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Guide for Chief Investigators

 

Contents

Introduction to the guide

NIHR Portfolio adoption enables access to a research infrastructure provided by the NIHR Clinical Research Network (CRN) which aims to facilitate participation and study recruitment. Efficient study recruitment is the main goal and the CRN measures this in a number of ways, one of the most important of which is to recruit a defined number of participants within a pre-planned period of time. The study sponsor is required to work with CRN delivery teams to facilitate measurement of research activity. Study Chief Investigators (CIs) play an important role in study conduct. A study sponsor or clinical trials unit may set out contractual obligations associated with undertaking the CI role. It is important that CIs also recognise their responsibilities to facilitate delivery of their study.

Please read this guide if you are or expect to be the CI of an NIHR Portfolio study. The purpose of this guide is to highlight key stages where the CRN needs your help to support the delivery of your study. It is not intended as an exhaustive list of the roles and responsibilities of being a CI, but explains the key points at which you will be required to interact with the CRN.

Chief Investigator responsibilities in study delivery

The NIHR CRN supports researchers and the life sciences industry to develop, set-up and deliver high quality research to time and target in both the NHS and in the wider health and social care environment, across England. It is accountable for overall delivery of your study, using the CRN Study Support Service.

The NIHR clinical trials portfolio consists of high-quality clinical research studies that are eligible to access support from the CRN. It is part of the wider UK CRN Portfolio, which includes studies from Northern Ireland, Scotland and Wales as well as England. Recruitment activity is held on a single database called the Central Portfolio Management System (CPMS). CPMS collates site level information to provide study-wide oversight, which enables proactive performance monitoring to ensure your study recruits on time and meets its recruitment target.

So that the CRN can support you and your study effectively, you are required, as CI, to engage with CRN and help ensure the efficient delivery of your study. Your main point of contact will be your lead Local Clinical Research Network, which is determined by your geographical location.

As CI it is your responsibility to maintain oversight of your study. You may have delegated many of the functions described below to a sponsor study team or Clinical Trials Unit, but ultimately you are accountable to ensure these responsibilities are fulfilled. For commercial-sponsored and international (e.g. EORTC) studies, it is important that CIs recognise they are ambassadors for UK clinical research. Clinical study performance is a major influence on sponsor decisions about whether or not to bring new studies to the UK.

Key Chief Investigator responsibilities

  1. Be familiar with how the NIHR Cancer Portfolio is developed and delivered across England and the UK.

  2. Ensure the study sponsor and, where appropriate, clinical research organisation (CRO), or clinical trials unit (CTU), is fully aware of the role and remit of NIHR CRN and its obligations to engage with CRN delivery teams to monitor study activity and upload recruitment activity in a timely manner.

  3. Contact your lead LCRN as early as possible about your study to ensure the relevant expertise, resources and support are in place to set up and deliver your study. Amongst other things your lead LCRN can support you in:
    - Completing the Schedule of Events Cost Attribution tool (SoECAT)
    - Helping to identify potential sites (both at the start of and during your study) and setting appropriate recruitment targets
    - Facilitating NHS Permission processes at sites
    - Initiating and maintaining contact with sites to ensure any issues are dealt with in a timely manner
    - Monitoring individual site and overall study recruitment, as well as providing feedback regarding any barriers to recruitment, if they are identified

  4. Ensure that your CPMS study record is regularly updated, paying particular attention to the:
    - Study contact details
    - Open and closure dates
    - Sample size and changes to the sample size over time
    - Notification of substantial amendments
    - Provision of an adequate research summary
    - Whether the study is open or closed to new sites
    - Accurate recording of recruitment

  5. When a study is included on the NIHR Portfolio it is assigned a managing specialty and if applicable co-supporting specialties based on the speciality area(s) from which participants will be recruited. This is determined from the information provided in the IRAS form. As CI you will be informed which specialty area your study has been allocated to in the email entitled ‘Accessing your study record in the NIHR Central Portfolio Management System (CPMS)’ which confirms the speciality area(s) your study has been allocated to. The email also gives you the opportunity to suggest a change to the specialities allocated as well as suggest any co-supporting specialties.

  6. In addition to the specialty areas assignation, studies are also assigned relevant subspecialty areas. For cancer there are 13 subspecialties. The subspecialties are based on disease sites for the most part, but also include cross cutting areas such as Teenage and Young Adult Cancer. Information on what additional labels including subspecialty areas is attached to your study record.

  7. It is the study sponsor’s responsibility to ensure accurate recording of recruitment. Since April 2019, recruitment is now gathered at a loco-regional level, using a Local Portfolio Management System (LPMS) from where recruitment data is automatically uploaded to CPMS to provide real-time UK-wide recruitment activity information. CIs should know who their recruitment activity co-ordinator is and ensure that there is a process in place to confirm recruitment and resolve any queries on a monthly basis. Delays in confirming recruitment will be escalated to CIs, as this has a direct impact on performance management of your study.

  8. LCRN delivery managers work with the CRN Research Delivery Directorate (RDD) to review the Cancer Portfolio on a quarterly basis and identify studies that may be at risk of not delivering to time and target. The intention is to identify difficulties encountered by sites and help find and implement solutions. If your study is identified as being at risk of not meeting time and targets set, you may be contacted by your lead LCRN, or RDD, to discuss any support you may need to deliver the study. This may include an invitation to join one of the monthly CRN Research Delivery Manager teleconferences to highlight key issues in the delivery of your study and consider potential solutions.

  9. Once the study has closed, CIs will be contacted to provide feedback on positive experiences as well as any difficulties experienced and lessons learned during the conduct of their study. This information will inform future studies and improve the service quality offered by CRN, so enhancing the conduct of current and future research across the UK.

Key Contacts 

If you have any queries about your study record or the delivery of your study please contact the Coordinating Centre using the following emails:

Non-commercial studies – crncc.portfoliob@nihr.ac.uk
Commercial studies - crncc.support@nihr.ac.uk