Standard Operating Procedures

Level
Advanced

Aims
To explore how an organisation conducting and/or sponsoring clinical trials can develop and integrate Standard Operating Procedures (SOPs) and quality systems in line with The Medicines For Human Use (Clinical Trials) Regulations and the Research Governance Framework (Version 2)

Learning Outcomes
Following the course, participants will be able to:

• Understand the differences between policies, SOPs and work instructions
• Understand why SOPs and controlled documents are important in a quality management system
• Be aware of the content and format of an SOP and more confident when attempting to write one
• Be aware of the common findings relating to SOPs arising from audits and Inspections
• Understand the concepts relating to the management of SOPs
• Understand the issues surrounding SOP training, disseninationa and archiving

Programme
The course will cover the following topics:

• Standard Operating procedures in Clinical Research
• Clinical research activities
• SOPs as part of a quality management programme
• SOP Dissemination, Retrieval and Archiving
• SOP Training Strategies

Further Information
The Medicines for Human Use (Clinical Trials) Regulations have transposed the EU Directive into UK law. Through a mixture of workshop and presentation sessions, this course is designed to help organisations identify and integrate appropriate and compliant SOPs focusing on issues relating to documentation management and quality assurance

Duration
This is a one day course

Cancellation Policy
UKCRN courses are offered free of charge to all staff and public and patient representatives working on or associated with the UKCRN portfolio of studies. Networks and host organisations are expected to pay travel, accommodation and other additional expenses incurred by their nominated staff. Failure to take up a pre-booked, confirmed place without giving the necessary notice will incur a £75.00 charge to cover part of the UKCRN Coordinating Centre’s costs. By accepting enrolment on this course, the UKCRN will determine that you are fully aware of the booking and cancellation/non-completion policies, and agree to the terms and conditions contained within these documents