ABSTRACT
Having produced the data, the next steps are to analyze the data and summarize the observed effects using experience and statistics where appropriate.
The laboratory’s standard operating procedures should ensure that data in paper or electronic format are stored securely. Editing of data must be properly tracked with reasons for changes and must identify the person making data changes, and the person changing data must be authorized to make such changes. The constitution of the raw data must be described, as these data must be retained and eventually archived for regulated studies. Some of the denitions and requirements for electronic raw data are outlined by a FDA guidance document (Food and Drug Administration, 2003).
