Newcastle Clinical Trials Unit

SOP Library

Standard Operating Procedures Library

Newcastle Clinical Trials Unit runs studies/trials according to the Standard Operating Procedures below. If you would like access to any of the Standard Operating Procedures please contact the Quality Assurance Team (clinicaltrials.qa@newcastle.ac.uk).

General

  • SOP GE-001-05 Standard Operating Procedures
  • SOP GE-002-03 Confidentiality and Protection of Personal Data
  • SOP GE-003-03 Document Control
  • SOP GE-004-02 Training of NCTU Personnel
  • SOP GE-005-02 NCTU Audit Programme

Data management

  • SOP DM-010-01 Data Management
  • SOP DM-011-01 Database Setup and Maintenance
  • SOP DM-012-01 Release of Data and Database Lock
  • SOP DM-013-01 NCTU Randomisation System

Trial management

  • SOP TM-001-04 Trial Master File & Investigator Site File
  • SOP TM-002-03 Application and Maintenance of a Clinical Authorisation from the Competent Authority
  • SOP TM-003-04 Safety Reporting in CTIMPs and ATMPs
  • SOP TM-004-04 Monitoring a Research Study
  • SOP TM-005-04 Site Selection and Initiation
  • SOP TM-007-02 Participant-Related Documentation
  • SOP TM-008-03 Obtaining and Maintaining a Favourable Opinion of a Research Ethics Committee for Health-Related Research
  • SOP TM-009-04 Clinical Study Report
  • SOP TM-010-03 Protocol Development
  • SOP TM-012-04 Site Closure
  • SOP TM-013-04 Deviations, Violations and Serious Breaches of GCP and/or the Protocol
  • SOP TM-014-02 Urgent Safety Measures
  • SOP TM-015-02 Procedures for Arranging Sponsorship, Contracts, Agreements and Indemnity
  • SOP TM-016-04 End of Study Procedures including Archiving
  • SOP TM-017-03 Pharmacy File
  • SOP TM-018-03 Trial Oversight Committee
  • SOP TM-019-01 Safety Reporting for Medical Device Trials
  • SOP TM-020-02 Risk Assessment of NCTU Studies
  • SOP TM-021-01 Study Drug Supplies
  • SOP TM-022-01 GCP Compliance in Laboratories