Bringing Quality to Life - QMS in an NHS Investigator Site
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This is a brief description of work done with the Guys and St Thomas' Oncology and Haematology Clinical Trials team in developing a Quality Management System for clinical trials. Included is a scalable model for an investigator site QMS. This was originally presented at the Arena Conference - Clinical Operations in Oncology in 2015.
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Bringing Quality to Life - QMS in an NHS Investigator Site
- 1. Bringing Quality to Life: Quality Management Systems in an NHS Investigator Site Piran Sucindran Quality Manager Oncology and Haematology Clinical Trials Guy’s and St Thomas’ NHS Foundation Trust London, UK
- 2. Bringing Quality to Life Who is the OHCT? What is the OHCT QMS? What is the impact of a QMS at an investigator site? How can a QMS be implemented? How do you engage the investigator site team? What next?
- 3. Oncology and Haematology Clinical Trials (OHCT) Research support team Safety & Support team Clinical trials infrastructure Patient experience and scientific integrity
- 4. Oncology and Haematology Clinical Trials (OHCT) Early Phase Skin, Gynae, Head & Neck Brain & CNS Radiotherapy Lung Haematology Interventional Non-Interventional Urology Breast Gastrointestinal
- 5. The OHCT Quality Management System
- 6. The OHCT Quality Management System
- 7. The OHCT Quality Management System
- 8. The OHCT Quality Management System Deviation Reporting Standard Operating Procedures Quality Improvement Group Engagement and Shared Vision Training Internal Monitoring Resource Management Knowledge Management
- 9. Evaluation of the OHCT QMS What is the impact of the implementation of a quality management system in frontline NHS research? How can a clinical trials team most effectively implement and maintain a quality management system in an NHS investigator site? How does one engage a clinical trials team in an NHS investigator site in the development of and compliance to a clinical quality management system?
- 10. Impact of an Investigator Site Quality Management System Standard Operating Procedures 80% used SOPs as regular source of reference • Amendments • Patient Expenses Reimbursement • Archiving 60% referenced SOPs to Sponsors • Code of Connection • Equipment Maintenance 100% compliance with SOP sign-off Reassurance for Sponsors Continual improvement
- 11. Impact of an Investigator Site Quality Management System Internal Monitoring Systems 82% felt comfortable reporting deviations • Blame-free culture • Support, Improvement and Safety Reassurance that issues are detected and CAPA in place
- 12. 0 5 10 15 20 25 30 35 40 45 Qtr 4 12-13 Qtr 1 13-14 Qtr 2 13-14 Qtr 3 13-14 Qtr 4 13-14 Qtr 1 14-15 Qtr 2 14-15 Qtr 3 14-15 Qtr 4 14-15 Qtr 1 15-16 Qtr 2 15-16 Numberofreportsperquarter
- 14. Impact of an Investigator Site Quality Management System Internal Monitoring Systems 82% felt comfortable reporting deviations • Blame-free culture • Support, Improvement and Safety Reassurance that issues are detected and CAPA in place Performance metrics
- 15. 50% 55% 60% 65% 70% 75% 80% 85% 90% 95% Qtr 1 13-14 Qtr 2 13-14 Qtr 3 13-14 Qtr 4 13-14 Qtr 1 14-15 Qtr 2 14-15 Qtr 3 14-15 Qtr 4 14-15 Qtr 1 15-16 %ComplianceofSourceDocumentation Visit Date
- 16. Impact of an Investigator Site Quality Management System Internal Monitoring Systems 82% felt comfortable reporting deviations • Blame-free culture • Support, Improvement and Safety Reassurance that issues are detected and CAPA in place Performance metrics Audit/inspection readiness
- 17. Implementation and Maintenance of a QMS Comprehensive QMS Mirroring Sponsor/CRO QMS Sponsor engagement Deviation reporting Identifying issues CAPA management Clinical limitations Protocol requirements Continual improvement Limited by ‘over-processing’
- 18. Implementation and Maintenance of a QMS Key aspects Standards External engagement Monitoring Support Training NHS Resources Continuity Risk
- 19. Engagement of SiteTeam 94% team engaged Regular quality input in meetings Senior management Clinical team Non-clinical team Quality Improvement Group External engagement Conferences Protocol consultation Sponsor collaboration
- 21. What next?
