Abstract
The planning stage of a clinical trial includes the design of source documents. Source Data are contained in Source Documents (original records or certified copies). The term ALCOA is widely used to describe the fundamental elements of source data. Source Documents are all written and printed documents that are relevant to a participant’s exposure to the investigator product, other treatments, progress of the disease course, and response to therapy. Source documents are your way of telling the story of the clinical trial as you have progressed, according to the trial-specific protocol. The principles of ICH-GCP regarding source documents should be adhered to including the responsibility of team members. Clear, concise source documents ensure accurate data entered into the database, and will cut out a lot of data queries.
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