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Good clinical practice (GCP) for research procedure

Contents

1 Aim

The aim of this procedure is to set out the minimum training requirements for staff involved in research in Rotherham Doncaster and South Humber (RDaSH) NHS Foundation Trust. It will set out requirements for clinical trials of investigational medicinal products (CTIMP) trials and non-CTIMP research at a training level appropriate for individuals’ level of involvement and in compliance with International Conference on Harmonisation (ICH) good clinical practice (GCP) guidelines and legal requirements for CTIMP trials. This document will clarify requirements for staff involved in research activities at different levels of responsibility.

2 Background

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.

The “Joint statement from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) on the application of good clinical practice to training for researchers” advocates a proportionate approach to the application of good clinical practice training.

Different types of research may require different training, and some researchers are already well trained and competent in their area of expertise. Whilst it is important for researchers to be appropriately trained, researchers can sometimes be required, inappropriately and often disproportionately, to undertake good clinical practice training when they do not conduct research in the field of CTIMPs and devices or where their involvement in the trial is minimal and entirely within their professional expertise. In some cases, good clinical practice fundamentals or good clinical practice awareness is sufficient as per the National Institute for Health and Care Research algorithm (see appendix B).

3 Scope

This procedure applies to all staff undertaking research at the trust, including clinical and non-clinical staff.

This procedure describes the process and expectations for researchers and staff involved in delivering different types of research. It is applicable to trust staff, and staff working under an honorary contract or letter of access (see research passport, honorary collaboration contract, honorary research contract, letter of access procedure) involved in research studies sponsored and hosted by the trust where those studies are covered by the UK Policy Framework for Health and Social Care Research and require Health Research Authority, Research Ethics Committee and, or Medicines and Healthcare products Regulatory Agency approvals.

To ensure all trust staff participating in clinical research are appropriately qualified and trained to meet research governance, regulatory and trust requirements and can produce evidence of such training.

To outline the responsibilities of all research staff in the maintenance of their own individual training files.

To outline the requirements for all research staff to attend good clinical practice training.

4 Responsibilities

4.1 All researchers and research staff (site, co-ordination and central facility staff)

4.1.1 Tasks (good clinical practice training)

  • All studies conducted by the trust (sponsored and hosted).
  • All staff who work directly on any research project, should complete good clinical practice training prior to commencing work on any project at any trust location.
  • The trust recommends the National Institute of Health and Social Care (NIHR) good clinical practice introduction and refresher courses, if other training has been completed the research governance manager will assess whether it is at an appropriate level for the intended study.
  • Training should be agreed with an understanding of the research protocol and the individual’s role on the trial. The researcher’s level of knowledge should enable them to accurately perform their allocated role.
  • Training should be proportionate to the researcher’s role within the Study team.
  • Where involvement in the trial is minimal and entirely within an individual’s professional expertise, in some cases, good clinical practice fundamentals or good clinical practice awareness is sufficient as per the National Institute for Health and Care Research
    algorithm (see appendix B).
  • Where there is any doubt regarding good clinical practice training requirements the advice of the research governance manager should be sought.
  • Researchers should ensure that they are appropriately trained prior to commencing work on any research project, trial or study.
  • Where the sponsor requested training is lower than the NIHR good clinical practice introduction or refresher training, they will be required to complete the National Institute for Health and Care Research training in addition to the sponsor training.
  • Study specific training may be required in addition to good clinical practice training. This should include review of the protocol, study specific procedures and manuals and any training allocated to the individual’s role (for example, randomisation, unblinding or case report form (CRF) completion).
  • Training can be delivered as part of a site initiation visit (SIV) but should also be carried out for all new staff.
  • Researchers should work in compliance with trust polices, standard operating procedures, and the trial protocol.

4.2 Chief investigator

4.2.1 Tasks (studies sponsored by the trust)

  • The chief investigator and study team should attend a good clinical practice training course prior to being delegated responsibilities on any clinical research project.
  • The chief investigator of trust sponsored trials have overall responsible for coordinating and ensuring site personnel are appropriately trained prior to working on a study. The chief investigator is responsible for ensuring that all co-ordination personnel have had appropriate training.
  • The chief investigator should also ensure that at site initiation all site personnel have had appropriate training prior to activating the site.