- 23. Thank you Piran Sucindran Quality Manager Oncology and Haematology Clinical Trials Guy’s and St Thomas’ NHS Foundation Trust London, UK
Editor's Notes
- The OHCT is a research support team embedded within cancer services at Guys and St Thomas hospitals We consist of research nurses, trial co-ordinators and trial practitioners, with clinical oversight from the clinical research matron, as well as a safety and support team which includes myself, a set-up specialist, an imaging and pathology co-ordinator with oversight from the clinical trials administrator The team provides an infrastructure to support investigators in running cancer clinical trials within the Trust, improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical research
- We maintain a balanced portfolio of around 150 studies at any one time, both commercial and non-commercial, with dedicated teams in a number of therapy areas
- So why did we need a quality system in an investigator site team? Research is an essential part of the NHS, improving healthcare options for the population of the UK, as well as impacting on global healthcare research. However, even though it is considered a priority, clinical research in the NHS can often lack expertise, resources and appropriate structure, becoming overly reliant on the enthusiasm of individuals instead.
- Monitoring at these investigator site therefore takes a more directive role; with the majority of time being spent source data verification and CRF analysis, with little focus on systems being set up at the investigator site to detect and prevent further issues arising. Not only does this require an enormous amount of resource from the Sponsor organisation…
- But an also affect the relationship between Sponsors and investigator sites. The relationship between pharmaceutical companies and investigator sites has sometimes been perceived to be a difficult one; often due to interpretation of regulatory requirements and variability in resources available.
- Core SOPs We initially created a list of core SOPs to reflect key regulatory requirements in research, including pharmacovigilance, informed consent, trial set-up and CRF completion. Alongside these, it was decided that processes needed to be put in place to outline tasks that were not directly associated with regulatory compliance but would assist the team in performing those functions, which may have further regulatory impact. These were called Work Directives (WDs). What initially started as a list of 8 work directives on the way management wanted things done, has now evolved into a set of 26 processes, all of which have been developed by the team themselves. Deviation Reporting Reporting of clinical incidents has been an established part of the NHS for some time. To build on this, we developed of a culture of reporting within our team where both clinical and non-clinical deviations were reported within the team. Each report would then generate a CAPA which would be closed out with oversight from senior management. Feedback would be given to the team member reporting and preventative actions would then feed into the ongoing improvement of the processes. Quality Improvement Group The CTM was engaged in the development of the QMS from the start, and this was key to expediting the initial implementation. However, to get a more rounded perspective in the development of the QMS, a group was created comprising of different members of the team; RNs, CTPs, CTCs and management. Initially this group was focussed on review of SOPs and was called the SOP Committee. However, the focus was broadened to include not just aspects of maintaining quality but also continual improvement, and therefore was renamed the Quality Improvement Group (QIG). This is a monthly group that has been essential in the development, maintenance and evolution of the QMS in the OHCT. In 2014, the group expanded to involve patients in quality improvement and this continues on a quarterly basis. Staff Engagement and Shared Vision As well as the development of the QIG, engagement was an essential component of the QMS. The team was moving from a perceived lack of systems to a portfolio of in-house SOPs and more robust internal monitoring. This fairly extensive change would need to be driven by the team itself for it to be accepted and integrated into regular practice. In order to achieve this, the team was originally given training on what SOPs were and how they could be used. This was followed by developing a Shared Vision within the team, to focus the team on what they wanted to achieve in their work and how a QMS could support them in achieving this. This helped centre the team’s focus and this was reflected in the team’s level of compliance with the new systems in place. Internal Monitoring and Auditing The SpotCheck system, a peer-to-peer monitoring system was developed with a detailed method of providing feedback to the teams and a master database of all findings from SpotChecks, to allow for trend analysis and comparison. Alongside this, the QM instigated an audit timetable, focussing on assessing the team’s compliance with OHCT SOPs and WDs. The SpotChecks themselves were redesigned to focus on compliance with OHCT SOPs and WDs. Training and Competencies Frameworks for training already existed within the OHCT. Each new member of the team underwent a