EVVet - Best practice guide - Pharmacovigilance



08/0105/20152018

EMA/224149/2009 "Error*"EMA/224149/2009 \* MERGEFORMAT EMA/224149/2009 – Rev.34

Veterinary Medicines and Product Data Management

EVVet – Best practice guide

Contents

Introduction 2

1. Administrative data 3

1.1 Correct use of “Report Identification Number” and “Worldwide Case Number” 3

1.2 Primary Source information 6

2. Scientific data 7

2.1 Species and breeds 7

2.2 Animal Data – “Exposed” and “Affected” numbers 7

2.3 Splitting reports 8

2.3 Result in Death? / Outcome died / Outcome killed 9

2.4 Use of VedDRA terms in AE reports 11

2.5 Animal Suspect Drugs 12

2.6 How do I enter multiple substance names for one product? 14

2.7 Use of the look-up tables 16

2.8 For NCAs: Same Adverse Event, multiple MAHs 16

2.9 For MAHs: Best practice guidance on causality assessment 16

2.10 Reporting requirements in relation to clinical and marketing trials 17

3. How to avoid sending duplicate reports and how to deal with duplicates sent to EVVET 18

4. Guidance on the use of the Web trader: generation of acknowledgment messages and follow up reports 19

4.2 21

4.3 How to process a report received in your Inbox 21

Managing your Inbox 24

4.4 Best practice on acknowledgement management and generation of follow-up reports 28

5. How to save an unfinished AE report and upload it in EVWEB at a later time 29

6. How to nullify an AE report sent by mistake to EVVET 35

Introduction 3

1. Administrative data 4

1.1 Correct use of “Report Identification Number” and “Worldwide Case Number” 4

1.2 Primary Source information 7

2. Scientific data 8

2.1 Species and breeds 8

2.2 Animal Data – “Exposed” and “Affected” numbers 8

2.3 Result in Death? / Outcome died / Outcome killed 10

2.4 Use of VedDRA terms in AE reports 12

2.5 Animal Suspect Drugs 13

2.6 How do I enter multiple substance names for one product? 15

2.7 Use of the look-up tables 16

2.8 For NCAs: Same Adverse Event, multiple MAHs 16

2.9 For MAHs: Best practice guidance on causality assessment 16

2.10 Reporting requirements in relation to clinical and marketing trials 17

3. How to avoid sending duplicate reports and how to deal with duplicates sent to EVVET 18

4. Guidance on the use of the Web trader: generation of acknowledgment messages and follow up reports 18

4.1 How to create an acknowledgement for a message received in your Inbox 21

4.2 Processing messages received in your Inbox 23

4.3 How to create a follow-up for a case received in your Inbox 27

4.4 Best practice on generation of acknowledgements and follow-up reports 28

5. How to save an unfinished AE report and upload it in EVWEB at a later time 29

6. How to nullify an AE report sent by mistake to EVVET 35

Introduction

This document targets all organisations that send adverse event reports via the Eudravigilance Veterinary network (EVVET).

When sending reports via Eudravigilance, it is important to precisely complete as many of the fields as possible. While the goal of this document is not to provide a detailed description of each of the fields to be filled out in Eudravigilance, it will emphasise certain fields or sections which are particularly important for the administrative and scientific processing of these reports, and/or for which experience has revealed divergent interpretations in the way to fill them out.

These recommendations apply to both administrative and scientific data.

1. Administrative data

1.1 Correct use of “Report Identification Number” and “Worldwide Case Number”

The correct coding and use of the Sender Report Identification Number (R.01) and the Worldwide Case Number (R.05) is extremely important in order to avoid creating duplicate reports.

The value for these fields should follow this format: Country code – Organisation ID – Internal case reference code

• The Country code is the country of the primary source of the report. Please note that some MAH have already adopted the 3 letter country code convention as per VICH guidance.

• The Organisation ID is a unique abbreviation or code for the Sender Organisation provided at the time of registration with EVVET.

