Staff & Recruitment

On the 20th of October the HRA have announced a partnership with ISRCTN, which will enable automatic registration of clinical trials. 

Registering studies before the first participant is recruited is one of the pillars of research transparency, it reduces research waste and prevents duplication. A key commitment they make in the Make it Public strategy is to register trials on behalf of sponsors. The aim is to ease the burden on sponsors and help to make transparency easy and the norm.

Pharmacy services in NHSGGC work in tandem with the Research and Innovation (R&I) department, reviewing all clinical trials to ensure the appropriate standards for conducting research involving medicines are met and also that the study is clinically appropriate and operationally viable. As part of the review process, the Portfolio Pharmacy Clinical Trials Team will liaise with fellow staff e.g. Quality Assurance, Aseptic Services, Clinical Pharmacists and Lead Directorate Pharmacists, whereupon satisfactory completion of the review, Pharmacy approval is given and forms part of the R&I management approval process.   Where NHSGGC are sponsor or co-sponsor for a clinical trial, Pharmacy will assist you from the very early stages of preparing your protocol, assisting you with your medicines related aspects of regulatory applications and setting up your study. Pharmacy can also help prepare the necessary documentation and assist you with IMP management processes at all stages from receipt into Pharmacy to administration to the patient.   For all other clinical trials, Pharmacy work to facilitate multi-site clinical trials as a single working stream and provide information and training to you and your study Team to ensure the trial meets the appropriate standards. We also have close links with Pharmacy clinical trial colleagues throughout Scotland via the Clinical Trial Special Interest Group (CTSIG), sharing best practices in developing our service.   A very visible part of the Pharmacy contribution to clinical trials and research is in the dispensing of medicines to patients or study subjects. Pharmacy work to Standard Operating Procedures (SOPs) and have processes in place to deal with problems such as temperature deviations or medicine defects. Medicines are generally dispensed from the local hospital pharmacy where the patient is attending for their study visits.   All Pharmacy sites in NHSGGC currently provide or have the potential to provide local services to support research.  

R&I work closely with Pharmacy to ensure you are given the best advice.

To help ensure your trial receives Pharmacy approval as quickly as possible, you should approach R&I and Pharmacy in the early planning stages.  Often there is a site selection process by the Sponsor and the Pharmacy Team should be included in that process.   Pharmacy staff will often need to ask some follow-up questions and it is very helpful if researchers keep in contact with Pharmacy staff and update them on their progress and proposed start dates.

A system of single pharmacy review and approval is in development for multi-site clinical trials within NHSGGC. If you are aware your study is going to run over two or more sites, you should contact the R&I-Pharmacy Pharmacy Project Officer/Facilitator in the first instance. 

The first point of call should be your local site Portfolio Pharmacy Clinical Trials Team contact, alternatively you can contact the R&I Pharmacy Team if you have a general query.

Pharmacy work with R&I Finance to cost of the Pharmacy service undertaking a research project, using nationally agreed costs and processes. Pharmacy Clinical Trials Services are required to charge for their involvement in all commercial clinical trials.  Similarly there are costs for participating in non-commercial research – also cited as per nationally agreed process using AcORD.  Depending on the design of non-commercial research, some Pharmacy support services may be free-of-charge to researchers undertaking non-commercial research.  

Pharmacy should receive notification of protocol amendments for hosted trials by R&I and the Sponsor, however, investigators are responsible for ensuring all relevant staff have access to the correct study protocol. It would be helpful if you verified this with the local Pharmacy site. If you need advice relating to the potential impact of your amendment on Pharmacy, you should contact your site Portfolio Pharmacy Clinical Trials Team or the R&I Pharmacy Project Officer/Facilitator if your clinical trial involves multiple sites. 

The Pharmacy Clinical Trial Teams throughout NHSGGC are composed from a mix of Pharmacists, Pharmacy Technicians, Pharmacy Support Workers and a Pharmacy Project Officer/Facilitator.  In addition to each staff group’s professional and vocational qualifications, all Pharmacy clinical trial staff undergo regular Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) training.  Many of our staff have significant experience of working within research and clinical trials over several years. 

