Understand the Clinical Study

There are several areas of study that will help you understand the research topic. As a first step you will want to read the clinical protocol. The protocol describes the device or medication to be used, the patient populations under study, the statistical plan of the clinical trial, and the details of the disease state. If you want to understand the disease state or indication further, you may want to seek out a clinical investigator of the clinical trial or do some further reading about the disease. Understanding the patient population is a good way to understand the data that you will see and whether there is reason for concern when viewing the data. For example, if you were studying a medication to reduce hypertension, you would not be as worried if patient blood pressure data were elevated at baseline. You would expect to see this because you understand that hypertensive patients have high blood pressure. 

Finally, there is the very important annotated CRF, which shows you where the variables in the clinical database come from on the CRF. The following is an example of an annotated medical history CRF page  

Protocol Name study Patient Number - patid Visit Identifier visit  

Note that in this example the data set and variable names are in italics and are enclosed in angle brackets ( ). Also note that there may be external data (from the laboratory, 

ECG Holter monitor, etc.) loaded into your clinical data management system, and you will want the specifications for those data as well. 

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