• The Internal case reference code is the number given to the case by the organisation sending the report.

|Data |Recommendations |

|Message number |It is a mandatory field, with “free” format. Each organisation can choose whether to implement their own |

| |internal convention for this number to make easier to trace particular messages. As the message number acts as |

| |the identifier of the current transmission, when sending a follow-up, a new message number should be used. |

|Information type |This field is to chooseselect what kind of report you are sending. Choose lack of expected efficacy for reports|

| |with no safety aspects. Do not code in VedDRA the only if there are no disease symptoms and no coded signs. For|

| |reports with both safety and lack of expected efficacy aspects, select “Safety issue”, code the adverse event |

| |signs as VedDRA terms, and use the VedDRA term “Lack of efficacy”. |

|Sender report identification |Number given to an AE report by the organisation sending the case, constructed following the format described |

|number |above. If the initial sender organisation of an AE report sends a follow-up this number may remain unchanged. |

| |However, if a different Sender Organisation sends a follow-up to this AE report, they should replace this |

| |number with their own “Report Identification Number |

|Worldwide case number |This number is assigned to the AE report by the first Sender Organisation, and must never be changed in any |

| |subsequent retransmissions of the AE report, such as a follow-up, regardless whether the follow-up is made by |

| |the original sender or by a different sen der. The number should follow the format described above. |

| |In order to avoid creating duplicates, please provide the original worldwide number when sending follow-ups. |

|Original received date |To be filled in and remain unchanged when sending in additional information. |

| |This is the date of first communication of an AER from the primary reporter to the MAH or RA. This date is |

| |fixed and cannot be changed in future submissions. |

|Most recent info date |To be filled in systematically and updated when sending additional information, including when an assessor adds|

| |their own assessment to a case initially sent by another organisation. This field needs to be filled with the |

| |date whenle latest information was received and when use correctly enables rapid identification of case |

| |follow-ups. For best practice guidance on when to send follow-ups please click here. |

| | |

| |In instances where the “most recent info date” may cause potential confusion, or if there are discrepancies in |

| |dates, the reasons should be explained in the “Case narrative” field. For example, when further information |

| |received results in a change from “non-serious” to “serious” classification of a report, the “Most recent info |

| |date” may give the impression that the report may not have been submitted within the expedited time-frame. |

Examples are shown on the following pages for further clarification

Example

An AE report has been sent by a MAH to the French 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-DECOMPANY-12345'.

When the CA forwards this case to EVVET, they should replace the “Report identification number” with their own value, i.e. “FR-FRCA-67890”, but the value on the “Worldwide case number” field should stay as “FR-DECOMPANY-12345”

Initial report from MAH - CORRECT

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Follow up from CA- CORRECT

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Follow up from CA – INCORRECT

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1.2 Primary Source information

To facilitate the identification of duplicates, while maintaining anonymity of the Primary Source in accordance with data protection legislation, it has been agreed at JIG that the information of the primary source could be replaced by “withheld” or by entering only the initials of the First Name and Last Name. However, it is still advised to include the geographical information (e.g. the first two characters of the post code).

The information entered in the fields in the “Primary Source” section should never be changed when sending a follow-up report.

Primary source information - CORRECT

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2. Scientific data

2.1 Species and breeds

In many AE reports sent to EVVET, where the species mentioned in the case narrative is clearly a species that exists in the “Standard list”, e.g “Canine/dog”, but the breed is either unknown or does not exist in the standard list currently implemented in EVVET, some organisations have used the species code “Other canidae” with the breed code “Other canidae NOS”. 

The term “Other canidae” (and the equivalent terms for other species) has been included in the “Species and Breeds list” to code cases where the reported “Species” is not one of the species already included in the list, and not to code “unknown” breeds.

The correct practice in these cases (using “dog” as an example) should be to use the “species code” “CANDO” “Canine/dog”, and either leave the “breed” field blank if the breed is “unknown”, as the field is not mandatory, or if the breed is “known” but the breed name is not included in the EVVET list, use the breed code “Cando169” “Other Canine/dog”.

