Height and BMI Clause Samples
Height and BMI. Height measurements (cm) and BMI will be determined by the site at screening only. Height measurements should be made without shoes. BMI will be calculated for purposes of screening using the IVRS. A printed copy of the BMI obtained from the IVRS should be retained as part of the subject’s source documentation. Manual BMI calculations should not be performed. If a subject does not meet the BMI criterion for inclusion into the study, no further screening procedures should be undertaken.
Height and BMI. Height measurements (cm) and BMI will be determined by the site at every visit (see BMI Chart in Appendix 2). Height measurements should be made using a calibrated stadiometer without shoes, socks, or hats. At each study visit, 3 independent measurements of height should be made, and the median value from these measurements recorded on the eCRF. Height should be recorded to the nearest centimeter. The same stadiometer should be used for all visits for any given subject. Stadiometer should be calibrated, at least daily, if used, following the equipment’s manufacturer instructions and/or site SOP. If a subject does not meet the BMI criterion for inclusion into the study (see CDC Clinical Growth Chart8 in Appendix 3), no further screening procedures should be undertaken.