Proposed Generic EBF Lab Manual - EBF Focus Workshop 'Lab Manuals ... 2026

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The document serves as a proposed template for laboratory manuals used in Phase I and Multi-Centre PK Clinical Trials, focusing on the processes of labelling, sample collection, handling, storage, shipment, and retention of biological samples. It emphasizes that while the guidelines are not regulatory requirements, they aim to standardize practices across the industry. The manual includes detailed sections on various aspects such as equipment needed, sample processing procedures, and documentation required for sample management.

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Click ‘Get Form’ to open the Proposed Generic EBF Lab Manual in the editor.
Begin by filling out the Title Page section. Enter the Study Number, Sponsor Name, Clinical Study Protocol Title, Date, Clinical Study Phase, Protocol Version, and names of the Study Manager and Author.
Navigate to the 'Contacts / Key Personnel / Responsible Staff' section. Input relevant contact details for each key personnel listed, ensuring accuracy for effective communication.
Proceed to complete the 'Documents / Information' section. List all necessary documents required prior to sample collection and ensure they are marked as available at both the Clinical Unit and Bioanalytical Lab.
In the 'Supplies' section, specify all sample collection tubes and transport tubes needed for your study. Include details such as volume and supplier information.
Fill out the 'Sample Handling and Collection Procedures' section by detailing specific conditions for blood/plasma/serum samples or urine/faeces samples as applicable.

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