If there is a very rare species and it’s not in the list, it is possible to enter the text manually in the field “Species (Text)”.

2.2 Animal Data – “Exposed” and “Affected” numbers

|Affected animal or |Enter the number of individuals treated and affected. |

|human |If the number of exposed individuals is not known, the number of affected individuals should be provided by default. |

| |If both are unknown, provide an approximation. |

| |Please note that in case fatalities are reported, the number of dead animals should also be populated accordingly on the|

| |relevant fields on the “Animal adverse reaction” section. |

| |Send one report per species. |

| |Fill in the age, sex and weight data. This may affect case assessment and can be used for determining whether use was |

| |compliant with the MA. |

| |Regarding the age, it’s important to keep the same age unit even if the animals’s ages vary greatly. s are more than |

| |one. |

| |For groups of animals: provide an age and weight range and for the sex fill in "mixed" for the sex if both males and |

| |females are involved. |

| |This data may affect case assessment and can be used for determining whether use was compliant with the MA. |

| |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 a 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”. |

| |Effects on offspring: fill in offspring information (age, weight, sex, number of exposed and affected individuals and |

| |outcome) and specify in the text whether the mother or father received treatment. |

| | |

2.3 Splitting reports

A report received from a veterinarian concerning e.g. multiple animals in the same farm/household that have received different products, with different dates of administration and with different time to onset of adverse events should be split and sent as separate reports.

When splitting reports, it is very important that the “linked report” field is filled in with the world-wide case number(s) of the connected reports. It is also advised that this information and the rationale for splitting are added to the narratives of the separate reports.

However, Ssplitting reports should be exceptional and limited as much as possible,possible; ,even e.g. reports with the in the following scenarios should not be split:

- Reports with Eadverse events classified as serious and non-serious in the same case that involves multiple animals,

- Un-connected AE in the same animal in the same case (e.g. local skin reaction and blindness)

- Multiple animals in the same case e.g with different time to onset .

Information on VedDRA terms related to a single animal should only be included in one report and never be split. Outcome information e.g.shuch as death, shall also only be submitted in one report.

e.g. in the same farm/household orof adverse events

Lastly, when splitting reports, it is very important that the “linked report” field is filled in with the world wide case number(s) of the connected “reports”. It is also advised that this information and the rational for the split are added to the narratives of the separate reports.

2.3 Result in Death? / Outcome died / Outcome killed

When reporting a death, all relevant fields (e.g. fields “Results in death?” R.18.16.09 and “Outcome died” R.18.16.17 or “Outcome killed” R.18.16.18) should be filled in a consistent manner.

Death should also be coded as a “VedDRA term” using the appropriate VeDDRA low level term (see also the guidance notes on the use of Veterinary Dictionary for Drug Related Affairs terminology for reporting suspected adverse reactions in animals and humans ).

In many AE reports, “death” has been mentioned in the case narrative but has not been reported as a VedDRA Term in the “Animal signs” section, where the “Reaction VedDRA terms” (R.18.16.21) are entered. For data analysis purposes, it is very important that the VedDRA term for “Death” is coded as shown in the following screenshots.

CORRECT way to report death of 1 animal

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When “delayed” death or Lack of efficacy occurs in products used for euthanasia the Veddra term “unrelated death” must be entered.

2.4 Use of VedDRA terms in AE reports

In some AE reports, 7 or 8 clinical signs may have been mentioned in the “case narrative” field, which describes the events with the terms used by the primary source, but only a few of those clinical terms have then been coded as “VedDRA terms” in the “Animal signs” section (R.18.16.21).

A complete transcription of the clinical signs mentioned in the narrative text into VedDRA terms is of high importance, even if some the terms that were used in the narrative are similar, as most of the statistical analysis and signal detection is based on the VedDRA terms reported in this section. The “Animal signs” section is repeatable, to allow users to enter as many terms as needed.

