Appendix A: Summary of RD&I risk profile

Risk Score

Escalation group

15 or above

Executive Management Board (EMB) and RD&I Sub‑Committee. These risks are the responsibility of the EMB and RD&I Sub‑Committee to ensure effective management and resolution. Risks are further escalated to Trust Board, if the RD&I Sub‑Committee determines the risk to require Trust Board involvement or is a Trust‑wide issue and so out of scope of the Research & Development Service.

8 to 14

Review action at Research, Development, and Innovation Operational Management Group and close within 6 months.

4 to 7

Review action at Research, Development, and Innovation Operational Management Group and close within 12 months.

1 to 3

If agreed no further action, risk can be closed and re‑assessed if there is a recurrence of the risk.

1.

2200

The RADIOTHERAPY SERVICE risk (Risk ID 2200) was made visible in Datix to the Research Service in March 2024. The risk has been assessed for impact on the Research Service’s ability to continue service delivery:

1. Capacity to meet the Trust’s existing contractual requirements to deliver clinical trials requiring patients to receive radiotherapy treatment.
2. Capacity to offer patients opportunity to take part new clinical trials where they would receive radiotherapy treatment.

The controls / action plans put in place to address the Research Service’s aspects of this risk, and their progress are described in the “Controls / Action Plan & Progress” column.

The RADIOTHERAPY SERVICE risk has an inherent risk score of 20 and has previously been escalated to the Trust Executive Management Board. The RADIOTHERAPY risk is owned by that service and is described below for reference:

RADIOTHERAPY CAPACITY

There is a risk to whole of Radiotherapy Performance and Service as a result of insufficient capacity within the current linear accelerator fleet, leading to the radiotherapy service being unable to meet the current and anticipated demand.

The lack of sufficient capacity within the Radiotherapy service has had the following consequences:-

Compliance risk

• An inability to maintain waiting times compliance.
• Creation of waiting lists.
• Inability to meet RCR clinical guidelines.

Patient safety risk

• Patients will wait longer to start treatments resulting in possible poorer clinical outcomes, lack of symptom control and poor patient experience.

Reputational risk

• Limited service developments with a corresponding delay or inability to meet IMTP objectives.
• Restricted ability to participate in clinical trials or research projects.
• Issues with recruitment and retention of staff.

01 May 2011

12

06 Aug 2024.

1. The Research Service is in regular communication with the Radiotherapy Service to discuss their capacity in managing existing clinical trials with radiotherapy treatment and meet Trust contractual requirements. This is achieved through a number of mechanisms:
   1. Trust R&D Office representation on the Radiotherapy Trials Portfolio Group, which assess and discuss the impact of Radiotherapy Service changes on the delivery of existing clinical trials, allowing prioritisation discussions to take place.
   2. Regular meetings between the Head of R&D, Research Delivery Manager, and Superintendent Radiographer – R&D.

Through these mechanisms, the existing clinical trials with radiotherapy have been assessed and the Trust is able to meet its contractual requirements.

2. The Research Service’s Head of R&D and Research Delivery Manager are part of the established Radiotherapy Trials Solutions Group chaired by Dr Paul Shaw (Consultant Clinical Oncologist) that has made recommendations to improve the situation. Work is underway to implement and monitor these recommendations made by the group, to ensure that the Trust is able to set-up and deliver new clinical trials with radiotherapy treatment within the capacity constraints alongside the existing portfolio of trials; and aligned with the Radiotherapy’s service re-design as part of the Integrated Radiotherapy Solutions (IRS).

The above actions will allow the Trust to continue to deliver its current contracted portfolio of trials with radiotherapy treatment and offer patients opportunities to take part new trials aligned with the IRS development.

The Radiotherapy Service’s IRS programme of work will see the implementation of a treatment and planning system supplied from a single vendor. Any changes resulting from the work that could affect the Trust’s ability to deliver trials with radiotherapy treatment is considered through ongoing discussions with the Research Service and Clinical Teams.

8

Open

Research / Trials = Adequate

Radiotherapy Services Manager

2.

3252

Cardiff & Vale University Health Board (CVUHB) unable to keep up with Velindre University NHS Trust’s (VUNHST) support requests for research study radiological biopsies.

