ePortfolio, curriculum & decision aids

Regulation of clinical pharmacology and therapeutics (CPT) training is by the Joint Royal Colleges of Physicians Training Board (JRCPTB). This is on behalf of the three Royal Colleges of Physicians.

CPT training follows the same model of assessments as medical training. Work based assessments (WBAs) and learning events are mapped to the curriculum through the ePortfolio. Success is measured through the Annual Review of Competence Progression (ARCP) system.

Curriculum and ARCP decision aids

The CPT curriculum is split into three areas:

  • Common Competencies
  • Clinical Pharmacology Core Modules
  • Clinical Pharmacology – Advanced Specialist Modules

Common competencies are identical to those in the General Internal Medicine (GIM) curriculum.

Certificate of Completion of Training (CCT)

You must show that you have covered all core modules and at least one advanced module. You can find information on how to do this in the ARCP decision aid.

You will dual accredit with GIM, although other dual specialty training programmes are possible.

Project Based Discussions (PbDs)

PbDs reflect that the CPT workload involves less clinical time than other specialities. It assesses non-clinical elements such as:

  • projects relating to research
  • analysis
  • guideline development

Documentation for PbDs is in three main parts:

i) General
  • a. Module items covered
  • b. Description of project
ii) Reflective comments
  • a. What did you do?
  • b. What supporting documents are available (evidence)?
  • c. What have you learned from this project?
  • d. How does this project fulfil the requirements of the modules or items listed?
iii) Assessors comments
  • a. Summary of what was described and the evidence to support this
  • b. Was the evidence presented satisfactorily?
  • c. Does the project fulfil the requirements of the modules or items listed?
  • d. Key points covered in the discussion
iv) Future development
  • a. Suggestions for development
  • b. Agreed action

PbDs need more detail compared to other assessments. You should have considered suitable content before sitting down with your assessor.

We have compiled the following examples of suitable projects from existing trainees:

Clinical Pharmacology Core Module

Clinical Pharmacology – Advanced Specialist Area Modules

Assessing Clinical Pharmacology literature

Guideline development

I developed a local guideline for the assessment of ‘Blood Pressure Variability Disorders’. This project involved identifying and reviewing published literature, and judging which topics were most important for inclusion on the basis of prevalence and/or importance that the diagnosis was not delayed. The guideline underwent peer review at the hypertension MDT and now forms part of the diagnostic framework used by trainees in a tertiary hypertension clinic.

Review articles (or MD/PhD Thesis introduction chapter)

As part of my PhD studies, I studied the impact of intracellular pH (and the drugs that affect it) on vascular biology. For my introduction chapter, I assessed the literature around the topic.

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Use of statistical techniques pertinent to Clinical Pharmacology

PhD project

I used various statistical techniques to analyse the experimental results of my PhD project on The Impact of the Blood Pressure Associated Genetic Locus at SLC4A7 on Gene Expression and Intracellular pH Regulation.

Review of adverse event clinical data from a phase I clinical trial and design of mitigation pathway for phase II study

I reviewed adverse event data from a phase I clinical trial. This involved undertaking causality assessment for each subject using photographs, histopathology and clinical trial data. Based on this data a protocol for the phase II study was developed to determine pathophysiology (e.g. collection of skin biopsy and specific histopathological analysis) and management of future toxicity events.

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Mechanism of drug action

Molecular research in “Intracellular pH and cardiovascular disease”

As part of my PhD studies, I studied the impact of intracellular pH (and potentially the drugs that affect it) on vascular biology.

Involvement in specialist clinics

I gained exposure to pharmacology and prescribing through my involvement in specialist clinics. This opened up the opportunity for a PhD in designing a new protocol for multi-drug intolerance in hypertension.

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Dosing regimens

Pharmacokinetics

I designed learning materials on the pharmacokinetics for the various routes of medicines administration.

Review of drugs for local drugs and therapeutic committee

I sit on the drugs and therapeutics committee at my hospital. In this role I am often asked to review applications for new additions to the hospital formulary. This requires a review of the drug and the literature pertinent to its use as proposed in the application from a safety and efficacy perspective. I review the proposed place in therapy, dose to be used and likely concomitant therapies. I present the results of my review and a recommendation to the committee.