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2.5 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.

|Product(s) involved |Full name of the medicinal product (including dosage and dosage form). |

| |If the precise /full brand name of the medicinal product is not known, please enter as much information as you have |

| |available, e.g. “common name”. |

| |In some instances, when non-specific product information has been received from the primary source it might be possible|

| |to extrapolate the product information to a particular presentation by using other information from the case narrative.|

| |When extrapolation of the brand name has taken place it should be indicated in the case narrative. |

| |The Authorisation Number should always be reported if known, as in most countries it unequivocally identifies the |

| |correct product / presentation |

| |As the animal(s) might have been treated with more than one medicinal product, the product section is repeatable to |

| |allow users to enter data for as many medicinal products as necessary. In this case there is an option to classify the |

| |product as concomitant, interacting and suspect. This section is not mandatory, but if included, it shall be entered as|

| |provided by the original reporter and never be changed in any subsequent reports. Should this information be absent |

| |from the initial report, it should then never be completed. |

| |Precise dates of the beginning and end of treatment, consistent with the date of onset of the reaction (beginning of |

| |treatment must occur before onset of the reaction). |

| |The treatment and reaction dates make it possible to determine the period before symptom onset, which are essential |

| |assessment data. |

| |Route of administration, dose, treatment duration. |

| |These data also make it possible to determine whether or not use was compliant with the MA. |

| |For vaccines: the date treatment began must be the date of the last time the product was administrated before onset of |

| |the reaction. E.g.: if the animal reacted after a booster vaccination, and the vaccine was administered for the first |

| |time a year prior to this, you should indicate the date of the booster, not the date of the initial vaccination as the |

| |date when treatment began and then you could enter the full explainnation it in the case narrative.. |

| |Similarly, do not indicate "12 months" as the treatment duration. In this case, you do not need to provide treatment |

| |duration. Previous or later treatment dates should only be mentioned in the “Case Narrative" section. |

| |Batch number, expiration date. |

| |These data may be used to identify a possible quality flaw. |

A common but incorrect practice when the precise Brand name of the product is unknown is to report the “Active substance” name in the “Brand name” field. The correct practice is to leave the “Brand name” field blank and enter the “Active substance” name in the relevant field in “Animal suspect substance” section.

Animal Suspect Drugs - CORRECT

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Animal Suspect Drugs – INCORRECT

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2.6 How do I enter multiple substance names for one product?

In AE reports related to products composed by 2 or more active substances, these substances are often erroneously entered concatenated in the “Active substance” name field “Substance Name (R. 18.17.32.03)”, in some instances even including the strength.

In vaccines, it may be possible that the suspect substance is an adjuvant. In this case you can select “adjuvant” in the field role and then add it in the substance name. If it’s not in the list, you can press “E” and add itthe name manually.

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As the “Animal suspect substance” section is repeatable the correct procedure is to repeat the section for each active substance contained in the product.

The strength of the substance should be entered on the “Strengh” field.

Multiple Substances - CORRECT

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Multiple substances - INCORRECT

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FOR GATEWAY USERS

– ANIMAL SUSPECT SUBSTANCE XML SNIPPET – CORRECT

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– ANIMAL SUSPECT SUBSTANCE XML SNIPPET – INCORRECT

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2.7 Use of the look-up tables

The available look-up tables and Product and Substance dictionaries are sometimes not used to their full potential. In some instances, Product and Substances names have been manually entered using the “Text Edit” function, when the correct entries were already available in the Product / substance dictionary and can be selected via the look-up function. These “Text” entries need 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”.

If the relevant product is not available in the dictionary, please provide as much information as possible on the other fields in the “Product section” such as the “Authorisation number”, “Authorisation country”, etc. This will make the recoding process much easier when the product eventually becomes available in the dictionary.