The R&I Sponsor Pharmacy Team are based in the R&I Management Office in the grounds of Dykebar Hospital. This team forms the central hub of communication between R&I and the wider Portfolio Pharmacy Clinical Trials service. Communication is also conducted directly between R&I and the Pharmacy sites in acute hospitals as necessary.

IIt is helpful if you let Pharmacy know when you are planning to stop recruiting new patients and/or when patients have completed active treatment involving medicines. This can help Pharmacy ensure they have sufficient supplies to the end of the study in the most cost-effective way. It is standard practice for the Pharmacy file to be archived with the investigators file and arrangements will need to be made with your local Portfolio Pharmacy Clinical Trials Team.

If you are planning a new clinical trial or research where medicines are used then you should contact the relevant R&I Co-ordinator in the first instance. The co-ordinator will then alert the R&I Sponsor Pharmacy Team who will work with you to develop the IMP management processes for your clinical trial and liaise with the relevant site Portfolio Pharmacy Teams that may host the research within NHSGGC.

IMP stands for Investigational Medicinal Product and is the special term used for medicines when they are studied as part of a clinical trial or used as part of a study protocol. Any medicines used within a clinical trial or research study must be of an appropriate quality and this is governed by UK/EU legislation. A key role of Pharmacy is to ensure the medicines used within research are always of a suitable standard for administration to study subjects. 

Pharmacy reviews all hosted clinical trials and research studies where medicines are used. This will ensure the proposed study meets standards around the management of medicines in research e.g. they are the appropriate quality, and the study meets the requirements of NHS GG&C Safe and Secure Handling of Medicines Policy.

Yes, R&I Sponsor Pharmacy will work closely with R&I to assist you with the design and IMP related aspects of your protocol.   We will be involved from grant application to close out of your research project.  We will provide costs in relation to the medicines and pharmacy aspects of the trial for inclusion in the grant.  This will include the pharmacy costs for participating sites, as per ACoRD.  Real costs incurred such as manufacturing costs and the cost of additional medicines over standard care need to be met out of the study funding and these will be provided for inclusion in the grant application.   In addition, we will provide IMP Management documents,  prescription forms, accountability logs and any other documents required to ensure the safe handling and administration of medicines in projects sponsored or co-sponsored by NHSGGC.  We will provide support in relation to the medicine to participating sites and to the trial management group for the life of the research project.

The R&I Sponsor Pharmacy Team will be able to assist you with sourcing IMPs and any other medicines that may be required for your research.   There may be option to use NHS licensed manufacturing units, but R&I Sponsor Pharmacy will advise you on potential contractors to deliver the medicines required for your project. 

If the clinical trial is to be run at only one site within NHSGGC, you should contact the site Pharmacy as soon as possible. However, Pharmacy will not undertake a formal review for approval or begin setting up your study until notified by R&I.   If the clinical trial is to be run over two or more sites within NHSGGC, contact the R&I-Pharmacy Team as soon as possible. 

• Clinical Director:
• Manager: Lynn Prentice
• Lead Nurse: Karen Duffy
• Education, Training & Quality Lead: Naomi Hickey
• Lead Research Radiographer: Tracey Hopkins
• Project Management Unit Lead: Lynsey Gillespie

For more information visit our webpages on the NHS Research Scotland website or email us Glasgow.crf@ggc.scot.nhs.uk and follow us on twitter @GlasgowCRF

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.

Once R&I approval has been issued NHS GG&C has responsibility for:

• Ensuring investigators perform pharmacovigilance to required regulatory timelines as dictated by government legislation (CTIMPS only)
• Ensuring research teams are working to GCP standards as required by the EU Directive and Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (CTIMPS only)
• Following the trial to completion and ensuring regulatory requirements are met for the termination and final reports are submitted to ethics and/or the regulatory authority
• Capturing publication and dissemination, service benefits and other key research outputs

Multi-site Studies Where a research study is being extended to sites outwith GG&C to other NHS organisations, R&I will generate multi-site agreements which set out the responsibility of each party. R&I regularly organise international trials which have global sites round the world, e.g. U.S.A, Australia, France and Japan.

