Sponsoring a clinical trial
When a non-commercial organisation (such as a hospital or academic institution) takes on sponsor responsibilities for a clinical trial, there are a number of regulatory and legislative responsibilities they must comply with. Some organisations will have dedicated Sponsor pharmacy teams that are integrated into the Research and Innovation Departments. Others will seek Pharmacy support from their local site Pharmacy team.
This series of articles provides guidance to aid clinical trial sponsors in identification of tasks which require completion when undertaking the role of the sponsor pharmacy.
Defining the sponsor
For the purposes of this document, the term Sponsor includes the non-commercial Sponsors in primarily NHS sites, but may have close university partners that they Co-Sponsor with or charity partners that the NHS team undertake Sponsor work on behalf of.
Regulation of clinical trials
The European Union (EU) Good Clinical Practice (GCP) Directive 2001/20/EC was introduced to establish standardisation of research activity in Clinical Trials throughout the European Union. It was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) which came into force on 1st May 2004. The Medicines for Human Use (Clinical Trials) Regulations together with subsequent amendments will be referred to as the Regulations in the rest of this document.
All clinical trials involving investigational medicinal products (IMPs) must be conducted according to the principles of GCP.
The purpose of this resource is to:
- Outline the key areas where Sponsor should focus pharmaceutical expertise in the set up and conduct of a CTIMP sponsored by their organisation
- Ensure there is appropriate oversight of the IMP-related aspects of the trial from a Sponsor point of view
- Acknowledge this is different from the day-to-day management of pharmacy related aspects of trials, which is the responsibility of the clinical trials lead pharmacist at each site.
This document should be read in conjunction with the National Pharmacy Clinical Trials Advisory Group – Professional Guidance on Pharmacy Services for Clinical Trials, endorsed by RPS (Royal Pharmaceutical Society) Version 2.1, April 2019 or subsequent amendments. Within this document, the ‘Sponsor Lead Pharmacist’ will be referred to. Where local practices allow this may be a role delegated to another appropriately qualified member of the pharmacy team as appropriate.
Studies with non-CTIMPs
Studies supported by non-commercial Sponsors which involve medicines but are classified as non-CTIMP are outside the scope of this document. It is recommended that consideration be given to the level of risk each of these studies poses and the level of oversight and management the pharmacy department may need to commit to ensure participant safety, on behalf of the Sponsor. Decisions relating to this are advised to be made in conjunction with the Sponsor team.
This series of articles describes a process flow outlining key requirements when sponsoring a clinical trial whilst ensuring appropriate pharmacy oversight for NHS sponsored CTIMPs. There are a series of downloadable appendices to be used as guidance for implementing effective IMP management oversight, which are also linked at the bottom of this page.
Templates have been produced for local use to assist the sponsor in performing specific tasks.
Appendix 1: division of responsibilities
To allocate roles and responsibilities to key stakeholders.
Appendix 2: IMP risk assessment
To complete a risk assessment related to IMP activities. Sponsor pharmacy input is required.
Appendix 3: quality technical agreement
To agree technical and quality parameters when outsourcing any aspect of IMP manufacture or supply.
Appendix 4: pharmacy site feasibility form
Feasibility form to determine if sites can deliver a trial
|Contract Acceptor- Manufacture|
|CoA||Certificate of Analysis|
|COSHH||Control of Substances Hazardous to Health|
|CTA||Clinical Trial Application|
|CTIMPs||Clinical Trials of Investigational Medicinal Product|
|CTU||Clinical Trials Unit|
|DAPs||Drug Analysis Prints|
|ETC||Excess Treatment Cost|
|GCP||Good Clinical Practice|
|GDP||Good Distribution Practice|
|GMP||Good Manufacturing Practice|
|HRA||Health Research Authority|
|ICH||International Conference of Harmonisation|
|IMP||Investigational Medicinal Product|
|IMPD||Investigational Medicinal Product Dossier|
|IRAS||Integrated Research Application System|
|MHRA||Medicines and Healthcare products Regulatory Agency|
|NIMP||Non-Investigational Medicinal Products|
|PSF||Product Specification File|
|QTA||Quality Technical Agreement|
|RAF||Risk Assessment Form|
|REC||Research Ethics Committee|
|RPS||Royal Pharmaceutical Society|
|SAE||Serious Adverse Event|
|SIV||Site Initiation Visit|
|SLA||Service Level Agreement|
|SmPC||Summary of Product Characteristics|
|sIMPD||Simplified Investigational Medicinal Product Dossier|
|SOP||Standard Operational Procedure|
|SUSAR||Suspected Unexpected Serious Adverse Reaction|
Crown Copyright (2012). The Medicines for Healthcare products and Regulatory Agency. Good Clinical Practice Guide. The Stationary Office
DoH Publication: Attributing the cost of health and social care Research & Development (AcORD). Document and Annexes A and B accessible via: Attributing the costs of health and social care research – GOV.UK
The National Pharmacy Clinical Trials Advisory Group would like to thank the following authors of, and contributors to, this guidance:
Beatriz Duran – Consultant Pharmacist – Clinical Trials and ATMPs – Manchester University NHS Foundation Trust
Anne Black – Regional QA Specialist Pharmacist – North East and North Cumbria
Maria Allen – Pharmacy Clinical Trials Operations Manager – The Newcastle upon Tyne Hospitals NHS Foundation Trust
Penny Bradley – Senior Lead Clinical Trials Pharmacist – The Newcastle upon Tyne Hospitals NHS Foundation Trust
Adam Walker – Highly Specialist QA Pharmacist and QP – The Newcastle upon Tyne Hospitals NHS Foundation Trust
Samantha Carmichael – Lead Pharmacist Clinical Trials/Research & Innovation – NHS Greater Glasgow & Clyde
Lynne Whitehead – Head of Pharmacy Clinical Trial Services – Cambridge University Hospitals NHS Foundation Trust
Angela Hallam – QP and Production Manager – Cardiff & Vale University Health Board
Cheryl Lawrence – Sponsor Research Pharmacist – Barts Health NHS Trust
For further information about the NPCTAG
For further information relating to the content of this guidance