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.
Duration
41 page pdf.
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