Standard Operating Procedures (SOP) and Polices
Our SOPs provide guidance for researchers conducting studies within King’s Health Partners. This includes key contact information, requirements for following the correct SOP and our SOP documents.
Standard Operating Procedures (SOP)
Our suite of Standard Operating Procedures (SOPs) and policies provides the quality framework required by the Medicines for Human Use (Clinical Trials) Regulations, ensuring all trials within King’s Health Partners (KHP) are conducted to the highest standards of quality, safety, and compliance.Â
- All clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations (GSTT, KCH (including PRUH), SLaM, or KCL (including IoPPN) must be conducted in accordance with this suite of SOPs.Â
- For externally sponsored trials, the sponsor’s SOPs should be followed. Where procedures are not otherwise defined, the KHP-CTO SOPs may be used.
Document controlÂ
Version control ensures that only the most current, approved documents are used in clinical research:Â
- All SOPs are controlled documents and must be routinely reviewed and updated. You should always refer to the online versions to ensure you are working from the latest document, rather than relying on a downloaded copy.Â
- All documents produced by the KHP-CTO must be version controlled. This includes (but is not limited to): SOPs, templates, and training presentations.Â
- Investigator sites should also apply version control to key study documents such as trial protocols, Participant Information Sheets (PIS) and consent forms, and Case Report Forms (CRFs).
ComplianceÂ
- All SOPs in this library are designed to ensure compliance with UK Clinical Trials Regulations and GCP.
- Compliance with these documents will be monitored by the KHP-CTO Quality Team, through audit, monitoring, and inspection readiness activities.
Our Standard Operating Procedures (SOP)
Our current King’s Health Partners Clinical Trials Office SOPs provide guidance on the processes required for conducting clinical research across King’s Health Partners.
The SOPs below are the current versions. If you require an older version please contact your Clinical Research Associate.
1, Production, Approval and Review of SOPs
This document describes the process for writing, approving, implementing, and reviewing Standard Operating Procedures (SOPs) within the King’s Health Partners Clinical Trials Office (KHP-CTO).
2. Clinical Trials Training
This document describes the process for ensuring that all staff involved in clinical trials are qualified by education, training, and experience to perform their tasks.
3. Clinical Trial Monitoring
Monitoring is an integral part of the quality control of a clinical trial and verifies the ongoing quality of the study.
4. Archiving of Clinical Trial Data
Defined local procedures for preparing clinical study records at an investigational site.
5. Trial Master File
How to file and manage essential clinical trial documents in an orderly, timely way, in line with Good Clinical Practice.
6. Notification of a Serious Breach
The process for notification of serious breaches of Good Clinical Practice or the approved trial protocol.
7. Obtaining Informed Consent for Clinical Trials
Obtaining written informed consent from a participant in a Clinical Trial of an Investigational Medicinal Product (CTIMP) study.
8. Case Report Form (CRF) Design
Procedures to be followed when designing and developing CRFs for use within a clinical trial.
9. Writing a GCP Compliant Protocol
Outlines the format for writing a research protocol in accordance with Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trials) Regulations.
10. The Investigator Brochure (IB)
When is an IB is required, the minimum content needed and when to update the IB.
11. Clinical Trial Insurance (KCL Employed Investigators)
Insurance or indemnity provisions to cover the liability of the investigator and sponsor in relation to a clinical trial.
12. Application and Maintenance of a Clinical Trial Authorisation (CTA)
Procedures for applying for and maintaining a CTA.
13. Initiation of an Investigator Site
Integral to the quality control of a clinical trial, designed to ensure quality and accurate documentation of the trial
14. Emergency Code Break In Clinical Trials
The process for emergency code break (unblinding) of treatment within KHP clinical trials
15. Clinical Trial Computer System Validation
Documented assurance of the integrity and validity of computer system, meeting the fundamental requirement of Good Clinical Practice.
16. Investigator Site Close Out Procedures
Close-out procedures for clinical trials monitored by KHPCTO
17. Development Safety Update Reports (DSURs)
How to prepare and submit the internationally recognised annual safety report.
18, Data Management in Clinical Trials
The importance of data management and standards required.
19. Lab: Procedures and Sample Analysis in Clinical Trials
The oversight required for samples taken for protocol endpoint analysis in clinical trials.
20. Lab: Sample Management in Clinical Trials
Managing laboratory samples collected for protocol endpoint analysis in clinical trials.
21. Vendor Selection and Oversight
The process for selecting and overseeing vendors involved in clinical trials.
POLICY: Pharmacovigilance and Safety Reporting
Requirements for the recording and reporting of adverse medical effect clinical trial patients.
POLICY: Pandemic Contingency Plan
Plans to ensure responsibilities continue to be met for ongoing trials.Â
POLICY: Quality Policy
A unified framework to ensure that all trials across King’s Health Partners are managed to the same high standards.