• To select “Yes” to this data element, BOTH of the following must be true:
  1. There must be a signed consent form for clinical trial. For the purposes of abstraction, a clinical trial is defined as an experimental study in which research subjects are recruited and assigned a treatment/intervention and their outcomes are measured based on the intervention received. Treatments/interventions most often include use of drugs, surgical procedures, and devices. Often a control group is used to compare with the treatment/intervention. Allocation of different interventions to participants is usually randomized.
  2. There must be documentation on the signed consent form that during this hospital stay the patient was enrolled in a clinical trial in which patients with the same condition as the measure set were being studied. Patients may either be 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 this hospital stay.
     PC:
     Only capture patients enrolled in clinical trials studying pregnant patients or newborns. For Perinatal Care measures ONLY, it is appropriate for the ORYX® Vendor to default the data element to "No" unless the ICD-9-CM diagnosis code of V70.7, "Examination of participant in a clinical trial" is present. If this code is present, or the organization knows via some other electronic method that the patient is participating in a clinical trial, default the data element to "Yes". Hospital abstractors may change defaulted value of "No" based on hospital participation in clinical trial.

• In the following situations, select "No":
  1. There is a signed patient consent form for an observational study only. Observational studies are non-experimental and involve no intervention (e.g., registries). Individuals are observed (perhaps with lab draws, interviews, etc.), data is collected, and outcomes are tracked by investigators. Although observational studies may include the assessment of the effects of an intervention, the study participants are not allocated into intervention or control groups.
  2. It is not clear whether the study described in the signed patient consent form is experimental or observational.
     It is not clear which study population the clinical trial is enrolling. Assumptions should not be made if it is not specified.

ONLY ACCEPTABLE SOURCES:

• Signed consent form for clinical trial

FOR PC ONLY

• UB-04, Field Locations: 67A-Q