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PSMF Annex D

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  • Anon
    13/03/2015 08:28
    I'm trying to find out what should go into Annex D of the PSMF. The GVP Module II has no information on this just stating the title "Computerised systems and Databases". Options that I considered: 1. a full list of PV related systems 2. a repeat of the system listed in section 4 of the PSMF i.e. systems on covering "receive, collate, record and report safety information" 3. state "unused" as per guidance Can anyone provide some guidance?
  • Chris
    14/04/2015 10:27
    MHRA require that you provide a list of all PV systems (or systems that hold PV data)as follows: 8.1. Present Situation - global and local systems: Provide details of the computerised system(s)/database(s) used to collect, collate and evaluate information about suspected adverse reactions (e.g. spontaneously reported adverse drug reactions and solicited reports including clinical trial SAEs). Include: • Name and function with version details • Whether the system was developed commercially (and whether the system has been configured/customised following purchase) or in-house (bespoke) • Validation status (and where the validation documentation is located) • Details of the group(s) responsible for maintenance and support of the system
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