31 January 2011
EMA/224149/2009
Veterinary Medicines and Product Data Management
EVVet - Frequently asked questions & common mistakes in data entry
Correct use of “Report Identification Number” and “Worldwide Case Number” 2
Primary Source Country 5
Primary Source section 6
Animal Data – “Exposed” and “Affected” numbers 7
Result in Death / Outcome death / Outcome killed 7
Use of VedDRA terms in Case reports 8
Animal Suspect Drugs 8
How do I enter multiple substance names for one product? 10
Use of the look-up tables 11
Same Adverse Event, multiple MAHs 12
How to save an unfinished case report and upload it in EVWEB at a later time 13
Best practice guidance on the generation of acknowledgment messages and follow up reports 19
How to create a follow-up for a case received in your Inbox 20
Correct use of “Report Identification Number” and “Worldwide Case Number”
The correct coding and use of the Report Identification Number (R.01) and the Worldwide Case Number (R.05) is extremely important, in particular to avoid creating duplicate reports.
The value for both fields should be a concatenation of the following three components, separated by a hyphen: Country code – Organisation ID - Case number
· The Country code is the country of the primary source of the report
· The Organisation ID is a unique abbreviation or code for the Sender Organisation, provided at the time of registration with EudraVigilance Veterinary by the Registration Team at the European Medicines Agency.
· The Case number is the Sender Organisation's case number for the report.
· Report Identification Number
This is the number given to a Case report by the current sender. If the initial Sender Organisation of a case report sends a follow-up of the case, this number may remain unchanged. However, if a different Sender Organisation sends a follow-up of this case, they should replace this number with their own “Report Identification Number”.
· Worldwide Case Number
This number is assigned to the Case report by the first Sender Organisation, and must remain unchanged in any subsequent retransmissions of the Case report, such as a follow-up, regardless whether the follow-up is made by the original sender or a different sender.
In conclusion, for the first electronic transmission of a Case Report, the “Report Identification Number” and the “Worldwide Case Number” (content and format) should be the same. When sending a follow-up, an organisation should give the case their own “Report Identification Number”, but not change the “Worldwide Case Number”. This field should always remain the same regardless of the number of follow-ups.
Example
A Case Report sent by a MAH to a Competent Authority (CA) concerning an adverse event occurred in France. The MAH has populated the “Report identification number” and the “Worldwide case number” fields as: 'FR-MAHID-12345'.
When the CA sends a follow-up of the case report, they should replace the “Report identification number” with their own value, i.e. “FR-FRCA-67890”. However, the value on the “Worldwide case number” field should remain as FR-DECOMPANY-12345'
Initial report from MAH - CORRECT
Follow up from CA- CORRECT
Follow up from CA - INCORRECT
Primary Source Country
The Primary Source Country (R.10) field should never be changed when sending a follow up report. Continuing with the same example:
Initial report - CORRECT
Follow up - INCORRECT
Primary Source section
The fields in the “Primary Source” section should never be changed when sending a follow-up Case report.
In some Case reports sent to EVVET, in the field “Primary Source Organization (R.28.12)” the name of the MAH that is currently reporting the Case to EV has been entered, instead of the organisation for which the Primary Source works.
INCORRECT entry showing MAH in Organisation field.
Animal Data – “Exposed” and “Affected” numbers
In some cases, it is preferable to express the data for the “Exposed” and “Affected” numbers (fields R.18.01 and R.18.02) as group instead of a single unit. E.g. for honey bees, the number of beehives should be reported instead of the number of singles bees. The fact that “number of beehives” and not “number of bees” have been reported should be stated in the “Case narrative”.
Result in Death / Outcome death / Outcome killed
When death occurs, all relevant fields (e.g. fields R.18.16.09 and R.18.16.11) should be filled in a consistent manner.
INCORRECT way to report death (inconsistent)
In many cases, “death” is mentioned in the narrative but is not then reported as a VedDRA Term in the “Animal signs” section where the “Reaction VedDRA terms (Code)” (R.18.16.21) are entered. For data analysis purposes, it is very important that the VedDRA term for “Death” is included in this field as shown in the following screenshot.
Use of VedDRA terms in Case reports
In some Case Reports, 7 or 8 clinical signs are mentioned in the case +narrative field, but only a few of those terms are then reported as VedDRA terms in field R.18.16.21. In many reports the term “Death” is also not coded as VedDRA (see bullet point above). A complete transcription of the clinical signs mentioned in the narrative text into VedDRA terms is of high importance, as most of the statistical analysis and signal detection is based on the VedDRA terms reported in this field. The “VedDRA terms” section is repeatable, to allow users to enter as many terms as necessary.
Animal Suspect Drugs
The correct filling of the Brand name (R.18.16.09) and Authorization Number (R.18.16.11) fields is of great importance for subsequent data analysis.
Substance names should not be entered in the “Brand name” field. EVVET has a dedicated section to report Substance names called “Animal suspect substances”.
The Authorisation Number should always be reported if known, as in most countries it unequivocally identifies the correct product / presentation.
Animal Suspect Drugs - CORRECT
Animal Suspect Drugs - INCORRECT
How do I enter multiple substance names for one product?
