This extra knowledge in pharmacovigilance blog covers:
- What “Day-Zero” means in pharmacovigilance.
- Recording and recognizing Day-Zero across different report types.
- The significance of Day-Zero in regulatory timelines for submissions.
- An uncomplicated tool for calculating days.
Table of Contents:
- Definition of “Day Zer(0) in Pharmacovigilance
- Capturing Day Zero in Records
- Recording Day Zero: Communication mode
- Figuring Out the Day for Submission
- Sophisticated Tool For Calculating the day from “Day Zero”
- Reports Fit and Unfit for Day Zero
- Conclusion
- FAQ
A “Day Zero” in pharmacovigilance
“Day-Zero” is the point when an organization identifies a report containing the basic criteria necessary for processing and meeting the requirements for Individual Case Safety Report (ICSR) submission.
In other words,“It is the date on which an organization becomes aware of a publication or the report containing the minimum information for an ICSR to qualify for submission.”
Capturing Day Zero in Records
According to guidelines, “Day-Zero” is the moment when anyone within the organization or a third-party contractor becomes aware of a report or publication that meets the minimum criteria for an Individual Case Safety Report (ICSR) submission. Applicable to both follow-up (FU) and initial reports.
“In the realm of drug regulatory affairs, submission of accurate reports serves as a beacon of accountability and transparency, ensuring the safety and efficacy of pharmaceutical products for the well-being of all.”
Recording Day Zero: Communication mode
The regulatory submission of each case is based on regulatory requirements and country-specific regulations. The day of submission for each case is calculated based on the initial receipt date, which is considered Day-Zero.
Initial reports are recorded when they are received by the company.
For example, it depends on the source (mode) of the report:
- Through email communications: Received instantly, but recorded after reviewing the report.
- Through mailing letter: May take time to reach.
- Through social media communications: Received instantly, but recorded after reviewing the report.
- Through telephonic communications: Immediate communication and immediate recording.
- When it comes to calculating Day-Zero for literature cases, it’s important to consider when the safety department actually finds the literature. Sometimes, the literature may have been written some time ago, but the initial report date should be marked as the date it was discovered by the safety department.
- For follow-up (FU) cases, even if the FU is received with an incomplete report, it should still be calculated with Day-Zero once the report meets the necessary criteria.
Figuring Out the Day for Submission
Firstly, many people confused about calculating the submission days, which can lead to rushing or delaying submissions. So, here is a clear clarification:
For instance, If a report is recorded on January 1st and the submission deadline is day 15, that means the 15th day would be January 16th.
When the day starts at zero, it should forward to the safety department within 24 hours of initial receipt. If the initial receipt day considered zero, then the first day (day 1) starts from the next day of “day-zero“. This calculation should be done in this manner.
The days calculated strictly as calendar days.
Calendar days: Calendar days refer to the total number of days on a calendar, including weekends and holidays. It’s different from working days (Business days).
Business days: Business days, also known as working days, typically refer to the days of the week when most businesses are open and operational. These typically exclude weekends and public holidays.
To help you avoid confusion in your calculations, we invite you to utilize our tool for better understanding of days.
Drug Regulatory Submission Timeline Calculator
Reports Fit and Unfit for Day Zero
- Fit when reports processed for ICSR case management
- Fit when reports needing to meet four minimum criteria
- Day Zero not calculated for invalid cases
- Fit when Invalid cases becoming valid in follow-up reports
Conclusion
This blog may cover some crucial points that discussed regarding the specific matter of Day Zero.
You may now have some ideas on how to record Day Zero and how to calculate the day of submissions. Hopefully, it is informative for many who are reading this blog.
If anyone would like to add any missing information discussed above, feel free to add it in the comments.
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