Pharmacovigilance and Safety Reporting

The MHRA Good Clinical Practice Guide defines pharmacovigilance as ‘the science of collecting, monitoring, researching, assessing and evaluating information on the adverse effects of medicines, with a view to identifying information about potential new hazards and preventing harm to subjects.’  MHRA GCP Guide, 2012.

I’ve had an interest in pharmacovigilance for a number years now, ever since I completed my Masters degree in Clinical Research, where I completed my dissertation on ‘Pharmacovigilance and adverse drug reaction reporting within a central London hospital.’ I later went on to undertake my PhD, investigating the benefit-risk of medicines, and incorporating the patient’s perspective. I submitted my PhD thesis in April 2018 and I still await the viva voce! (Gulp).

During a drug’s lifecycle, evidence must demonstrate that the benefits of the product continue to outweigh the risks. Benefit-risk (B-R) assessment is a vital stage of the drug approval process and is an important task for pharmaceutical companies and regulatory agencies. Medical assessors, pharmaceutical company and regulatory agency personnel, patient advocates and patients are all involved in B-R assessment. My thesis investigated the patient’s perspective and how patients can become involved in the process of B-R assessment, and I found the research incredibly enlightening.

After completing my research, I decided to develop the content into a one day workshop, therefore, Paul Cross Consulting and Siobhan Lim Consulting are pleased to announce the launch, which has now been confirmed for November 2018.

This one-day workshop will cover the principles of pharmacovigilance as well as the reporting requirements for both sponsors and investigator sites. The scientific justification for pharmacovigilance will be described as will the importance of benefit-risk assessment in clinical trials. The workshop is designed for NHS / academic staff whose role involves pharmacovigilance governed by the regulations required for clinical trials of medicinal products. For example, sponsor representatives, investigators, research nurses, trial managers, project managers, QA staff or R&D staff. Management staff who supervise staff responsible for pharmacovigilance reporting, or clinical research staff preparing for GCP audit or GCP inspection, will also find this workshop of interest.

Course objectives

Upon completion of this workshop you will be able to:

  • Define the scientific principles of pharmacovigilance and benefit-risk assessment in clinical trials
  • Describe the requirements of adverse event recording and medical evaluation and assessment
  • Define serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs)
  • State the reporting requirements at the investigator site and sponsor level
  • Develop a development safety update report (DSUR)
  • Understand the requirements of EudraVigilance
  • Be aware of the changes to pharmacovigilance legislation and the impact on clinical research
  • State at least 3 examples of non-compliance around adverse event and serious adverse event reporting.


You can find out further information about the course here.










Computer Systems Validation and Electronic Healthcare Records

The MHRA released a position statement in December 2015 detailing their requirements for Electronic Health Records (EHRs) – reference available here. As NHS Trusts move towards electronic health records and away from paper notes, it is essential that regulatory requirements are considered. EHR systems are now becoming the principal source of data and information for participants in research studies; including those regulated by the MHRA.

Computer Systems Validation is an important process which enables you to demonstrate that any of the computer systems you use within your trials are fit for purpose. Paul Cross Consulting and Siobhan Lim Consulting are pleased to announce that we have developed a workshop around CSV and EHR. This workshop covers everything you need to know about CSV in order to remain compliant with the MHRA’s requirements.

The workshop is designed for NHS and academic staff who are involved in managing quality systems, for example, quality assurance managers, research governance managers, clinical research associates, monitors, trial managers, project managers and R&D staff. Management staff, responsible for supervising quality assurance staff or managing oversight of research activity, will also find this workshop of interest.


Course objectives

Upon completion of this workshop you will be able to:

  • Understand and define the purpose of computer systems validation and understand the regulatory requirements
  • Assess your current organisational strategy regarding the validation of Electronic Healthcare Records
  • Understand how to apply CSV requirements to Electronic Healthcare Records in a hospital setting
  • Plan and undertake a CSV risk assessment, develop a validation master plan, understand the requirements of user acceptance testing and develop a validation report
  • Undertake a high-level gap analysis and initiate the computer systems validation process for key hospital systems


You can find further information on the course here.

Achieving MHRA Phase I Accreditation


I was pleased to hear the news that my previous employer, Guy’s and St Thomas’ NHS Foundation Trust, finally achieved MHRA Phase I accreditation for the NIHR Guy’s Clinical Research Facility.

I initiated this project in December 2013, when I was working as the R&D / NIHR Biomedical Research Centre Quality Assurance Manager. It took almost four years of careful planning and implementation to achieve this incredible milestone. After undertaking a Good Clinical Practice gap analysis, I identified that we needed to develop our quality system considerably in order to be phase I accreditation compliant. In addition, we needed to invest in infrastructure. We had to redesign some of the facility and we also needed to increase staffing levels. This was all to ensure that we had the correct resources needed to be compliant with phase I accreditation guidelines.

In May 2016, we were ready to submit our application to the MHRA. After six months, we received notification that we’d have our first inspection. This was a challenging project but it also felt incredibly motivating for our team to work through these challenges together. It was identified that additional work was required, and after an extra drive in early 2017, we were reinspected in May. I completed the final corrective action preventative action plan over the summer of 2017 and we submitted the final document package to the MHRA in August.

The project was a success due to the fact that we approached it as a team. Everyone involved, from all levels of the organisation, and also our partners at Kings College London, contributed to this amazing outcome. I am proud to have led this project and I’m pleased that we achieved the outcome we worked so hard towards.

I left my role at the end of August to commence my own clinical research consultancy. If you’re interested in undertaking similar work: whether it be a GCP/Phase I gap analysis to see where you are, or a more general quality system review, please get in contact at

You can read more about Guy’s and St Thomas’ exciting news here. If you’re interested in learning more about Phase I accreditation, see the MHRA’s information on the topic.

Paul Cross is a clinical research consultant, specialising in quality assurance, risk management, pharmacovigilance and early phase clinical trial management.

Stop. Relax. Get organised.


Quality management is about continuous improvement. You implement a process, develop a system, observe it and measure it. You identify what works and what doesn’t. You change some aspects and start the process of review again.

However, sometimes things still don’t work out. But that’s how it is in research. This is why we need to document and report deviations. Unexpected things happen, errors occur. The most important thing to do when things don’t work out is to learn from these issues, improve and move forward. It’s not always easy, and sometimes it requires a new set of eyes to be able to see the wood through the trees.

So when things feel like they’re not going well, the best thing to do is to stop. Relax. Then get organised. Break down your workload into manageable, bite-sized chunks. Write a to-do list of the most important five things you need to do this week. Work through the tasks, one-by-one, then when you’re done, stop, relax, and take a moment to praise yourself for a job well done.

The more we break down our work into manageable pieces the easier it is to stay on top of it. This is essential if we’re to stay efficient and motivated in our work, and necessary to avoid overwhelm.

So, next time it all seems too much…

Stop. Relax. Get organised.

It’s a mantra we all need to remember.


Organising your research

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I often get questions about how to effectively implement a quality system within a research department, or to organise a research study so it runs effectively.

It comes up time and time again, so I’ve put together a survey to find out which topics are most important to you. I hope to write a series of blogs and prepare some guidance documents to help you in your everyday work. You can take the survey by clicking here.

With thanks,

Paul Ian Cross