PSMF Annex D
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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?
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