09 Nov 2023

20

1. Continuing to set‑up research studies where biopsies are optional or can be undertaken at Velindre Cancer Centre (VCC)
2. Continuing to set‑up research studies with mandatory biopsies using support requests to CVUHB on a case‑by‑case basis.
3. Work ongoing with CVUHB Joint Research Office & CVUHB Radiology to resolve issue.
4. VUNHST R&D commercial radiology sessions supporting the identification of radiological biopsy requirements as part of study set‑up.
5. VUNHST exploring support service agreements with other organisations.

8

Open

Adequate

Head of R&D

1.

3186

Recent vacancies in Velindre Cancer Centre’s (VCC) means a possible slowing of research study set‑up and patient recruitment is required, meaning a reduction in new studies opened and recruitment numbers. May also delay VCC Pharmacy’s ability to support studies/service at Cardiff Cancer Research Hub (CCRH).

22 Aug 2023

15

15 Oct 2024

1. All vacancies have been recruited into. Progress to be reviewed in December 2024 following all staff being onboarded and training completed.
2. VCC Pharmacy and Trust R&D Office are collaborating on the prioritisation of research studies for set up and recruitment.

21 Aug 2024

1. Additional Pharmacist resource in place (0.4WTE Band 7 from general Pharmacy budget); individual is new to trials and will take time to upskill.
2. Principal Pharmacist for Clinical Trials recruited with a start date 4th November 2024.
3. BioNTech funded posts in final stages of recruitment.
4. No material reduction in risk as throughput of new trials remains restricted and a backlog has developed.

23 Apr 2024

1. VCC Pharmacy have made appointments to vacant posts, and staff have begun with the organisation during March/April 2024.
2. VCC Pharmacy are in the process of training new appointments to support trial setup and delivery.
3. VCC Pharmacy and Trust R&D Office meet weekly to discuss the priority trials and the progress in returning the pharmacy service to full capacity.
4. Trust R&D Office continue to work with the site-specific teams to compile trial prioritisation list to aid prioritise the work for VCC Pharmacy.
5. VCC Pharmacy and Trust R&D Office to review the core pharmacy team staffing to support study set up and recruitment at a future time point.

8

Closed

Adequate

Chief Pharmacist

2.

3251

Breach of confidential data when study participant data sent to Sponsor organisation via an unsecured electronic method.

18 Sep 2023

12

1. Staff ceased transmission of data until secure electronic portal in place and working.
2. Staff re‑trained on Information Governance.
3. Staff training on use of secure electronic portal and importance of use.
4. Secure electronic transmission pathways to be set‑up prior to recruitment of first participant for all future studies.
5. Sponsor organisation informed, corrective and preventive action (CAPA) log completed with study file note shared with Sponsor and entered into Investigator Site File.

3

Closed

Adequate

Senior Research Nurse Manager

3.

3250

Loss of minus‑80 Celsius freezer integrity in Clinical Research Treatment Unit (CRTU).

28 Jun 2023

12

1. Immediate action to re-locate frozen samples to Welsh Blood Service (WBS) facilities.
2. Informed all sponsor organisations of freezer integrity loss and to arrange sample shipment.
3. Worked with freezer maintenance company on identifying fault and restarting freezer.
4. Updating sample management procedures, re‑trained staff on processes, and ensuring timely shipment of samples to Sponsors, limiting numbers of samples on site.
5. Sponsor organisations informed, corrective and preventive action (CAPA) log completed with study file notes shared with Sponsors and entered into Investigator Site Files.
6. To collaborate with Welsh Blood Service (WBS) to implement a business continuity plan.

4

Closed

Adequate

Research Delivery Manager

4.

3249

Trial sub‑investigator consented study participant without being signed off on delegation list or study training log.

11 Jul 2023

9

1. Having returned from maternity leave, Sub‑Investigator re‑instated on delegation logs and completing required training logs.
2. Principal Investigator(s) countersigning relevant delegation logs and training logs.
3. Sponsor organisation informed, corrective and preventive action (CAPA) log completed with study file note shared with Sponsor and entered into Investigator Site File.
4. Trust R&D Office regularly reminds all Principal Investigators of importance for all delegated staff to complete delegation logs and training logs.
5. Standard Operating Procedure to be updated to address re-instatement of delegation and study training on returning from extended leave.

3

Closed

Adequate

Research Delivery Manager