This example illustrates the data collected for the Swollen/Tender Joint Count assessment, specifically the 68-joint count. After determining whether each joint is swollen or tender, the assessor will add up the number of "Yes" responses for swollen joints and tender joints to obtain a total count for each. Entering these total counts into the CRF is at the sponsor's discretion, since they are typically derived in the ADaM datasets.
In this example, the total counts are not collected on the CRF for this reason. There is a field for marking a joint Not Evaluable when that joint meets a condition (e.g., infection of the overlying tissue or skin, grossly edematous, fused), which precludes joint assessment and is specified by the protocol or the protocol-related joint-assessor training. In general, capturing the reason that a joint is not evaluable is not needed; thus a field for "reason not evaluable" is not provided in the example. Note that there is a field for marking a joint assessment as Not Done; this is to be used if the joint assessor overlooked or missed that joint while performing the joint assessment.