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