Standard Operating Procedures Library | Newcastle Clinical Trials Unit

Please expand on the title-bars for a list of NCTU SOPs. For further information regarding our SOPs please contact our Quality Assurance Team.

General

SOP GE-001-07 Standard Operating Procedures

SOP GE-002-04 Confidentiality and Protection of Personal Data

SOP GE-003-04 Document Control

SOP GE-004-06 Training of NCTU Personnel

SOP GE-005-05 NCTU Audit Programme

STAT SOP-001-04 Statistical Procedures for Clinical Research Studies

Data Management

SOP DM 010-03 Data Management

SOP DM-011-03 Datebase Setup and Maintenance

SOP DM-012-03 Document Control

SOP DM-014-01 Randomisation

Trial Management

SOP TM-001-05 Trial Master File & Investigator Site File

SOP TM-002-06 Application and Maintenance of a Clinical Trial Authorisation from the Competent Authority

SOP TM-003-07 Safety Reporting in CTIMPs and ATMPs

SOP TM-004-06 Monitoring a Research Study

SOP TM-005-06 Site Selection and Initiation

SOP TM-007-03 Participant-Related Documentation

SOP TM-008-05 Obtaining and Maintaining a Favourable Opinion of a Research Ethics Committee for Health-related Research

SOP TM-009-05 Clinical Study Report

SOP TM-010-04 Protocol Development

SOP TM-012-05 Site Closure

SOP TM-013-06 Deviations, Violations and Serious Breaches of GCP and/or the Protocol

SOP TM-014-04 Urgent Safety Measures

SOP TM-015-03 Procedures for Arranging Sponsorship, Contracts/Agreements and Indemnity

SOP TM-016-05 End of Study Procedures including Archiving

SOP TM-017-05 Pharmacy Clinical Trial File

SOP TM-018-04 Trial Oversight Committee

SOP TM-019-03 Safety Reporting for Medical Device Trials

SOP TM-020-04 Risk Assessment of NCTU Studies

SOP TM-021-03 Study Drug Supplies

SOP TM-022-02 GCP Compliance in Laboratories

SOP TM-023-02 Study Responsibilities and Delegation of Duties

SOP TM-024-01 Safety Reporting in Non-CTIMPs