It depends on what you do yourself
Regulators do not set a number. They expect written procedures for every activity you are responsible for as sponsor, and evidence that your team follows them. So the count is driven by your operating model: the more you run in-house, the more procedures you need; the more you delegate, the more your SOPs shift from doing the work to overseeing it.
What a full sponsor set looks like
Our comprehensive library has 29 SOPs, supported by 10 work instructions and 80 forms and templates. They fall into three groups:
- Quality management (13): document control, training, quality events and CAPA, Good Clinical Practice, service provider selection and management, internal and external audit, good documentation practice, hosting audits and inspections, quality system review, risk management, fraud and serious misconduct, and the quality management plan.
- Clinical operations (15): site management and monitoring, oversight of monitoring, investigator and site selection, informed consent templates, deviations and serious breaches, the trial master file, project management, medical monitoring, pharmacovigilance, safety committees, release of investigational product, statistics, data management, translations and medical writing.
- Regulatory (1): regulatory and ethics submissions, including amendments, notifications and end of trial.
Where the number comes down
Several procedures are only needed when you do that work yourself:
- Statistics and data management, when a delegated provider does the work. Your project management and vendor management SOPs then cover the oversight.
- External audit, when you outsource your audit programme.
- Release of investigational product, when monitoring or your IP depot already covers it.
- The quality management plan, when manufacturing QA extends cover to the trial.
A highly outsourced sponsor often ends up nearer 20 procedures than 30.
What never comes down
Some responsibilities stay with the sponsor however much you delegate, and inspectors will ask for the procedures behind them first: document control, training, quality events and CAPA, risk management, vendor selection and oversight, the trial master file, and hosting inspections. See what SOPs a sponsor needs for a highly outsourced trial.
Finding your number
Start by mapping each sponsor activity to who performs it: you, a CRO, or another provider. A GCP gap analysis does this against your current documents and gives you a prioritised list, so you only buy and adopt what you need. Individual SOPs start from £500; a complete pack is up to £15,000.