Monitoring R&I has a responsibility to monitor research studies conducted on its premises under ICH-GCP, the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended).

The Investigator is responsible for the conduct of the research study. As a condition of Management Approval the following information is required to be submitted to R&I during the lifespan of the project:

• Notification of the commencement of recruitment at site
• Change of Principal Investigator
• Change of staff or site from the original SSI form
• Amendments – substantial or non-substantial
• SUSARS at site as defined by the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (CTIMPS only)
• Notification of any potential GCP breaches at site as defined by the Medicines for Human Use (Clinical Trials) Regulations, 2006 No. 1928 (CTIMPS only)
• Notification of any regulatory site inspections (CTIMPS only)
• Notification of trial end including final recruitment figures and archiving arrangements.

Investigator Site File All research studies must have a site file to aid in document storage and management of the research study. The site file should contain all essential documents required to be stored at site and retained for five years following the study end (CTIMPS only). Please download an Investigator Site File template here.

Progress Reports The Chief Investigator (CI) must submit an annual progress report each year to Ethics. More information can be found at National Research Ethics Committee (NRES). R&I must also be supplied with a copy of the report made to ethics and the Principal Investigator (PI) must inform R&I when the study ends.

Safety SAE Reporting (CTIMPS only) CTIMPS sponsored by NHS GG&C or co-sponsored with The University of Glasgow The PI should ensure that all members of the research team are familiar with GCTU SOPs for Pharmacovigilance available here.  Further information on the SAE/SUSAR reporting procedure and services provided by the PV office including assistance with the preparation and submission of Annual Safety Reports are available here.

CTIMPs hosted by NHS GG&C Adverse events must be recorded, assessed and reported as specified in the study protocol. SUSAR Reports and Annual Safety Reports must be provided to R&I as per the conditions of Management Approval. Further information available here

Safety Reporting (Research other than CTIMPs) The NRES has specific reporting requirements for safety reporting in research other than CTIMPs. Details are available here

Amendments made to any study specific documentation must be reported to ethics, the MHRA (if the research study is a CTIMP or medical device) and R&I. The NRES require changes to studies to be reported with those deemed substantial to be approved. Guidance on whether an amendment is substantial or non-substantial can be found here. Please submit the following documentation to R&I to ensure management Approval of your study is still valid:

• Copy of the Notification of Amendment form sent to ethics
• Copy of the favourable opinion of the amendment from ethics
• Copies of all documentation listed in the amendment favourable opinion letter received from ethics
• Copy of amendment approval letter from the MHRA (only required for CTIMP or medical device).

Once the above documents have been satisfactorily reviewed by R&I you will receive an email confirming R&I Approval is still valid

Research is defined as: ‘..an attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’ As R&I approval is required for all research studies it is important to know if your project can be classed as research or not. 

• Research must be systematic and follow a series of predefined steps defined in a protocol 
• Research must be well organised and undergo rigorous planning, including performing an in-depth literature review and evaluation of questions to be answered 
• The scientific definition of research generally states that a variable must be manipulated, although case studies and purely observational science do not always comply with this. 

This table should help you decide if your project is research. Should you be unsure, please do not hesitate to contact the R&I office who will be happy to advise. For projects classed as clinical audit or service evaluation, the clinical effectiveness team can provide specialist support and advice.

Data Handling Measures

Interim data handling procedures can be found here

Study protocols, patient information leaflets and patient consent forms should be prepared in standard templates (below) and should be date and version controlled.

When developing your protocol click here for a few key elements that you should consider

Once you have developed a full draft of your Protocol, Patient Information Sheets, Consent Forms and IRAS forms you should ask your Research Co-ordinator to review and provide some comments. Co-ordinators can advise on the level of detail required in each of the documents and can check for consistency between them.

The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage, monitor and finance a study. For any health research study covered by the Research Governance Framework, it is for the sponsor to be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing. For any research that takes place in the context of the NHS in Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for particular aspects of the arrangements for the study. The sponsor may be the Chief Investigator’s employing organisation, the lead organisation providing healthcare, or the main funder. NHS GG&C can act as sponsor in the following situations:

• A study where the CI is an NHS GG&C employee
• A study involving NHS GG&C patients, staff or resources.