4.3 Sponsor

4.3.1 Tasks (studies sponsored by the trust)

  • Where a trial is multi-centre trust as sponsor can provide participating sites advice on minimum good clinical practice training requirements for the intended study.
  • Where the trust as sponsor require training that is lower than that required by the site’s policies, researchers will be required to complete training as required by their employing organisation.

4.4 Principal investigator

4.4.1 Tasks (externally sponsored studies hosted by the trust)

  • The principal investigator of trust hosted studies have overall responsibility to ensure that all site personnel have had appropriate training prior to commencing work on the project. Evidence needs to be filed in the investigator site file.
  • The principal investigator and study team should attend a good clinical practice training course prior to being delegated responsibilities on any clinical research project.

4.4.2 Tasks (clinical trials of investigational medicinal products trials hosted at the trust)

  • For clinical trials of investigational medicinal products (CTIMP) studies good clinical practice is a legally mandated requirement and must be completed at the level required by the sponsor by all research staff on the delegation log.
  • It is the responsibility of the principal investigator and research governance manager to establish with the external sponsor what training is required.

4.4.3 Tasks (non-clinical trials of investigational medicinal products trials hosted at the trust)

  • For non-clinical trials of investigational medicinal products (CTIMP) hosted studies all staff directly involved in the research should have a current good clinical practice certificate, at the level required by the sponsor prior to commencing work on any project at any trust location.
  • It is the responsibility of the principal investigator and research governance manager to establish with the external sponsor what training is required.

Researchers should work in compliance with trust polices, standard operating procedures, and the trial protocol.

4.5 All researchers and research staff (site, co-ordination and central facility staff)

4.5.1 Tasks (research curriculum vitae)

  • Under International Conference on Harmonisation good clinical practice all researchers on a study delegation log should have a current research curriculum vitae (CV).
  • Individual researchers working on a research project should ensure an up-to-date CV is present in the trial master file or investigator site file as applicable.
  • CVs should be updated at least on a 2 yearly basis or when a new role or training is undertaken. Often commercially sponsored clinical trials of investigational medicinal products trials require an updated CV with wet ink signature every 12 months.
  • It is advised that researchers use the research and development (research and development) CV template to ensure relevant information is captured (see appendix D).

5 Link to overarching policy

6 Procedure

6.1 Trust requirements

All principal investigators, co-investigators and research staff, and clinical staff working on clinical research studies, within the trust are expected to undergo good clinical practice training at an appropriate level for their role on the study.

The National Institute for Health and Care Research (NIHR) delegation and training decision aid (see appendix B) provides guidance, and the research governance manager will advise on the appropriate level of training for specific studies and study roles.

Principal investigators are responsible for ensuring that staff in their research teams receive good clinical practice training appropriate to the study they are undertaking, before they are signed off on the study delegation log and prior to their involvement in a research study.

The trust requires research active staff to have undertaken a nationally recognised course. To this end, courses such as NIHR good clinical practice training, introduction, consolidation or refresher courses or equivalent are accepted as an appropriate level of training.

Good clinical practice training must be renewed every two years throughout the individual’s involvement in research.

Some commercial sponsors require principal investigators to undertake their own in-house training, this would also be accepted. If the training is at a lower level to the NIHR good clinical practice training both will be required.

Staff who are supporting research but not in the direct research team and who are undertaking activities that follow the normal care pathway, or the activity is deemed as without freedom to act, may complete a fundamentals good clinical practice training session run by the trust Research Governance team or they can complete on-line good clinical practical training if they prefer (see appendix B).

Curriculum vitae’s (CVs) should be updated at least on a 2 yearly basis or when a new role or training is undertaken. Often commercially sponsored clinical trials of investigational medicinal products (CTIMP) trials require an updated CV with wet ink signature every 12 months, therefore all Grounded Research delivery staff will be sent an automatic reminder via the Edge database every 12 months This process is managed by the Research Governance team (see good clinical practice and CV Edge LWI)

6.2 Training courses

National Institute for Health and Care Research good clinical practice Introduction, Consolidation and Refresher Training (opens in new window).

Trust fundamentals training can be arranged by contracting the Research Governance team at: rdash.research-gov@nhs.net.

