NHSGGC supports the conduct of high-quality commercially Sponsored and Funded research, which allows patient the opportunity to access novel medicines. NHS GG&C currently has the highest volume of Commercial research in Scotland
To find the appropriate contact in the R&I Commercial Team for your study, please use the Info Path document available here.
You can also find contact details for the Commercial Team here
All multicentre clinical, health and social care Research and Innovation studies in Scotland require to be submitted to the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) at gram.nrspcc@nhs.scot NRSPCC will upload multicentre studies onto the shared Scottish R&D web based database and make them available to participating Health Boards for review and approval and will ensure single centre studies are available to the relevant R&D office.
The following links offer more information on the Commercial research approval process in NHS GG&C:
Commercial Team Contact Information
Study Type
All study types
Disease Area
Haematology (Oncology only) Medical Genetics Oncology Pathology
Commercial Co-ordinator
Dr George Bakirtzis – Commercial Research Co-ordinator
George.Bakirtzis@ggc.scot.nhs.uk
0141 314 0225
Administrative Support
Ms Shanice Thomas – Research Administrator
Shanice.Thomas@ggc.scot.nhs.uk
Randdsystems.PF1@ggc.scot.nhs.uk
0141 314 0229
Line Manager: Dr George Bakirtzis
COPY DETAILS BELOW INTO SAME FORMAT AS ABOVE
Study Type | Disease Area | Commercial Co-ordinator | Administrative Support |
All study types | Cardiology Cardiovascular & Exercise Medicine Diabetes Gastroenterology Haematology (Non Oncology) Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy) Haepatology Infectious Diseases (Includes Infectious Diseases, Microbiology, Virology and Bacteriology) Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition) Orthopaedics Public Health (Includes Occupational Health, Sexual Health and Family Planning) Physiotherapy Renal and Urology Rheumatology Respiratory Medicine Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery) | Mr Ross Nicol Commercial Research Co-ordinator Ross.nicol@ggc.scot.nhs.uk 0141 314 0221 | Ms Oumaima Abakar Ismail Research Administrator oumaima.abakarismail@ggc.scot.nhs.uk 0141 314 0217 Line Manager: Mr Ross Nicol |
All study types | A&E, Injuries and Emergencies Anaesthetics Critical Care Dermatology Ear, Nose and Throat (ENT) Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability) Neurology (Non Stroke) (Includes Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache) Paediatrics Obstetrics, Gynaecology and Midwifery Ophthalmology Oral and Dental Health (Includes Oral Medicine, Dentistry/Community Dentistry and Dentistry – Restorative) Stroke | Mrs Ruth Pink Commercial Research Co-ordinator Ruth.pink@ggc.scot.nhs.uk 0141 314 0217 | Ms Natalie Phillips Research Administrator Natalie.phillips@ggc.scot.nhs.uk 0141 314 0216 Line Manager: Mrs Ruth Pink |
Governance of Commercial Research
Application Flow
NHS GG&C has responsibility to ensure that there are appropriate governance arrangements in place for any commercially funded research, thus ensuring that:
- The interests and safety of patients enrolled in trials are protected in all eventualities
- All trials are fully costed and that the costs are properly recovered
- Maximum benefit is provided to the investigator and to the board
- The interests of both the investigator and the board are protected in the event of Intellectual Property arising out of research
- Any external regulatory, ethical and financial approvals are obtained
- Any risks (liabilities) are properly considered and minimised
- The board presents a thoroughly professional approach in its dealings with industry.
In order to ensure Governance of commercial projects, all studies must receive Management approval. Only protocols and trials approved by the R&I Management Office will be covered by the appropriate insurance or NHS indemnity arrangements and the Board will not accept liability for any activity that has not been approved. This website contains a practical guide to help you navigate the R&I process and highlights key steps required to get your research project up and running
Initial R&I Contact and Document Request
Investigators
If you have been approached to participate in a commercial research study your first port of call should be your Research Co-ordinator. The Co-ordinator will be able to advise on the steps required to get up and running, and will take over negotiations over fees and contracts with the company concerned. With your help the Co-ordinator should be able to manage the approval process from start to finish.
Companies
If you would like to run a study within NHS GG&C please contact the relevant Research Co-ordinator who will be able to advise on the best way to submit an R&I application.
Documents
In order to gain R&I approval as quickly as possible, we advise that you submit to R&I as early as possible. We are happy to receive documents as they become available, this will allow us to look at your application and progress quickly. The very minimum we require to start our process is a copy of the protocol and proposed budget.
Engage Support Departments
Once we have identified what support departments will be involved in the study we can contact the relevant personnel for confirmation of costs and approval for research to be conducted within the department
Project Costing
Once a copy of the protocol has been submitted to R&I the Research Co-ordinator can begin costing the project. Costs associated with a research project are calculated on the staff time required and on the allocated price for procedures. The Research Co-ordinator will usually work closely with the research team to ensure that time required to complete the study is accurately captured. The project costing is then sent to R&I finance and the investigator for approval. If required, the Research Co-ordinator can negotiate fees with the commercial company
Commercial Contracts and Agreements
Before any commercial study can proceed within NHS GG&C a written agreement between the Board and the commercial company should be signed by both parties. Contracts should only be negotiated by Research Co-ordinators and are signed by an R&I director. The agreement should define the following:
- Scope of work
- Acceptable payment arrangements
- Important issues such as the right to publish results
- Protection of confidential information
- Indemnification of third parties.
To help facilitate timely completion of the appropriate contractual documentation, the Association of British Pharmaceutical Industry (ABPI) and the Department of Health have developed, and published, a model Clinical Trials Agreement (mCTA) as a standard contractual framework for commercial trials involving NHS patients. To incorporate slight differences in Scottish Law and policy, a revised mCTA for use in Scotland has been developed. All legal agreements between the Board and commercial companies should be governed by the laws of Scotland.