Lesson 1 of 3 · about 15 min
Day 0: when the clock starts
Every deadline is counted from Day 0. Day 0 is the date on which any personnel of the marketing authorisation holder or sponsor first receives the minimum information for a valid case. The next calendar day is Day 1.
A valid case needs four elements:
- An identifiable patient
- An identifiable reporter
- At least one suspect drug
- At least one adverse event
"Any personnel" is broad. It includes sales representatives, medical information staff, affiliates, and contracted parties. The clock does not wait until the case reaches the safety team. If a sales rep gets an email with all four elements on a Tuesday, Day 0 is Tuesday, even if safety sees it on Friday.
- Literature: Day 0 is the date the company becomes aware of a publication that holds the four elements
- Partners and licensees: the safety data exchange agreement says who reports and by when. Check it for every product
- Social media and digital sources: if the company reviews or sponsors the source and sees a valid case, the clock starts on that date
Worked example
A patient's daughter emails the medical information line on Monday 6 October with the patient's initials, age and sex, a named drug, and a rash. The reporter is identifiable by her email address and gives the patient as her mother. All four elements are there. Day 0 is 6 October. If the case is serious, the 15-day report is due on 21 October.