- This topic has 1 reply, 2 voices, and was last updated 6 months, 3 weeks ago by .
- You must be logged in to reply to this topic.
Home › Forums › Pharmacovigilance Forum › EMA R3 requirements detailing the mandatory null flavour codes.
With the updated EMA R3 requirements detailing the mandatory null flavour codes.
Can we ask how other MAH’s have adapted their ICSR processing to differentiate:
1. Between UNK and ASKU i.e. if Day 0 source information has not fulfilled the 20 mandatory null flavour codes – is this being processed as NASK or UNK
2. For serious cases meeting expedited reporting requirements, where the null flavour codes have not been established, and follow-up attempts are being processed – how are the ASKU versus NASK versus UNK being captured (as they will not be clear until follow-up is received).
3. Where follow-up attempt with the reporter is not possible (lost to follow-up ICSR scenarios) – this will possibly be known only after the third and final follow-up attempt and therefore majority of ICSRs will be coded with ASKU?
Dear PIPA Member,
Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.
Unfortunately, no one within the Committee are unable to advise on this, we would therefore advise that you seek further clarification from the
ICH guideline E2B (R3) – questions and answers document
We apologise for not being to provide guidance on this occasion.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
|cookielawinfo-checkbox-analytics||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".|
|cookielawinfo-checkbox-functional||11 months||The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".|
|cookielawinfo-checkbox-necessary||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".|
|cookielawinfo-checkbox-others||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.|
|cookielawinfo-checkbox-performance||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".|
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.