Source document

Source Document

A source document (pronounced: /ˈsɔːrs ˈdɒkjʊmənt/) is a document in which data collected for a clinical trial is first recorded. This data is usually later entered into a case report form. The International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP) defines source documents as "original documents, data, and records".

Etymology

The term "source document" is derived from the English words "source", meaning "a place, person, or thing from which something originates or can be obtained", and "document", meaning "a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record".

Related Terms

Case Report Form: A document that is used in clinical trials to collect data in a standardized manner. It is often derived from source documents.
Clinical Trial: A type of research study that tests how well new medical approaches work in people. Source documents are often used in clinical trials to record data.
Data Collection: The process of gathering and measuring information on variables of interest, in an established systematic fashion that enables one to answer stated research questions, test hypotheses, and evaluate outcomes. Source documents are a key part of data collection in clinical trials.
Good Clinical Practice: An international quality standard for conducting clinical trials that includes guidelines for source documents.
International Conference on Harmonisation: A project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The ICH has established guidelines for source documents in clinical trials.