robust local induction with members of the team training new recruits on various aspects of the role. Additionally, clinical competencies were in place, not just for the RNs, but also for CTPs and CTCs new to the clinical environment. Much of this training was not affected by the QMS and oversight has remained with the CRM. However, it became clear that induction training was not uniform and to assist with this induction sessions were reviewed and tailored around the relevant OHCT SOPs, as were competencies. In addition to this, monthly educational meetings were made more robust, introducing external interest subjects about clinical trials (eg results from previous studies) and peer-to-peer training on OHCT SOPs and WDs. The QM would also perform specific training as required (eg a pharmacovigilance refresher course), all of which has been appropriately documented. Resource Management NHS research is driven by the resources available in the NHS hospitals acting as investigator sites. However, it was identified that calibration certificates and maintenance of equipment as per NHS hospital requirements was different to standards required by GCP monitors. This meant that systems were needed to have oversight of these resources. Additionally, one of the key resources of the OHCT team that required management through the QMS was the electronic health records (eHR) system in place. This was developed for clinical purposes and was not originally validated for clinical trials use in line with regulatory requirements. To allow monitors independent access to these records, both to comply with regulatory requirements and to make the clinical trial process more efficient within the OHCT, organisational security measures were put in place utilising SOPs and WDs with internal monitoring and deviation reporting. Knowledge Management A KnowledgeBase was developed by the team as a repository of information which may not necessarily be found in the portfolio of SOPs and WDs. The OHCT QMS continues to be developed by the team and in implementing such a robust system in the way it has been, a quality culture has been created and maintained.
- So to evaluate the system that we set up, we looked at three aspects: What was the impact of implementing a QMS? How can an investigator site effectively implement and maintain a QMS? How do you engage an investigator site team in the development of and compliance to a clinical QMS?
- To evaluate the impact of the QMS, we initially looked at the use of the SOPs. 80% of the team used SOPs as regular sources of reference. The three most commonly used SOPs were those on amendments, patient expenses reimbursement and archiving. This was an interesting spread as, on one side of the spectrum, amendments processing is a task that’s done on a regular basis whereas archiving is only done once per trial. On further analysis, it was found that the amendments SOP was primarily used for its checklist, whereas the archiving SOP was used as an instruction for a process many people were not familiar with. The patient reimbursement SOP is one of note as this was actually developed with the patients as part of our Collaborative Quality Improvement Groups and has now become a regular part of the OHCT workflow. 60% of the team referenced SOPs in discussions with Sponsors. This was mainly regarding the SOP on the code of connection. This SOP was developed as part of organisational security measures that allow us to provide monitors with direct access to our electronic health records; without printing out and without members of the team having to supervise access. These organisational security measures have been put in place to protect the confidentiality of patient notes and maintain compliance with regulatory requirements. Although a software-based alternative is still sought, the ability of the QMS to develop new ideas and implement them as part of our processes meant that the team was able to continue with a systematic approach which has been audited a number of times by Sponsor organisations. As part of every SOP, we have a read and aware sign-off; to demonstrate that not only has each member of the team read every version of the SOPs but also that they’re aware that these SOPs are there as a frame of reference if required. For the last few months this compliance has been 100%. Admittedly, this hasn’t always been the case but by demonstrating to the team how important the processes were and how they reflect not only current regulation but also updated Trust policies and locally improved methods. Sponsors commented that when they are presented with a team that works with SOPs is such an established manner, they feel reassured that they are working with a team dedicated to quality. This reassurance is also picked up by external Sponsor audits, of which we have about 8 a year. It also allows the Sponsors an insight into our processes and the ability to comment on how they may be adapted to fit Sponsor processes, and sometimes even vice versa. The SOPs have also provided a framework for continual improvement. Having formalised processes in place allows you to systematically review these processes, by using process mapping for example, and analyse how the process could be made more efficient or how the process can be adapted to fit in with changes in the regulatory or local environments.