6.3 Evidence of training

A copy of the certificate should be forwarded to the Research Governance team either by e-mail to rdash.research-gov@nhs.net or through the internal post addressed to:

Grounded Research
2 St. Catherine’s Close
Tickhill Road Hospital Site
Doncaster
DN4 8QN

A copy of the certificate should be retained in the individual’s personal training file.

Copies of the certificate should be included in the investigator site files of the research studies that the staff member is involved in, or a file note should be present in the site file to explain where the certificate is held.

The Research Governance team will maintain a record of good clinical practice training and for research active staff a reminder will be sent after 2 years. However, it remains the responsibility of individual to ensure that they update their training in a timely manner.

7 Policy

This procedure is mandatory and non-compliance with it may result in suspension of research activity.

8 Appendices

8.1 Appendix A Definitions of acronyms used

Definitions
Term Definition
CI Chief investigator
CTIMP Clinical trial of an investigated medicinal product
Device Any device that is used medically
DHSC Department of Health and Social Care
GCP Good clinical practice
HRA Health Research Authority
ISF Investigator site file
MHRA Medicines and Healthcare products Regulatory Agency
NIHR National Institute for Health Research
NMC Nursing and Midwifery Council
Non-CTIMP Non-clinical trial of investigational medicinal products (non-drug and device trials)
NRES National Research Ethics service
PI Principal investigator
R&D Research and development, often refers to the research governance function
RGM Research governance manager
REC Research Ethics Committee
TMF Trial master file

8.2 Delegation and training decision aid

8.3 Appendix C Joint policy on the application of good clinical practice to training of researchers

The Health Research Authority, Medicines and Healthcare products Regulatory Agency, Devolved Administrations for Northern Ireland, Scotland and Wales).

8.3.1 Annex A

The Medicines for Human Use (Clinical Trials) Regulations (2004) (as amended)

Amended by S.I. 2006 No 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations (2006).

Conditions and principles which apply to all clinical trials.

8.3.1.1 Principles based on articles 2 to 5 of the good clinical practice directive (commission directive 2005/28/EC)
  1. The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society.
  2. Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.
  3. Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.
  4. The necessary procedures to secure the quality of every aspect of the trial shall be complied with.
  5. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
  6. Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki.
  7. The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.
  8. The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.
  9. All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.
8.3.1.2 Conditions based on article 3 of the directive
  1. Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  2. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist.
  3. A trial shall be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.
  4. The rights of each subject to physical and mental integrity, to privacy and to the protection of data concerning him in accordance with the Data Protection Act (1998) are safeguarded.
  5. Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.

8.4 Appendix D Submission of curriculum vitae, to research ethics committees and NHS research and development officers

8.4.1 Guidance for applicants

Your curriculum vitae (CV) needs to demonstrate that you are qualified by education, training and experience to conduct the research.

A standard template for an investigator CV is set out below. This template would be suitable for submission of CVs by:

  • chief investigators (for submission with main Research Ethics Committee application)
  • local principal investigators (for submission with the site-specific information form to Research Ethics Committees and NHS research and development offices)
  • academic supervisors (for submission with student applications).

The template is issued as guidance and is not intended to be prescriptive. Use of the template is not a requirement for a valid application.

The National Research Ethics service standard operating procedures state that CVs should be a maximum of 2 pages. This is also guidance and is not an absolute requirement.

It is important that experience relevant to the specific research project is fully summarised, but the overall document should be kept concise. It is not necessary to provide a complete record of the applicant’s professional and academic background. In particular, CVs should not include lengthy lists of publications.

This template is recommended by the National Research Ethics service and the NHS research and development forum for applications both for ethical review and research and development approval.

9 References


Document control

  • Version: 1.
  • Unique reference number: 1099.
  • Date approved: 14 January 2025.
  • Ratified by: Research and innovation clinical leadership executive group.
  • Name of originator: Research governance manager.
  • Name of responsible individual: Medical director.
  • Date issued: 22 January 2025.
  • Review date: 31 January 2027.
  • Target audience: Trust wide.
  • Description of change: New procedure.

Page last reviewed: January 22, 2025
Next review due: January 22, 2026

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