This guidance provides the subjects that your site Standard Operating Procedures (SOPs) should cover to ensure you are ready to deliver commercial research.
Process for development and review of Site SOPs
Subject recruitment
Informed Consent Process and Documentation
Source documentation and ALCOA+
Electronic Medical Records
IP management
Handling of participant emergencies
Site job descriptions and CVs
AEs and SAEs (capturing, reporting)
Preparation and handling of laboratory samples
Calibration and Maintenance of Site Equipment
Communications (e.g with participants)
Training
Management and archiving of study files
Self-Audit/QC Process
Audit/Inspection Process
Have an SOP template.
Ensure your SOPs comply with ICH-GCP and clinical trial regulations.
SOPs should reflect the process that is followed.
Don’t forget version control and approver signature/date.
Use your organisation's letterhead.
Schedule timely review dates (every 1-2 years) and include a change log.
SOPs should be readily available to the team as well as study monitors.