Question: Abstraction for Clinical Trial (STK)

Patient assigned an ICD-9-CM Principal Diagnosis Code 433.10, and enrolled in a research study for "Gore Embolic Filter in Carotid Stenting". Can "Yes" be abstracted for Clinical Trial (STK), if the patient was admitted for this procedure?

Answer:

To select 'Yes' for Clinical Trial (STK), two things are needed. There must be a signed consent form for the research study present in the medical record, AND documentation on the signed consent form that the patient was enrolled in a clinical trial in which patients with stroke are being studied. Patients may be either newly enrolled in a clinical trial during the hospital stay, or enrolled in a clinical trial prior to arrival and continued active participation in that clinical trial during the hospital stay.