Normal Reference Range Vs Pre-defined site normal values [Design Issues]

posted by cakhatri – India, 2019-12-17 12:35 (1578 d 03:41 ago) – Posting: # 20980
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Dear All,

Below is the response from WHO for a protocol review for a BA/BE study on healthy volunteers and for submission to WHO. Request the members to clarify what WHO means for "Laboratory Reference Ranges or Interval"and "Pre-defined site normal values" or "Site normal range"

The list of laboratory reference ranges or intervals are included in Appendix 5. Please note that as this study is conducted in healthy volunteers, subjects should be recruited into the study only if their health is fully verified, including verification that serum biochemistry and haematology parameter values are within pre-defined normal ranges. The enrolment of a subject with measured values for the health verification parameters that fall outside the pre-defined site normal values should not occur, except on a rare, exceptional basis. On the rare occasion when a subject is enrolled in a study despite having a measurement outside the site normal range, the study physician should have a clearly documented and medically rigorous justification for making that exception. Good Clinical Practices (GCP) require that the rights, safety, and well-being of trial subjects be given top priority in every trial conducted.

My understanding on this is

The site can have a set of values pre-defined based on the reference ranges set by the clinical laboratory. These pre-defined values will be set by the Physician at his/her own discretion along with medical examination & medical history and can consider for enrollment of the volunteer into the study

To cite an example
A. Laboratory Reference range for Haemoglobin - 13-18 g/dL
B. Pre-defined Site Normal range for Haemoglobin - > 12.5 g/dL

B has been set by the physician at his/her own discretion

Can "B" value be used for enrollment of a volunteer into the study

Regards / Chirag

Edit: Category changed; see also this post #1[Helmut]

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