Understanding "Source Clear Number" in Medical Documentation

In the context of medical documentation, particularly within the phrase "date of UK EC approved version) – Document No. (Source Clear number)", the term "Source Clear number" refers to a unique identifier assigned to a document to indicate its status as a finalized, approved, and controlled version, often signifying that it has undergone a "source clear" process. This process ensures that the document is free from errors, ambiguities, and has received all necessary internal and external approvals before its official release or use. It's a critical component of quality management systems in regulated industries like pharmaceuticals and medical devices, where document control is paramount for patient safety and regulatory compliance.[1]

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The "Source Clear number" acts as a version control mechanism, providing an auditable trail for the document's lifecycle. It signifies that the document, such as a clinical trial protocol, a manufacturing batch record, or a regulatory submission, has been reviewed, approved, and is considered the definitive version for its intended purpose at that specific date.[2] This number is distinct from a simple draft number or an internal tracking number; it carries the weight of official endorsement. For instance, in the UK, the "EC approved version" likely refers to approval by an Ethics Committee (EC), which is a body responsible for reviewing research proposals to ensure the protection of the rights, safety, and well-being of human participants.[3] The "Source Clear number" would then be the final identifier assigned after this EC approval and any subsequent internal quality checks.

Importance in Regulatory Compliance

The concept of a "Source Clear number" is deeply embedded in regulatory frameworks governing the medical and pharmaceutical industries. Organizations like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) emphasize robust document control to ensure the quality, safety, and efficacy of medical products.[4] [5] A "Source Clear number" helps demonstrate compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other relevant regulations by providing clear evidence of document finalization and approval. Without such a system, tracking approved versions and preventing the use of outdated or unapproved documents would be challenging, potentially leading to serious regulatory non-compliance and risks to public health.

Practical Application

In practice, the "Source Clear number" might be generated by a document management system (DMS) or a quality management system (QMS) once all required signatures and approvals have been obtained. It often appears alongside other critical metadata, such as the document title, version number, and effective date. For example, a pharmaceutical company submitting a new drug application to the MHRA would ensure that all supporting documents, like clinical study reports and manufacturing process descriptions, bear a "Source Clear number" to signify their official, approved status.[6] This ensures that regulators are reviewing the most current and validated information.

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