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. Please refer to this flow diagram for additional information on specific aspects of your R&I application

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. A checklist of documents required for R&I approval, and a documentation guide, can be downloaded here:

• R&I Document Checklist
• R&I Documentation Guide

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

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. Details of some of the fixed fees, payment details and wording for the remittance section of the contract can be downloaded here: CTA Finance Template

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. Legal advice on any aspect of the mCTA can be obtained from the CLO. Examples of CTA’s can be found here:

• Contract Research Organisation   
• NHS-ABPI-BIA
• Device Trial

GCP Training:

All members of the research team participating in a clinical trial of any type are required to complete a recognised GCP training course. These courses are run at the Glasgow CRF regularly and are free for NHS GG&C staff members.

In addition, there is a recognised online GCP course that is free to NHS GG&C employees.

A copy of the Board’s GCP training policy can be downloaded here.

Biochemistry SGH CPA Letter of Accreditation

Biochemistry SGH ACC Cert 2013

Haematology SGH CPA Certificate 2013

Haematology SGH CPA Letter 2013

All members of the research team participating in a clinical trial of any type are required to complete a recognised GCP training course. These courses are run at the Glasgow CRF regularly and are free for NHSGGC staff members.

In addition, there is a recognised online GCP course that is free to NHSGGC employees.