Pharmacovigilance (PV)
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What coding systems (e.g MEDRA, SNOMED etc), if any, do you use for coding of AEs and SAEs? If you do use a formal coding system, who performs this coding and what training and resources do you use to support this activity. Our reading of the requirements for EudraCT End of Study reports is that AEs/SAEs need to be coded according to a formal system. Our concerns are that trial management staff are unlikely to havesufficient medical expertise to make the necessary judgments and that CIs are unlikely to have the time, inclination or indeed coding skills to do so.
Any feedback on how your CTU is tackling this issue would be much appreciated.
Thanks
Elaine
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