LOE Expedited reporting
LOE Expedited Reporting Quiz
Test your knowledge on the latest updates regarding the LOE (Lack of Efficacy) reporting requirements. Whether you're a seasoned professional or new to the field, this quiz covers essential aspects of expedited reporting.
In this quiz, you will learn about:
- Latest reporting requirements
- Types of cases included
- Exclusions and their implications
- Submission timelines and processes
What is the latest update on the LoE reporting requirements?
Spontaneous ICSRs of LOE with or without an additional AE for company Oncology products must be captured as serious valid ICSRs.
ICSRs of lack of efficacy with or without an additional AE for medicinal company products used in critical conditions or for the treatment of life-threatening diseases must be captured as serious valid ICSRs
Both
Current process include what type of cases?
Spontaneous
Solicited
Interventional CT
Both A and B
What type of cases are excluded in this planned deviation
Outcomes for which the reporter has stated it is due to disease progression and was not related to the medicinal product
Non-Interventional Post Authorization Efficacy Studies (when the report is in respect of the main endpoint of the study)
COVID-19 scenarios
Interventional CT
This process is effective from?
11-OCT-2020
12-OCT-2020
13-OCT-2020
14-OCT-2020
A watchlist action will trigger to refer to a list of products with critical and life-threatening indications which can be found in the GMS Portal link
True
False
Who is required to review LOE reports to ensure criteria for expedited submissions is met
Oversight SSP
Internal PVP
DSA
Both A and B
If in a particular case if that drug was was used for an unapproved indication, should the event of LOE be considered as
Serious
Non serious
Is this applicable for already existing LoE event cases?
Yes
No
In which WI is this updated information available?
TV-WI-10316
TV-WI-10317
TV-MAN-00556
None of the above
Per GVP Module IV reports of LOE with no suspected adverse reactions are required to be submitted within?
5 Calendar days
7 Calendar days
11 Calendar days
15 Calendar days
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