CPTU Standard Operating Procedures

Before you can download an SOP you should first register using your email address. You will then be sent a link to the downloadable files.

Note, we do keep a record of your email address, organisation and SOPs downloaded. We only use this information for our own reporting and we will not share this information with any third party.

Proceed to SOP registration.

• Information Technology
  • Application Documentation v2
  • Application Programming v2
  • Backup and Disaster Recovery v2
  • Case Report Form Acceptance Tests v2
  • Case Report Form Design and Development v2
  • Case Report Form Versioning v2
  • Managing Trial Database Access v2
  • Managing Trial Website Access v2
• Quality Assurance
  • CPTU Training and Staff Files v2
  • Creating and Revising SOPs v2
  • Document Control v1
  • Set Up and Internal Audit of a Quality Management System v3
• Statistics
  • Statistical Analysis Plan v2
• Trial Closure
  • Archiving for CPTU and Trial Site Staff v2
  • Clinical Trial Report for CTIMPs v2
  • End of Trial Declaration for CTIMPs v2
  • Trial Site Closure v3
• Trial Management
  • Data Management v2
  • Data Monitoring Committees v2
  • Informed Consent Procedures v4
  • Long-Term Follow-Up: Flagging of Study Participants in England, Wales, & Scotland v4
  • Pharmacovigilance for CTIMPs - Investigator Responsibilities v2
• Trial Setup
  • Essential Documents and the Investigator File v2
  • Essential Documents and the Trial Master File v2
  • IMP Management and Accountability v2
  • Participant Allocation - Randomisation - Sponsor Responsibilities v2
  • Producing Patient Information Sheets and Consent Forms v3
  • Protocol Development for CTIMPs v2
  • Risk Assessment: Trial Management and Monitoring v2
  • Trial Site Initiation v2