Good Clinical Practice

"Comprehensive Overview of Clinical Trial Regulations in the UK"

Comprehensive Overview of Clinical Trial Regulations in the UK

Clinical Trial Regulations in the UK are designed to ensure the safety, rights, and well-being of participants while maintaining the scientific integrity of research. Governed by key legislation such as the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medicines and Medical Devices Act 2021, and guidelines like Good Clinical Practice (GCP), these regulations provide a robust framework for conducting trials. Regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committees (RECs) oversee trial approvals, safety monitoring, and compliance. By adhering to these regulations, the UK fosters ethical, high-quality research and maintains its position as a leader in global clinical trials.

Comprehensive Overview of Clinical Trial Regulations in the UK Read More »

Standard Operating Procedure (SOP) for Handling of Investigational Products

Standard Operating Procedure (SOP) for Handling of Investigational Products

This comprehensive Standard Operating Procedure (SOP) outlines detailed, step-by-step instructions for the proper handling of Investigational Products (IPs) in clinical research. It covers essential procedures including receipt, storage, inventory management, dispensing, return, and disposal, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Key responsibilities, safety considerations, and training requirements are also addressed to maintain the integrity of clinical trials and participant safety.

Standard Operating Procedure (SOP) for Handling of Investigational Products Read More »

mobile app development. Safety measures at zencore global. Wordpress development services.