The fda’s guidance on electronic source data in clinical investigations promotes capturing source data in electronic form and provides recommendations for source data in clinical investigations used to complete an ecrf. Percent changes in quarterly seasonally adjusted series are displayed at annual rates, unless otherwise specified. To clearly understand the data generated during a clinical research study, it's important to differentiate between source documents, study worksheets, and case report forms (crfs), as well as their purpose, creation, and use. “the investigator/institution should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site's trial subjects Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Source data is defined as all information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial.
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