№ files_lp_4_process_2_89711
Guidance document detailing the procedures for evaluating, selecting, and monitoring external laboratories for compliance with GCP standards in clinical trials, including delegation of responsibilities, assessment processes, and documentation requirements.
Year: 2026
Institution: University of Birmingham
Type of document: Standard Operating Procedure (SOP)
Scope: Clinical trials of investigational medicinal products (CTIMPs)
Responsible parties: Chief Investigator (CI), Clinical Research Compliance Team (CRCT), Clinical Trials Unit (CTU), Human Tissue Oversight Committee (HTOC), Research Governance Team (RGT)
Purpose: Assess and ensure external laboratories comply with Good Clinical Practice (GCP) laboratory standards
Implementation date: 2026
Relevant regulations: European Medicines Agency - Reflection paper for laboratories analyzing clinical trial samples
Key outputs: Completed self-assessment questionnaire, documented oversight records, contractual agreements with external laboratories
Price: 8 / 10 USD
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