Decision to use E2B “clinical safety data management” for immunization data

Erika Whittome made this Official Information request to Ministry of Health

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From: Erika Whittome

Dear Ministry of Health,
I refer you to OIA response H2024036547 dated 21 March which Chris James says :

The COVID-19 vaccination database was a temporary database built to manage the increase in reporting through the COVID-19 vaccine rollout and link to the Covid Immunisation Register (CIR). As it was a temporary database, it had limited scope and restricted capabilities for recording non-essential information for pharmacovigilance. As for all reports to CARM the reporter chooses what information to report and individuals may choose not to disclose certain information for confidentiality reasons, leading to gaps in the database. Both the temporary pharmacovigilance database and the CIR have now been decommissioned.
The data from the now-decommissioned pharmacovigilance database has been transferred to an E2B compatible database (Database to Database transmission). The E2B fields are publicly available here: reports-icsrs-data-elements-message-specification-implementation-guide-scientific-guideline.

It appears from Mr James’ response is that all the immunization and pharmocovilligance data is now going into a format for “clinical” data . E2B is for “Clinical Safety Data Management”
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1 When did the Medafe quit using Salesforce to store adverse event reports ?
2 How much were the annual licensing fees for Salesforce for medsafe or the ministry of health for this safety monitor report from safesforce?
3 Did the ministry of health join or apply to join ICH? ( If so, please share the minutes for this decision to join?
4 Please share the procurement documents for agreeing to deploy an E2B system for immunization and safety data?
5 Please share the annual software licensing costs for this new E2B syatem.
6 Please share which vendor has supplied it?
7 Is this E2B data housed on NZ soil in NZ data centers? If not, where please?

8 How is the functionality of the E2B data format for “clinical safety data management” appropriate for the New Zealand population who are not in a clinical setting at all?
9 Please supply the RFP for this procurement of a new system to store immunization and safety/pharmocovilligance data .

Yours faithfully,

Erika Whittome

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