaction
Details of vet seeing before

fii holder
15 AF

MA reference
Manufacturer

Tas patent reacted before? A RIE
eta of previous reacton

Has vt seen sma reacton
Detas of vet seeing before

MA country E |

MA holder

0

MA reference

Product -MA reference

Manufacturer
Manufactured in

Master manufacturing batch
Per

Per unit

@ Predefined Queries ~ My Queries |
|

Show Matches

Click the Show Matches button to display a list of selected cases.

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System

Release Date: 05 Sep 2019

Select Report

Author: WHULS

Document Number: CVB-WI-0127.02

Page 5 of 7

Internal Reports Regulatory Reports
EI Crystal Reports a] Australian Veterinary Report

AE Rate Top n CFIA
AE Report Rate by Product/Spec CVMP Report
AUDITADMIN FDA 1932
Animals by product with patients FDA 1932 v2010
Cases received by country FIFRA Incident Report
Cases received by product South African Report
Cases received by state UK Poultry Report
Clinical signs by product USDA Report

Human exposures by product
Lack of efficacy by product

Product defects by product
QA incidence report

S|

Pharmacovigilance incidence rep

XML Case Export

Run

Run report by clicking the run button. This will display a report parameter screen.

In the parameter screen — select ‘Last Find Case Query’ from the drop down list “run in
single case or PSUR Mode”. Optionally you can determine whether or not assessment
information and reporter details should be included in each case summary. To include these,
check the appropriate optional boxes. For FOIA requests both of these should be checked; the
FOIA office will redact as necessary.

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.

For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Nb

Veterinary Services

CVB Inspection and Compliance Procedure for Generating Case
Summaries from PvWorks System

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-WI-0127 Revision: 02

Previous Number: ICWI0128.01

Author: WHULS
Section/Area: CVB-WI-IC
Release Date: 05 Sep 2019
Notes:

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page 6 of 7

Assured Information Systems Ltd
External Case Summary Report

hoose Single Case, Find Case or PSUR mode, If using PSUR mode then
select a PSUR Id from the list below.

Run in Single case or PSUR Mode: [see eo =

Or Select a PSUR Id: +

Indude Assessment Information: [|

Show reporter details: al

Click the run button to create the report. This will be displayed on the screen. Note that the
execution time may be considerable if many cases are included.

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page | of 7

CVB Inspection and Compliance Procedure for Generating Case Summaries from PV
Works System

Background: The purpose of this work instruction is to generate a PDF summary report of
selected cases. This report may be used in response to FOIA requests as well as for other
purposes.

This is a two-step process:

1) Select cases to be reported
2) Create report

1. Select cases to be reported
To run the batch printing report, first find the cases you want to print.
To do this, use the ‘Find Cases’ functionality in the top left hand corner of the Grid (i.e., via

the find binoculars button | SBF |),

Fd PV-Works (Vet) Proof of Concept

File Data ep Ta: External Help

aw [AY update E coding - 3 Reports (- *
14 4pus {$0000 ¥

then select the ‘Build a Query option’ from the submenu;

FAY PV-Works (Vet) Proof of Concept

File Data Report Tasks External Help

& | New (4 Update € Coding ~ el Reports | =} |
Es us ooos ¥

VedDRA preferred term

Cases by date received
rrr

[=]

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only


Title: CVB Inspection and Compliance Procedure for Generating Case Summaries from PvWorks System
Release Date: 05 Sep 2019 Author: WHULS Document Number: CVB-WI-0127.02

Page 2 of 7

Build a Query

y  @ Predefined Queries ©) My Queries

oa Value(s)

4 Case Identification
Case owner
Case responsible
Case type
Country of occurrence
Date first received
Date first vad
Date of latest folow up
Information type
PV Reference number
Internal case number

<4-COPR - Issue Payment
‘Account number
‘Amount
‘Amount currency
‘Cheque number
Date requested
Payable by
‘Send to last name
Other

Selected product brand
Selected product generic
‘Send to last name
‘Shipping order tracking number
Other

4-Company Assessment
‘Assessment record exists
Causality assessment

Save Query.

Enter your Query details. For example: all cases received from | January 2004 to present for
HE abies product EEE This requires three query elements as follows:

Query | TZ] @ Predefined Queries (~ My Queries _Dalete|
TB calistory =] operation Value(s)
3 Other
[Case Identification Case Identification - Date first received
Case onner
Case responstle = =] | [i Ban [ove a3]
‘Case type

‘Country of occurrence

Date first vaid
Date of latest follow up
Information tvoe

CVB-WI-0127.02

Printed by: CRRYAN on 09 Sep 2019, 08:16:18 am.
For Official Use Only