Standard Operating Procedures

External Researcher Documents
The South Eastern Health and Social Care Trust have approved a number of documents to ensure that clinical research is conducted and reported in accordance with the principles of GCP, regulatory requirements and the Research Governance Framework.

Please ensure you are working to the current versions of these documents by visiting this page frequently.

Standard Operating Procedures

Click on the SOP below to view.

SOP01- Creation, Review and Management of SOP's
SOP02- Recording, Managing and Reporting Adverse Events
SOP03- Archiving Study Documents
SOP04- Authorship in Research
SOP05- Case Report Forms
SOP06- Routine Project Audit
SOP07- Computerised Systems for Clinical Trials
SOP08- Data Collection and Storage
SOP09- Data Management
SOP11- Delegation of Responsibilities
SOP12- Equipment Maintenance
SOP13- Essential Documentation and the Creation and Maintenance of Trial Master Files
SOP14- For-Cause Project Audit
SOP15- GCP Inspection Procedures (MHRA)
SOP16- Submitting a CTA application to the MHRA
SOP17- How to Submit a Clinical Investigation for a Non EC Marked Device or a CE Marked Device
SOP18- IMP
SOP19- Informed Consent for Research
SOP20- Maintaining Training Records
SOP21- Making a Valid Application to a Research Ethics Committee
SOP22- Notification of End of Study
SOP23- Notification of Serious Breaches of GCP
SOP24- Sponsorship and Indemnity
SOP25- Maintaining a Site File
SOP26- Monitoring Clinical Trials
SOP27- Managing Research Participant Complaints
SOP28- Booking Research Specimens
SOP29- HTA Disposal of Human Tissue
SOP30- Human Tissue Act Training for Designated Individuals and Those Under Their Direction
SOP31- HTA SEHSCT Quality Management of Human Tissue Policy Statement
SOP32- HTA Incident Reporting Form
SOP33- Risk Assessment
SOP34- Creation and Maintenance of an Investigator Brochure
SOP35- Randomisation, Blinding and Emergency Unblinding

If you experience any problems when downloading SOPs or associated documents, or have any comments, please contact us:

Telephone : 028 9055 3101
E-Mail : research.development@setrust.hscni.net