Reply To: ICSR date of receipt – time zones

Home Forums Pharmacovigilance Forum ICSR date of receipt – time zones Reply To: ICSR date of receipt – time zones

#10803

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.

Kindest regards

PIPA