This guidance provides the subjects that your site Standard Operating Procedures (SOPs) should cover to ensure you are ready to deliver commercial research.
Within research, it is really important that the right governance is in place to support research at your site. With that in mind, your site should have Standard Operating Procedures available. These SOPs will explain how certain aspects of research should be undertaken at your site. It is essential that you know where your SOPs are and what they contain. Below is a list of the key SOPs that you should expect at a research site.
Process for development and review of Site SOPs
SOP template
Subject recruitment
Informed Consent Process and Documentation
Source documentation and ALCOA+
Electronic Medical Records
IP management
Handling of participant emergencies
AEs and SAEs (capturing, reporting)
Preparation and handling of laboratory samples
Calibration and Maintenance of Site Equipment
Communications (e.g with participants)
Site job descriptions and CVs
Training
Management and archiving of study files
Self-Audit/QC Process
Audit/Inspection Process
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.
It maybe that you are asked to undertake a new research activity that has not be carried out at your site before. In which case, speak to your R&I teams to ensure that there is an agreed process and that a SOP has been written to reflect this before recruitment to the study commences.