Standard Operating Procedures (SOPs)

These are the current standard operating procedures (SOPs) that are being used within PRIMENT CTU. A SOP Working Group meet on a monthly basis to review the current versions while discussing the need for any new SOPs.

Current Standard Operating Procedures:

PRM-SOP-001	SOP for SOPS
PRM-SOP-002	Risk Assessment
PRM-SOP-003	Document Version Control
PRM-SOP-004	Protocol Development
PRM-SOP-005	Site Initiation
PRM-SOP-006	Non-Compliance to Study Protocol, Regulatory Requirements and Serious Breaches of GCP or Trial Protocol
PRM-SOP-007	Statistics
PRM-SOP-008	Investigator Pharmacovigilance
PRM-SOP-009	Development Safety Update Report
PRM-SOP-010	CTU Pharmacovigilance
PRM-SOP-011	Essential Documentation and the Preparation and Maintenance of Trial Master Files
PRM-SOP-013	Urgent Safety Measures
PRM-SOP-014	Clinical Trial Monitoring
PRM-SOP-015	IMP Labelling
PRM-SOP-016	Randomisation, Blinding and Code Breaking
PRM-SOP-017	IMP Destruction, Return and Recall
PRM-SOP-018	Validating Sealed Envelope Systems
PRM-SOP-019	Data Handling
PRM-SOP-020	Change Control for Sealed Envelope Systems
PRM-SOP-021	Obtaining Informed Consent
PRM-SOP-022	Non-CTIMP Safety Management
PRM-SOP-023	MHRA, Ethics and HRA Approvals
PRM-SOP-024	Development, Review and Approval of Case Report Forms
PRM-SOP-025	Managing Personal Data
PRM-SOP-026	Database Lock, Unlock and Closure
PRM-SOP-027	Amendments
PRM-SOP-028	IMP Logistics
PRM-SOP-029	Study and Trial Closure
PRM-SOP-030	Site Closure
PRM-SOP-031	Archiving
PRM-SOP-032	Health Economics
PRM-SOP-033	IMP Forecasting & Tendering

These SOPs are available to Chief Investigators conducting research with PRIMENT CTU. Please contact us if you wish to collaborate.