Edinburgh Clinical Trials

Governance

The Academic and Clinical Central Office for Research and Development (ACCORD) is a joint office comprising clinical research management staff from NHS Lothian and the University of Edinburgh.

accord website

ACCORD supports researchers to meet stringent research governance and regulatory requirements, and to fulfil legal, ethical and scientific obligations during the conduct of their research. As a single point of entry to professional advice and expert regulatory support, ACCORD has underpinned the institutions’ successful sponsor inspections by the Medicines and Healthcare products Regulatory Agency (MHRA).

Working as part of NHS Research Scotland (NRS), ACCORD offers central access to state-of-the-art clinical research infrastructure that facilitates the delivery of world-class research. It endeavours to provide rapid R&D approval times that meet ambitious national targets and enable prompt and efficient study start up. Its Quality Assurance and Clinical Trial Monitoring team maintain oversight of the research portfolio, acting to ensure that patient welfare is safeguarded, institutional risk is minimised and the highest research standards are upheld. Through ACCORD, NHS Lothian and the University of Edinburgh act as single sponsors or co-sponsors of clinical research led from Lothian.

For ECTU Trial Portfolio studies, ACCORD will delegate defined responsibilities to ECTU

ECTU has a suite of SOPs that cascade from the practices defined by ACCORD SOPsECTU works closely with ACCORD to ensure regulatory compliance and a continuous process of quality improvement.

ACCORD - contact them here

ECTU Policies

Current ECTU Policies

Standard Operating Procedures

We have developed several Standard Operating Procedures and Working Practice Documents to support the running of trials within the unit and to ensure compliance with the principles of Good Clinical Practice (GCP).  Our procedures have been developed according to the specific work groups within ECTU.  

Trial Steering Committees and Data Monitoring Committees

Does your study require a Trial Steering Committee and a Data Monitoring Committee?

Further information:

Clinical Support Trial Management Statistical and Health Economics Support
Data Management Trial Planning