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June 25, 2020 at 9:33 am #42221Helen SeurinParticipant
Please can PV colleagues share how they deal with the date of receipt for ICSRs in different time zones? For example, if a company has a product in the UK but comments on social media are handled by a service provider in an EU country with a 1 hour time difference what is the date of receipt in the following example: a patient in the UK posts a comment (which contains an event) on a company’s website just before midnight on one day (e.g. 11.30 p.m. on 20th April) but the service provider is 1 hour ahead, so it would be 12.30 a.m. on 21st April.
Hope you can help. Many thanks in advance.June 29, 2020 at 2:09 pm #firstname.lastname@example.orgParticipant
Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.
Dear PIPA Member,
Thank you for your enquiry regarding the date of receipt for ICSRs in different time zones.
As per GVP VI – Section VI.B.1.1.4. Information on suspected adverse reactions from the internet or digital media, the frequency of the screening should allow for potential valid ICSRs to be reported to the competent authorities within the appropriate time frame based on the date the information was posted on the internet site/digital platform.
Where different time zones may be a factor, a consistent and documented approach should be taken.
In the example given, this may could be that UK time zone will be used for the receipt date, the time zone of the service provider or the date stamp of the poster on social media. However, once agreed, this should not then be deviated from (i.e. if the service provider then opened an office in the UK and screening was conducted there too, both offices should be working to the same Day 0 time zone). Whichever approach is chosen, the key is consistency.
I do hope this answers your query.
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