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Schedule of Assessments Excercise - Master File

The document outlines the screening and dosing schedule for subjects in a clinical trial, starting with a subject on 1JAN2025 and detailing the end of screening on 28JAN2025. It provides calculations for Day 1 dosing and subsequent assessments, confirming a physical examination on Day 1 is correct. Additionally, it calculates the date and time for Day 337 assessment as 21JAN2026 at 7 AM.

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23 views2 pages

Schedule of Assessments Excercise - Master File

The document outlines the screening and dosing schedule for subjects in a clinical trial, starting with a subject on 1JAN2025 and detailing the end of screening on 28JAN2025. It provides calculations for Day 1 dosing and subsequent assessments, confirming a physical examination on Day 1 is correct. Additionally, it calculates the date and time for Day 337 assessment as 21JAN2026 at 7 AM.

Uploaded by

Semilogo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Subject begins screening on 1JAN2025

When will the subject end screening?: 1 JAN 2025 : Day -28
End of Screening will be Day -1: 1JAN2025 + 27 DAYS = 28JAN2025
End of Screening: 28JAN2025: Day -1

Date of Day 1: Day -1 + 1 Day = 28JAN2025 + 1 = 29JAN2025

If a subject that began screening on 1JAN2025, had informed consent collected


on the 29JAN2025, is this data correct?

Treatment: Day 1 0H: 29JAN2025, 7:00 am


Day 1 2h: 29JAN2025, 9:00 AM (8:30 - 9:30)
Day 1 6h: 29JAN2025 13:00 (12:30 – 13:30)
Day 4 72h: 01FEB2025, 7 AM ( 4 AM – 11 AM)

Assignment
A subject begins screening on the 22JAN2025. Day 1 dosing time is 7 am.
1. Calculate date of Day 1 Dosing
2. Calculate day and time of Day 4 assessment
3. The subject had a physical examination on 19FEB2025. Confirm if this is
correct or wrong, with reasons
4. Calculate the day and time of Day 337 assessment
The two screenshots of the schedule of assessments below has all the
information you need. Submit to [email protected], by Monday, next week.
Also take into account the visit windows

Solution to Assignment
1. Screening Began on 22JAN2025. Calculate Day1?
Day -1 = 22JAN2025 + 27 days = 18FEB2025
Day 1 = 18FEB2025 + 1 Day = 19FEB2025

2. Date of Day 4 = Day 1 + 3 Days


19FEB2025 + 3 Days = 22FEB2025
Time of day 4 = 7 am (3 am to 11 am)
3. 19FEB2025 is Day 1 Visit. Per the schedule of assessments, this is right as
Physical Examination should occur on Day 1
4. Date and time of Day 337 visit:
Day 1 + 336 Days = 19FEB2025 + 336 = 21JAN2026 (14JAN2026 -
28JAN2026)
Time: 7 am

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