2.8 For NCAs: Same Adverse Event, multiple MAHs[1]

In cases where an animal has been given 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 AE report that will be forwarded to EVVet. Once all the information is collated into a single AE report, the CA should inform all the involved MAHs of the Worldwide case number of this AE report sent to EVVet, in order to avoid duplicates and to ensure that any subsequent follow-up is correctly numbered and identifiable as such.

2.9 For MAHs: Best practice guidance on causality assessment

Following discussions at the JIG meeting on 17 July 2013, the following agreement has been reached with regards to the inclusion of Causality assessments by MAHs:

When a case originates with a MAH, the MAH should always enter a causality assessment for the product(s) for which they are responsible. However, when the case originates with a NCA, it has been agreed that MAHs should not submit follow-up reports where the only new information to be added is the MAH’s causality assessment.

Following discussions at the CGPhVS meeting on 29 April 2015, the following agreement has been reached with regards to the inclusion of Causality assessments by MAHs:

The MAH should add causality assessment for all products under its responsibility even if some of these products have been classified as concomitant.

Please also see the section on when to send follow-up reports for further guidance.

2.10 Reporting requirements in relation to clinical and marketing trials

Adverse events having happened in any trial should not be treated differently compared to Adverse Events occurring in e.g. daily practice conditions. Advice from the EMA legal team had clarified that legislation does not include specific guidance in relation to trials, hence normal requirements would apply.

For marketed products, serious cases resulting from clinical trials should be submitted within 15 days, as stated in Volume 9b. In general, the NCAs view is also that for e.g. a trial examining a new indication with a new species, AEs should be reported within 15 days, as reporting is required for any “off label use”.

It is also remarked that national legislation regarding clinical trials still applies and it is considered that the close surveillance of clinical trials through the mandatory reporting of potential adverse events to the hosting Member State is an important tool for the Member State to exercise control during a trial.

Non-serious adverse events occurring during on-going trials are often only made available after closure of the final study report and it was recognised that these reports would then be included in the next PSUR.

3. How to avoid sending duplicate reports and how to deal with duplicates sent to EVVET

A review of the existing duplicates in EVVET using the Duplicate detection application reveals that there are two main causes of duplication:

• Organisations changing the worldwide case number when sending follow-ups

• MAHs sending EEA cases directly to EVVET as well as to the relevant NCAs, and the NCA then send the case to EVVET with a different worldwide case number.

Therefore, in order to mitigate this problem, MAHs should never send EEA reports directly to EVVET, and all organisations should take care to never change the worldwide case number when sending follow-up reports.

All registered organisations should familiarise themselves with the “reporting schemas” (Schemas for the Guidance on the Electronic Data Interchange) available on the EVVET website, which explain the reporting workflow for MAHs and NCAs for all types of reports.

There are two separate procedures to deal with suspect duplicates in EVVET, depending on the type of report. With regards to old cases, and for non-EEA reports, duplicates will be detected either via routine screening performed by the EMA, where confirmed duplicates are then linked using the duplicate detection application, or by NCA assessors when running the Signal detection procedure. The assessor should inform the EMA about the suspect duplicates, so the cases can be linked via the duplicate detection application

For recent EEA reports, when a suspect duplicate is detected the following procedure should be followed:

The reports need to be compared thoroughly to establish the similarities and differences in the data entry between the reports. There are two possible outcomes:

1 - the reports, although similar, are not duplicates, so nothing else needs to be done

2 – the reports are confirmed to be genuine duplicates, in which case, the next steps need to be followed:

• The organisation that has discovered the suspect duplicate contacts the other organisation (s) involved.

• the NCA, in agreement with all parties involved, determines which report is to be kept, and nullifies the duplicate report(s), after including in the report that is to be kept any additional information from the report(s) to be nullified. The nullification procedure in EVVET is also explained on this guidance document. The “kept” report with all information should be sent to all parties so any subsequent follow-ups are done using the correct worldwide case number.

