Endpoint Committee CEC Data

Protocol Name Patient Number Visit Identifier 

Other supportive data fields go here to verify that the event happened.  

In this CEC form, event would be replaced by some clinical finding such as myocardial infarction, stroke, seizure, or the like. Once again, this form is extremely simplified, and there are usually a number of associated data variables captured that help to support the existence of the event. 

The clinical endpoint committee data are almost always used for efficacy analyses, but they may also be used for safety analyses. From a CDISC perspective, the endpoint/assessment is considered a finding, as it is a planned examination. 

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Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

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