- Another key element in analysing the impact of the QMS was looking at the internal monitoring systems. Deviation reporting has become an important part of monitoring our performance in the OHCT. 82% of the team felt comfortable reporting deviations, with most citing that they felt there was a blame-free culture. Unfortunately, this is not always the case in healthcare incident reporting and in fact the majority who didn’t feel comfortable reporting were mainly nurses who had had bad previous experiences in other organisations. Those that were comfortable felt that they were support in handling the deviation, with focus not so much on what the individual had done wrong but more on where the process had failed and how that process could be improved to avoid further deviations. All agreed that reporting did have a positive impact on the safety of patients and we now use a system within our team which is directly linked to the Trust’s safety reporting as well. One aspect that was surprising was that a few people in the team did not believe that reporting applied to them. These were more senior management staff and it’s been discussed in meetings since that actually everyone has a duty and a right to report deviations. Sponsors commented that the level of vigilance in issue reporting was reassuring for them in the knowledge that issues detected were escalated to the Sponsor organisation immediately and the corrective and preventative action plans developed and executed by the research team meant that these issues were dealt with in a comprehensive manner.
- In fact, the CAPA process for dealing with deviations has had some noticeably positive impact. This is a graph of all deviation reports since January 2013. Due to encouragement of the team and development of internal reporting tools, reporting rose in the first few months of 2013. Then, towards the end of 2013, with more processes being developed as part of the QMS, deviations started to decline. However, deviations then rose again. This is something that we’ve found with all deviations relating to specific processes and on further analysis we found that although putting new processes in place of revising existing ones did have a positive impact on the number of deviations, it also raised awareness of what the right process was and subsequently led to an increase in reporting as people were reporting deviations from the processes themselves. However, with further improvement of the process, this then led to a decrease in reporting again, indicating that this was in fact reflective of a reduction in deviations.
- For example, with amendments, we had an increase in deviations at the start of 2014. We found that this was due to changes in the processes within Trust R&D and the communication with our team. After revising the amendment checklist and clarifying responsibilities with R&D, this then decreased. However, now that people were more aware of the requirements of the SOP, more deviations were reported leading to another increase in reporting. This resulted in further training for the team and a subsequent decrease in incidents.
- The regular peer-to-peer monitoring also allows for real time collection of performance metrics. This allows us to evaluate the current performance of the team but to also compare it to previous results and analyse trends.
- An example of this is the tracking of source documentation. In 2013 many of the teams in the OHCT started using electronic health records. This meant an abrupt end to paper worksheets and prompts which had a noticeable impact on the quality of source documentation. However, with new processes in place and training for research staff the quality of this improved and we’re now looking at almost 90% compliance with our source documentation standards.
- I also carry out a series of internal audits according to a timetable focussed on team compliance to our internal SOPs. With these factors, as well as specific processes for accommodating audits and inspections, we remain at a state of audit and inspection readiness, something that has been picked up by our Sponsors, some of whom have fed back very positively about being confident in the team’s abilities during Sponsor audits. All audit findings are also fed back into the development of the QMS, including process changes and documented training or refresher courses delivered by myself.
- Due to the comprehensive nature of the QMS, the implementation was fairly complex. However, Sponsors recognise that our systems do indeed mirror ones used by Sponsors or CROs. This allows for greater engagement with the Sponsor’s systems and changes in one can be used to adapt the other. Developing a culture of reporting has also benefitted sponsors who feel reassured by the ability of the team to identify issues and develop and implement CAPAs However, it has also been noted that there are clinical limitations to the QMS, making the interaction between the QM and the CRM crucial to ensure that patient safety and experience remains at the core of the team’s practice. One of the other issues we faced was a concern that although the processes in place were fairly comprehensive, they were there to support the research team in conducting studies according to Sponsor protocol, not to be used as a substitute. One key area that highlighted this was the under-reporting of important medical events. This was discovered in a couple of our trials. We decided it needed to be reiterated to the team that the protocol was our primary reference. In fact, we used the phrase “when in doubt, get the protocol out”. Finally, although the SOPs played an important part in structured continual improvement, it was felt that the process for developing these (ie the infamous SOP on SOPs) might actually be a limiting factor in the efficiency of improvement and change.