For more information on study sponsorship, please contact your Research Co‑ordinator.

Clinical Trials

For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution, company or organisation) who takes responsibility for the initiation management and financing (or arranging the financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials) Regulations 2004. Following appropriate risk assessment, NHS GG&G may act as sponsor on a trial where the Chief Investigator is an employee of NHS GG&C. Where the Chief Investigator is an employee of the University of Glasgow, NHS GG&C and the University may act as co-sponsor. Clinical trials sponsored by NHS GG&C should be formally adopted by and run by standards outlined by the Glasgow Clinical Trials Unit (CTU) standard operating procedures (SOPs).

The Greater Glasgow Health Board Policy on the Management of Intellectual Property can be found here

Pharmacovigilance ensures the safety, quality and efficacy of medicines and healthcare products. The Scottish Executive Health Department Research Governance Framework for Health and Community Care (Second Edition, 2006) further defines the responsibilities in clinical trials and in other research carried out in Scotland. In CTIMPs sponsored by NHS Greater Glasgow and Clyde or co-sponsored with the University of Glasgow, the delivery of pharmacovigilance activity within the CTIMP is delegated to the Chief Investigator (CI). However, the ultimate responsibility and accountability for pharmacovigilance remains with the sponsor.  The Pharmacovigilance Office facilitates and ensures compliance with this responsibility and provides central coordination of pharmacovigilance activity within the Glasgow Clinical Trials Unit.

Pharmacovigilance Office

Glasgow Clinical Trials Unit Robertson

Centre for Biostatistics

Boyd Orr Building

University of Glasgow

Glasgow G12 8QQ

Tel:      +44(0)141 330 4744

Fax:     +44(0)141 357 5588

Web:   Can be accessed here

Pharmacovigilance Enquiries: pharmacovig@glasgowctu.org

A useful guide to research in a Primary Care setting is available here. 

All researchers are required to adhere to the relevant legislation, frameworks and principles and take responsibility for ensuring any staff and students involved in research are familiar with the appropriate requirements.  To achieve working to this level, the Good Clinical Practice Training for Staff Involved in Clinical Research policy outlines the expectation for staff and students to attend Good Clinical Practice (GCP) training, which is integral to the research experience and culture within NHS GG&C.  Each person involved in a clinical trial must receive training in GCP appropriate to their roles and responsibilities.

The NHS GG&C Good Clinical Practice Training for Staff Involved in Clinical Research policy document is available here.

To book a GCP course (1/2 day or full day) please follow the links below: 

• Full day: https://www.nhsresearchscotland.org.uk/research-in-scotland/facilities/clinical-research-facilities/glasgow-research-facility/training-and-courses/browse/20577
• Half day: https://www.nhsresearchscotland.org.uk/research-in-scotland/facilities/clinical-research-facilities/glasgow-research-facility/training-and-courses/browse/16491

Document is available here

We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).

A National process is currently underway to identify interventional, multi-site clinical research studies that are both urgent and should benefit from the support of NIHR CRN, NHS research Scotland, and R&I to fully recruit and/or close in the next year.  Chief Investigators will be contacted directly if their projects have been selected by the funder for the managed recovery process.  There is no intention that this process will result in any pause or withdrawal of support for studies active within NHS GG&C.

(https://www.nihr.ac.uk/documents/guidance-on-the-managed-recovery-of-the-uk-clinical-research-portfolio/27749 _

Since July 2020, NHS GG&C have initiated a local process for restarting all studies paused due to COVID-19. Locally, work continues to ensure that all studies are able to return to normal recruitment activities.  In addition to local efforts and participating in the UK Managed Recovery Process we will continue to prioritise (please note the order does not indicate priority levels):

• NHS GGC locally sponsored/co-sponsored studies and in particular those involving early career researchers who have limited time to complete their funded clinical research.
• Studies that include routine standard of care as an option
• On going “urgent public health COVID-19” studies (e.g., Oxford-Astra/Zeneca, Novavax, Valneva and COV-BOOST vaccine trials; OCTAVE and SIREN etc)