Standard Operating Procedures

The PCTU follows a number of standard operating procedures (SOPs) from the Barts and The London joint research office.

The relevant SOPs from this office are:

SOP No. 1	Research Grants Application
SOP No. 2	Implementation of New Research Grant
SOP No. 11	Sponsorship for CTIMPs BLT or QMUL
SOP No. 12	Sponsorship for Projects (non-CTIMPs) BLT or QMUL
SOP No. 13	Arranging Indemnity for Research
SOP No. 14	Peer Review
SOP No. 15	QM Research Ethics Committee Application Procedure
SOP No. 16	Data Protection for Research Projects
SOP No. 17	Project Amendments
SOP No. 18	Project Closure – Guidance for Research Staff
SOP No. 20	Archiving
SOP No. 21	Extensions, Progress Reports and Annual Email Reminders
SOP No. 22	Internal Audit Process
SOP No. 24	Initiation and Management of Clinical Trials of Investigational Medicinal Products (CTIMPs)
SOP No. 25	Informed Consent
SOP No. 26	Adverse Event Reporting
SOP No. 27	Reporting Incidents Relating to Research
SOP No. 28	Monitoring of CTIMPs sponsored by BLT or QMUL
SOP No. 33a, b & c	Research Related Complaints
SOP No. 37	Serious Breach of GCP or the Trial Protocol

The PCTU also works with a number of its own SOPs. All PCTU SOPs listed on the PCTU website have been reviewed and authorised by the PCTU director. Access to the SOPs is available on request. If you would like a copy of any of the SOPs listed then please email Naheedah Choudhury.

PCTU 01 - Pragmatic CTU SOPs
PCTU 02 - Protocol Development
PCTU 03 - Trial Master File
PCTU 04 - QA and QC
PCTU 05 - Statistician involvement
PCTU 06 - Randomisation and blinding
PCTU 07 - Statistical analysis
PCTU 08 - Trial Oversight Committees
PCTU 09a - Data Management: Data Collection and Quality Control
PCTU 09b - Data Security
PCTU 09c - Data Management: Data Freeze Handover and Lock
PCTU 10 - IMP Management and Labelling
PCTU 11 - Annual Progress, Safety and End of Trial Report
PCTU 12 - Trial Support Procedure
PCTU 13 - Filtering System for Trial Support Enquiries
PCTU 14 - Document Control