- The three key aspects of the QMS were identified as a method of ensuring that regulatory standards were met, a tool for engagement with external sponsors and a monitoring tool for ensuring we were compliant with our own processes. These were supported by training, management of NHS resources, establishing continuity of care for patients and integrity of trials in an environment where staff turnover can often be an issue, and finally risk management involving identifying and mitigating risks.
- The development and implementation of such a comprehensive system would not be possible without the engagement of the staff. 94% of the team felt that they were given enough engagement opportunities. The primary source of this was regular discussion of quality issues in group meetings; a senior management meeting where each deviation was discussed along with CAPAs and then escalated to a Trust level, a clinical meeting which involved nurses working with the QM to streamline patient pathways on trials using process mapping, and non-clinical meetings where improvement opportunities are identified and staff members volunteer to be part of quality improvement projects. The primary source of this engagement, however, was the Quality Improvement Group. Key to the successful development and maintenance of the QMS in the OHCT, many people felt that either being a part of the QIG or taking part in specific QIG activities (for example our patient experience event last year) made them feel like they were making a difference to the way we worked and also to the patients we saw. The quarterly patient meetings have added another element to this and our patients now feel engaged with the systems that they experience, which in terms empowers them. We’ve also been looking at further external engagement, with many of our team presenting at conferences and sharing ideas with peers in the research arena and we have also started offering protocol consultation as a service to Sponsors who would like to have a clinical team input on the protocols, possibly even limiting the number of amendments required for trial protocols. Based on feedback from Sponsors we are now looking to further our collaboration with Sponsors in the ongoing development of our systems. Recently Transcelerate have released a concept paper on clinical quality management systems, with a view to developing a framework for Sponsor organisations. We are meeting with representatives later this week to discuss how this could map to our investigator site framework, with a view to bridging the gap between Sponsor and investigator site. We want to know your thoughts on this and welcome your feedback.
- The NHS strives to provide good quality care for our patients and one of the key ways of doing this is through good quality research on a national scale. A framework for managing quality in clinical trials throughout the UK brings this standard one step closer. The establishment of a dedicated team of all levels of staff, including senior management, was key to the development of the QMS. This helped put together a backbone formed of the processes in place and the internal monitoring systems to evaluate the team’s compliance to these, feeding back into each other to keep the processes current and relevant and driving continual improvement. The next level was the further development of resource management and knowledge management tools to ensure continuity within the team. Training and competencies based on the established processes ensured that the team were appropriately trained to conduct site activity and risk management provided a method of monitoring risk factors but also of prioritising mitigation of these risks, feeding back directly into the Trust and NHS requirements for safety reporting. Finally, none of this could be developed to the comprehensive level it needs to be without the engagement of all relevant stakeholders; from ensuring staff at the investigator site understand the need for the systems and embrace them, Sponsor input is readily received and actioned and that patients have an input into the service they receive.
- So now we have to decide where to go next. Our system is a dynamic one, feedback from risk management and internal monitoring shape our continual improvement and process development allows us to adapt to local and international changes in regulations. However, we want further input from Sponsor organisations and really engage with the pharmaceutical industry in how we take this forward, creating a true collaboration between Sponsors and investigator sites.
- I’d like to thank Kings Health Partners and Guys and St Thomas’ as well as the Research Quality Association and Cranfield University However, most of all, I’d like to thank the OHCT team, whose enthusiasm for being a part of scientific progress and compassion for the patients in their care has made the development of this system a possibility.