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Paper ADR Reporting Forms

The Paper ADR Reporting Forms guidance discusses points to consider when designing a new or updated form and provides examples of good practice from the European Union NCAs, which can be used as a point of reference for NCAs when tailoring a form for their own requirements.

What does this document cover?

1. Introduction

2. Survey results

3. Points to consider when designing a form

 - Prototype development

 - User testing

 - Content of the form

 - Layout and design

 - Language used

 - Types of form

4. Guidance, background and supplementary information

 - Introduction on why to report suspected ADRs

 - What to report

 - How reports are used

 - Who to report to

 - Methods of reporting

 - How to complete a form

 - Medical advice

 - Links to further information

5. Availability

6. Feedback

7. Conclusions

Annex - Fields to include on a paper form

Target audience

The target audience is primarily pharmacovigilance staff working at National Competent Authorities.


41 page pdf.

Click here to access this document

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