Electrocardiogram data

Subjective data (ie, the patient s complaints or description of symptoms) also are obtained at this time The primary health care provider usually orders an electrocardiogram. Additional diagnostic studies and laboratory tests also may be ordered. 

Electrocardiograms and Cardiovascular Measurements. The availability of excellent GLP-validated telemetry systems has led to recent increases in the number of cardiovasular safety pharmacology studies conducted in primates. In addition, telemetry is now sometimes included as a design element in standard safety studies. Because of the ability to collect large amounts of high quality data over an extended time, total numbers of animals can often be reduced by appropriate application of... 

Case report form data are complete and can be verified with the source documents. Case report forms should be completed with a black ballpoint pen, and the print should be legible. Ensure that corrections, additions, or deletions are made, dated, and initialed by a member of the research staff authorized to initial CRF changes for the investigator. Laboratory parameters that have to be transcribed into the CRF must have each data point reviewed closely. Original reports (e.g., electrocardiogram, X-ray, Pap smears) should have copies made and inserted into the CRF. To maintain confidentiality, these reports need to have the subject s name blacked out, leaving only the initials visible. 

Although early studies suggested that gatifloxacin has little effect on the QT interval of the electrocardiogram (7,12), clinical trial data and data from phase IV studies... 

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