In case report related to product composed by 2 or more active substances, a commonly found error in EVVET is that, when entering Substances data, all active substances have been concatenated and reported as a single entry in the field “Substance Name (R. 18.17.32.03)”.
Each suspected substance should have one single entry.
The “Animal suspect substance” section is repeatable to allow users to enter as many substances as necessary.
Multiple Substance names - CORRECT
Substance name - INCORRECT
Use of the look-up tables
The available look-up tables and Product and Substance dictionaries are sometimes not used to their full potential. It has been noticed that in occasions some Product and Substance entries have been added using the “Text Edit” function, when very similar entries were already available in the Product / substance dictionary via the look-up function. These “Text” entries have to then be manually recoded to the relevant dictionary entries. It is therefore very important to avoid unnecessary work to use the existing look up entries before adding a “new entry”.
Same Adverse Event, multiple MAHs[1]
In cases where an animal has been administered several medicinal products concomitantly and an adverse event occurs, a situation might arise in which different MAHs send information related to the same adverse event to the relevant Competent Authority (CA). The CA has the key role of collating the information from all MAHs into one case report that will be forwarded to EVVet. Once all the information is collated into a single case report, the CA should inform all the involved MAHs of the Worldwide case number of this case report sent to EV, in order to avoid duplicates and to ensure that any subsequent follow-up is correctly numbered and identifiable as such.
How to save an unfinished case report and upload it in EVWEB at a later time
While entering data on an adverse event, you might wish to save a half-completed report and return to it at a later time.
To save the file, press XML on the toolbar
Then, click on “here” to open the XML version of the file
Next, click on “File”, “Save as”
You can then save the file on any folder in your computer by giving it a name of your choice:
To upload the file in EVWEB for further processing, open EVWEB, go to “Webtrader”, and click on “Local Import”.
You will get the following screen. Click on “Browse”. This will take you to your computer file system. Find the file that you have previously saved, and click on “Upload file”.
The following message will appear on the screen. Press “OK”.
You will then see the message below. Do not click on “OK” as this functionality only takes you to the “XML” version of the message, without uploading. Click on “Cancel”, and the attachement will then be uploaded in EVWEB.
Open the “tree view” (on the left hand side of the screen) by clicking on the “+” signs next to “ADR message” and “Safety reports”, and click on the report number so that it turns blue.
You will see that the toolbar changes, and the button “Edit” appears on the screen.
Click on “Edit”.
The SAR report will then be transferred to the “Send ADRs” section, where you can fill in the necessary details such as the Message number and Message receiver.
To fill in the message number, click on Message at the top of the left hand side of the screen. Then, on the box next to “Message number” on the right hand side of the screen, press “enter”, type a message number, and press “enter”
Then click on “Message receivers”. Double-click on either “EMEA”, “Pharmaceutical Company” or “Regulatory Authority”, depending on who your intended receiver is.
Tick the box next to your intended receiver. Before sending your message, it is advisable to press the “Validate” button, to confirm that there are no errors in your message.
After validation, press “Send”. The message will then be sent to your chosen receiver(s).
Best practice guidance on the generation of acknowledgment messages and follow up reports
· Acknowledgement messages:
Any organisation, being a MAH or CA, which has received an electronic ADR message should always send an acknowledgement message to the Sender Organisation as soon as possible. For EVWEB users, a quick semi-automatic way of generating acknowledgement messages from the Webtrader section was developed to facilitate this process. A guidance document on the use of the Webtrader can be found here.
· Follow-up reports
To avoid the unnecessary re-transmission of already known information, and the subsequent need to scan reports to identify any potential change in reported data, it was agreed at JIG that both CAs and MAHs should not routinely send follow-up reports unless additional information on the case has been received, or the causality assessment of the current assessor differs from the causality assessment assigned by the original reporting organisation.
How to create a follow-up for a case received in your Inbox
Go to “Web Trader”, “Inbox”, “Show Unprocessed Msgs”, then click on “Get New Messages” to refresh the unprocessed messages inbox. For cases you have already been dealing with, go to “Show In-process messages” or “Find processed Msgs”, depending on where you have manually archived the case you wish to “follow-up”.
Once you have the results of the query on the right hand side of the screen, click on the message that you want to follow-up, so that it turns blue, and press “Remote Import” to load it.
The file will then be uploaded. Open the “tree view” (on the left hand side of the screen) by clicking on the “+” signs next to “ADR message” and “Safety reports”, and click on the case number so that it becomes blue. You will see that the toolbar changes, and the button “Edit” appears on the screen.
Click on “Edit”.
The SAR report will then be transferred automatically to the “Send ADRs” section, where you can edit the information provided by filling in further details, and/or add your causality assessment. After validation, the ADR can then be sent to the EV system and to other users if required following the usual procedures.
Please note that when making a follow-up to a case, you should never change the original “Worldwide case number (R.05)”. However, you should change the “Report identification number (R.01)” to your own organisation number.
Further to a discussion on the JIG meeting on xxxx, it has been decided that the CA need to send a follow-up to a MA
EVVet - Frequently asked questions & common mistakes in data entryEMA/224149/2009 / Page 19/20
[1] Agreed at VetJIG meeting 21 October 2009