SOP library
29 SOPs, ready to adopt.
Every procedure a sponsor needs, with the work instructions and forms that go with them. Take the full pack or only what you need.
29
SOPs
10
Work instructions
80
Forms and templates
From £500
Per individual SOP
The full register
Every document, by reference ID. Filter by type or search for a topic.
Clinical operations
15 of 15Statistics and Data Management are only needed when that work is not delegated to a provider. We tell you which apply.
- CLN-001SOPClinical Site Management & Monitoring
- CLN-002SOPOversight of Monitoring
- CLN-003SOPInvestigator and Site Selection
- CLN-004SOPDevelopment and Review of ICF Template
- CLN-005SOPManagement of Project & Protocol Deviations & Serious Breaches
- CLN-006SOPTrial Master File
- CLN-007SOPClinical Project Management
- CLN-008SOPMedical Monitoring
- CLN-009SOPPharmacovigilance
- CLN-010SOPEssential Documents for IP Release
- CLN-011SOPSafety Related Committees
- CLN-012SOPStatistics
- CLN-013SOPData Management
- CLN-014SOPTranslations
- CLN-015SOPMedical Writing
Quality management
13 of 13- QMS-001SOPManagement of GxP Controlled Documents, Development and Maintenance of SOPs
- QMS-002SOPTraining and Training Record Documentation
- QMS-003SOPQuality Events and CAPA Management
- QMS-004SOPGood Clinical Practices
- QMS-005SOPService Provider Selection and Management
- QMS-006SOPInternal Audit Program
- QMS-007SOPExternal Audit Program
- QMS-008SOPGood Documentation Practices
- QMS-009SOPHosting Sponsor Audits and Regulatory Authority Inspections
- QMS-010SOPQuality System Review Meetings
- QMS-011SOPRisk Management
- QMS-012SOPReporting Suspected or Confirmed Fraud, Serious Misconduct or Noncompliance
- QMS-013SOPQuality Management and Quality Management Plan
Regulatory
1 of 1- REG-001SOPRegulatory and Ethics Submission
Work instructions
10 of 10Step-by-step detail behind the monitoring and trial master file procedures.
- CLN-001-WI-01WISite Initiation Visits (SIV)
- CLN-001-WI-02WIInterim Monitoring Visits (IMV)
- CLN-001-WI-03WIClose-Out Visits (COV)
- CLN-002-WI-01WIClinical Monitoring Plan Development
- CLN-002-WI-02WIQuality Control Oversight Monitoring Visits (OMV)
- CLN-003-WI-01WISite Qualification Visits (SQV)
- CLN-006-WI-01WITMF/eTMF Setup and Planning
- CLN-006-WI-02WIDocument Collection and Processing
- CLN-006-WI-03WITMF/eTMF Oversight and Inspection Readiness
- CLN-006-WI-04WITMF/eTMF Closeout and Archival
Plus 80 forms and templates
The records each procedure produces, ready to use.
- SIV, IMV and close-out visit report templates
- Clinical monitoring plan template
- Protocol deviations tracking log
- Serious breach evaluation form
- TMF index and TMF plan templates
- Training matrix and training log
- Quality event and CAPA log
- Risk assessment tool
- Audit plan, agenda and report templates
- Ethics and regulatory submission checklist
Need a few SOPs, or the whole pack?
From £500 for an individual SOP, up to £15,000 for a complete pack. Tell us about your trial and we'll quote for exactly what you need.
A reply from a person, usually within one business day.