Dana Gergely and Beverley Greenhalgh looking at a file

Compliance

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The Compliance Team is part of NCA’s Research and Innovation Management Team and helps to make sure clinical research studies are conducted in line with any applicable regulatory requirements, international standards and NCA policies and procedures.

Adhering to these requirements and NCA policies and procedures, means that the rights and wellbeing of individuals taking part in clinical research are protected and the data collected is credible. Monitoring conduct and delivery throughout a study’s duration ensures compliance with the approved protocol/amendment(s), the applicable regulatory requirements and/or standards and NCA’s policies for designing, conducting, recording, and reporting clinical research that involve human participants.

The Compliance Team also conduct monitoring risk assessments, monitor NCA sponsored studies, audit the Northern Care Alliance Research Collection, audit NCA-hosted studies where necessary and conduct facility audits across NCA, including the Clinical Research Facilities, Clinical Research Pharmacy Facilities, Research Laboratory Facilities. They support Human Tissue Act audits and regulatory inspections.

Compliance reviewers performing monitoring visits and audits are expected to be independent of the activities being reviewed. Where possible, they are expected to report into independent lines of management (that is not to the CI/PI) to make sure issues can be effectively and appropriately managed and escalated where necessary.

Useful links / templates:

Training (nihr.ac.uk)

Research Standards and Guidance (hta.gov.uk)

Research Tissue Banks – new eLearning modules | Events | Human Tissue Authority (hta.gov.uk)

 

For more information regarding research compliance, monitoring and auditing, please contact:

Beverley Greenhalgh – Research and Innovation Compliance Manager

Beverley.Greenhalgh@nca.nhs.uk

 

Dana Gergely – Research and Innovation Compliance Officer

Dana.Gergely@nca.nhs.uk

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