Biomedical Engineering Reference
In-Depth Information
Exclusion/inclusion criteria : Some now refer to inclusion criteria in a politically correct
manner - it is not. Both relate to the selection of subjects for a study. The inclusion
criteria select those who must be in the study; for example they must have a broken leg.
Those to be included in the study should be those whom your device is intended to treat.
The exclusion criteria, effectively, removes subjects (from the inclusion set) from the
study - normally any one from a list. Typically this may be smoking or drug dependency,
but it could be children and/or the aged.
Data requirements : You should try to imagine all the data you may need and list them. It
is actually better to collect as much information as possible. However, some data may be
Medical DeviceCo Inc.
Clinical Study Spcification
Project Number
Product Title
1. Target population:
2. Regulatory and statutory:
3. Exclusive criteria:
4. Data requirements:
5. Suggest study type:
Approved/Not Approved
Approved by:
Date: 17.5.2010
version 1.0
Figure 9.21
Example clinical study specification pro forma.
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