The core areas
Whatever the trial, a sponsor's procedures need to cover:
- Quality management: document control, training, quality events and CAPA, risk management, and internal audit.
- Trial oversight: project management, and oversight of any activity you delegate.
- Vendor management: how you select, qualify, contract and oversee CROs and other providers.
- Sites and monitoring: investigator and site selection, site management, monitoring, and oversight of monitoring.
- Safety: medical monitoring, pharmacovigilance and safety committees.
- Data: data management and statistics, or oversight of the providers who do them.
- Documents and records: the trial master file, informed consent templates and archiving.
- Deviations: protocol deviations and serious breaches.
- Regulatory: ethics and regulatory submissions, amendments and end of trial notifications.
- Inspection readiness: hosting sponsor audits and regulatory inspections.
What shapes the exact set
- Trial type: a medicines trial carries different safety and IP obligations to a medical device investigation.
- Phase and complexity: first-in-human and multi-country trials need more safety and translation procedures.
- How much you outsource: delegating shifts procedures from doing to overseeing. See SOPs for highly outsourced trials.
- Where you run: procedures written for UK requirements can be adapted for other regions. See SOPs outside the UK.
What inspectors check
Having SOPs is not enough. Inspectors look for procedures that are current and under version control, staff trained on them before doing the work, and records showing the procedures were actually followed. A procedure nobody follows is a finding in itself.
Getting a complete set
Our SOP library lists every procedure by name, with the work instructions and forms that go with them. For the numbers involved, see how many SOPs a sponsor actually needs.