Study Day/Range and Counting Numbers Number
What is Study Day/Range? Why do I need it?
In clinical Study enrollment of Subjects takes some time, usually months.
It means that one Subject can be at the end of his/her treatment protocol while others are in the beginning or in the middle of it, which means that it might not be correct to analyze their vital signs or any other parameters for a specific date.
For example, in case of an oncology study with very high probability the Subject who has just finished chemotherapy had lost a lot of his/her weight and if we compare his/her weight with other Subjects who have just started their treatment the first Subject will be considered as an outlier (due to big difference) but it is not correct.
In order to solve this problem for the retrospective analysis we need unified time parameter what will allow us to compare Subjects who entered the Study in different moment of time.
This unified time parameter is named Study Day.
Date when a Subject first time appeared in the Study Data Set is considered as Study Day 1.
So, we take Subject 1 and assign Study days for him/her: Sept 1st = Study Day 1,
Sept 2nd = Study Day 2 etc.
And we do the same for all Subjects
Subject K:
Nov 4th = Study Day 1,
Nov 5th = Study Day 2 etc.
In this case, if we select the same Study Day for all Subject, we will compare Data item values properly (i.e. weight will be compared for 5th Study Day for all Subjects) and probability of statistical errors what can be caused by different enrollment days will be significantly lower.
It is also possible to select not only a single Study Day but Study Day Range. For example, since Study Day 1 to Study Day 10.
Please note that Cyntegrity doesn't recommend select long Study Day Range.
NOTE: For other levels (Site, Country, Study) the first Study Day will be calculated as the first date when an entity (for example Site N1) at the selected level (Site) appeared in the Study Data Set.
It is possible the Data Item was measured several times during a Study Day (for example Heart Rate).
Values of these measurements might be very different (for example before and after injection). In this case, if a user makes a CSM Request for all measurements what were made during the Study Day it may cause statistical errors and wrong conclusions.
In order to allow users to make analysis for concrete measurements “Counting Number” parameter was added.
Imagine that following the protocol there were 5 measurements of Heart rate made.
1st, 2nd and 3d measurements were made before and between injections of an Investigational Product while 2nd and 4th measurements were made just after the injection, and it is expected that IP should affect the Heart Rate significantly.
It means that statistical analysis for measurements 1,2,3 and 2,4 should be made separately or used as separate Data Items (i.e. presented in separate columns) in the CSM Request.
NOTE: If Select “Study Day/Range” Option was selected Counting number can't be empty.