Date functional status evaluated:
Enter date of functional status testing. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

Date should be within the specified visit window in the protocol. If the assessment date entered is outside of visit window a protocol deviation should be logged in the EDC.

If the date entered is a future date, a query will appear in the EDC.

Karnofsky Performance Scale:
Use this scale (see Table 1) to determine the score (10-100) that best represents the subject’s activity status at the requested time point.

Table 1. Karnofsky Scale

Karnofsky Scale
100% – Normal, no complaints, no evidence of disease
90% – Able to carry on normal activity
80% – Normal activity with effort
70% – Cares for self, unable to carry on normal activity or to do active work
60% – Requires occasional assistance but is able to care for most needs
50% – Requires considerable assistance and frequent medical care
40% – Disabled, requires special care and assistance
30% – Severely disabled, hospitalization indicated, although death not imminent
20% – Very sick, hospitalization necessary
10% – Moribund, fatal process progressing rapidly

CCG v1.0 | CRF v1.3

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