4. Guidance on the use of the Web trader: generation of acknowledgment messages and follow up reports

The EudraVigilance WEB Trader function is used for the receipt, tracking and download of AE reports and Acknowledgement messages by non-gateway EudraVigilance users.

The messages are displayed in two folders, an Inbox and an Outbox (and subfolders therein). These folders have been designed to aid workflow by mimicking the look and feel of an email system, such as Outlook. From the Inbox, you can view the AE reports and acknowledgement messages other users have sent to you. From the Outbox, you can find the AE reports and acknowledgement messages that you have sent to other organisations. AE reports and acknowledgement messages are displayed in separate subfolders.

The WEB Trader may also be used to create and send an acknowledgement message in response to incoming messages. Once a safety message has been validated an acknowledgement is created depending on the outcome of the validation.

From the EVWeb interface click the WEB Trader button and the following screen is displayed:

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Double click on ADRs and Product Msgs to display the following values:

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• Show Unprocessed Msgs – displays messages not yet processed.

• Show In-process Msgs – displays messages which are still being processed by the user.

• Find Processed Msgs – search to find processed messages.

To retrieve new messages from the server, click Refresh to gGet New Messages. The following screen is displayed:

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Click OK. The screen displays the Unprocessed Messages.

4.1 How to create an acknowledgement for a message received in your Inbox

Select the message (s) you want to acknowledge by ticking the small square box and click Send Ack.

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This will validate the checked message(s) according to the EMA business rules and generate an acknowledgement message, which is then automatically sent to the appropriate message sender.

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From the screen below the messages have been Acknowledged and the time and date of the Acknowledgement is displayed.

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4.2 Processing messages received in your Inbox

When a message has not been fully dealt with, you may wish to place it in a separate “In process Msgs” folder and return to it at a later time. Select the message and press Mark as In Process.

[pic][pic]TThe messages are placed in the In-process folder. The system notifies you of the success of the operation.

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To mark messages as processed, select the message(s) and click Mark as Processed.

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Click OK to continue.

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The messages are successfully processed. The system notifies you of the success of the operation.

To find Processed Messages, click Find Processed Msgs, select and enter criteria into the various search fields:

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Click Run. The following displays the processed messages that meet the criteria selected:

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You can also search for Acknowledgements using Find Ack from the Outbox.

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4.3 How to create a follow-up for process a case report received in your Inbox

Go to “Web Trader”, “Inbox”, “Show Unprocessed Msgs”, and then click on “Get New Messages” to refresh the unprocessed messages inbox.

First, send an acknowledgement message to the sender by clicking on “Auto Ack” to inform the sender that you have received the message. This process also validates the received message against the EVVET business rules.

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View the acknowledgement that you have sent so you can check whether the message you have received is correct and does not contain any errors. To load the acknowledgement, go to the “Outbox”, “Find Ack”, “Conditions (AND)”, then enter the “Send date”, and press “Run”:

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On the right hand side of the screen, select the acknowledgement that you want to view so that it turns blue, and press “Remote Import” to load it.

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Click on “Message Acknowledgement”. If the field “Message Acknowledgement Code” says “All safety reports loaded”, it means that the message you have received is correct, and you can continue processing the report.

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If the “Message Acknowledgement Code” says “Not all safety reports loaded”, it means that the report(s) in the message contain an error. The sender needs to correct and resend the erroneous report, so you should not process it.

Processing correct reports:

Return to the “Inbox”, “Show Unprocessed Msgs” area. Select the message that you want to process so that it turns blue, and press “Remote Import” to load it.

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The file will 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”.

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The AE 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.

Please note that when forwarding a report you received in your Inbox to EVVET, you should never change the original “Worldwide case number (R.05)” assigned to the case by the original user. However, you should change the “Report identification number (R.01)” to your own organisation number.

To add your “Causality Assessment”, go to “Animal data”, “Animal Suspect Drugs”, and click on the name of the product (s) “Product X” to which you want to add your assessment. Click on the “Assessment” Section (There should be 1 assessment there already from the sender organisation) and tick the box next to “New”. Fill in the mandatory fields “Source of assessment” and “Assessment classification” with appropriate information, and enter any further information on the text field “Assessment comment” if necessary.

Before validation, you have to give the case a Message Number otherwise the system does not allow you to submit the case. It is also necessary to select one or more Message Receivers. After validation, the AE report can then be sent to the EV system (if you are a NCA) or to the NCA (if you are a MAH).

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Go to “Web Trader”, “Inbox”, “Show Unprocessed Msgs”, and then click on “Get New Messages” to refresh the unprocessed messages inbox.

For cases you have already dealt with and archived, go to “Show In-process messages” or “Find processed Msgs”, depending on where you have manually archived the case you wish to “follow-up”.

When the results appear on the right hand side of the screen, select the message that you want to follow-up so that it turns blue, and press “Remote Import” to load it.

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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”.

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The AE 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 AE report 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.

Managing your Inbox

When a message has not been fully dealt with, you may wish to place it in a separate “In process Msgs” folder and return to it at a later time. Select the message and press Mark as In Process.

[pic]TThe messages are placed in the In-process folder. The system notifies you of the success of the operation.

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To mark messages as processed, select the message(s) and click Mark as Processed.

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Click OK to continue.

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The messages are successfully processed. The system notifies you of the success of the operation.

To find Processed Messages, click Find Processed Msgs, select and enter criteria into the various search fields:

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Click Run. The following displays the processed messages that meet the criteria selected:

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You can also search for Acknowledgements using Find Ack from the Outbox.

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4.4 Best practice on generation of acknowledgement managements and generation of follow-up reports

• Acknowledgement messages:

Any organisation, being a MAH or CA, that has received an electronic AE 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 on the tutorials section on the EVVET website.

Any organisation, being a MAH or CA, that has sent an electronic AE message should always check that they have received a valid acknowledgement message from the Receiver Organisation as soon as possible. If the acknowledgement message informs the sender that the message they sent contained an error, they should correct the error and resend the message as soon as possible.

Any organisation, being a MAH or CA, which has received an electronic AE 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 on the tutorials section on the EVVET website.

• 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.

5. How to save an unfinished AE 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

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Then, click on “here” to open the XML version of the file

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Next, click on “File”, “Save as”

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You can then save the file on any folder in your computer by giving it a name of your choice:

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To upload the file in EVWEB for further processing, open EVWEB, go to “Webtrader”, and click on “Local Import”.

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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”.

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The following message will appear on the screen. Press “OK”.

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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.

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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”.

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The AE 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.

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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”

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Then click on “Message receivers”. Double-click on either “EMEA”, “Pharmaceutical Company” or “Regulatory Authority”, depending on who your intended receiver is.

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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.

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After validation, press “Send”. The message will then be sent to your chosen receiver(s).

6. How to nullify an AE report sent by mistake to EVVET

If something goes wrong with you report (e.g. wrong worldwide number, or you later find out that the report you have sent is not a real report etc.), you can nullify it.

First, retrieve the case you wish to nullify by running a query on the “ADRs” section.  The quickest way is to click on “Safety Reports” on the left hand section of the screen, then enter the case number on the blank search field on the right hand side, then press enter.

Select the report by ticking the small square box next to the Report ID; the report will be loaded on the left hand side of the screen.

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Click on the Report ID number;  the “Edit” button will appear on the toolbar. 

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Click on “Edit”.  The system will take you to the “Create and send ADRs” section. 

To mark the report as a “Nullification case”, click on the field “Nullification report”, and enter “Yes”.

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On the field “Nullification reason”, enter your reason for nullifying the report, e.g. Invalid report, duplicate report…

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To send the “Nullification message”, you will need to give the message a “Message number”, select “EMEA” as the receiver on the “Message receivers” section, and press “Send”.  

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[1] Agreed at VetJIG meeting 21 October 2009

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