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Rational prescribing - individuals

Adverse event in clinical trial

This involved review of an investigational medicinal product (IMP) targeting inflammation and osteoclasts in patients already receiving methotrexate therapy, to understand pharmacokinetics and safety. It was noted that a patient had a low white cell count and neutrophil count on day three. I reviewed the investigation brochure (IB) to determine if this was an anticipated risk based on pharmacological action of the drug and had further discussions with the principal investigator and medical monitor regarding the patient’s continuation in the clinical trial. The patient was cleared to continue but on day 6 the white cell count and neutrophils had fallen further. The patient was withdrawn from the study due to an adverse event (AE) and referred to a rheumatologist. I was involved in the discussions around causality and in the completion of trial AE paperwork.

Development of a pharmacology curriculum for undergraduate students

I developed a set of seminars and lectures with a consultant colleague, to be delivered across the health board to undergraduate students whilst on placement. These covered key areas of prescription, pharmacology of common drugs and common prescription errors.

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Rational prescribing - population

Review article on pharmacogenetics

I co-wrote a peer-reviewed review on the impact of genomics on hypertension management, where I contributed to the molecular and pharmacogenetics aspects of the review.

Pharmacology Essay Prize

I coordinate an undergraduate prize essay on pharmacology. This particularly centres on prescribing on population levels with regards to pharmaco-economics and ethics.

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Drug regulation

Participation in New Medicines Group

I presented at the New Medicines Group which is part of the All Wales Medicines Strategy Group (AWMSG). I prepared a short presentation detailing the main issues around the medication including analysis of efficacy and cost effectiveness.

Publication on the drug supply chain

I contributed to a publication discussing the role of the independent regulator when the drug supply chain is broken.

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Pharmacoepidemiology

Epidemiological study

I contribute to an ongoing epidemiological study reviewing prescription of gabapentinoids and its relation to self-harm.

Regional Guidelines Review

I wrote a literature review and updated regional guidelines for the management of primary hypertension and hypercholesterolaemia.

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Adverse drug reactions

Approval for clinical trial

I have been involved in securing the ethical and regulatory approval for a First-In-Human clinical trial. This involved analysis of potential adverse drug reactions.

Course and exam design for prescribing

I work on the Prescribing Safety Assessment, and the associated teaching at the local university. Adverse drug reactions play a large part in the assessment.

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Drug errors

​Prescription Audit

I contributed to an audit reviewing inpatient insulin prescription and hypoglycaemia management, implementing updated paperwork and re-auditing.

Allergy Documentation Audit

I was part of a team that audited the consistency of allergy documentation across patient notes, electronic notes and paper drug charts, to reduce potential for drug errors.

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Drug overdose

Research on toxicology placement

I undertook research whilst on toxicology placement and wrote up a case series on atypical presentation of overdoses.

Toxicology placement

I undertook a week long placement in a toxicology unit which involved assessment of toxicology patients, ward rounds and multidisciplinary team meetings. I had the opportunity to review local protocols and observe NPIS telephone calls and was involved in the weekly review of all NPIS calls. I also gained experience in writing a toxbase entry for a new drug and made a visit to the Yellow Card centre.

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Hypertension

British Pharmacological Society Hypertension Training Day

I ran a Hypertension Training Day for StRs. I produced a programme that covered all curriculum areas and organised speakers, venue and catering.

NEJM SPRINT Data Analysis Challenge

I was a participant of the SPRINT Challenge, a competition that involved analysis of a dataset underlying an article from the New England Journal of Medicine on hypertension. I applied for access to SPRINT data through BioLINCC, applied to the NHS Research Ethics Committee for approval and completed the Research Materials Distribution Agreement. I undertook data analysis for both the Qualifying and Challenge rounds, answering a research question and submitting a novel clinical finding.

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Clinical toxicology

Analysis of tramadol overdose across Europe

I analysed data collected by the European Drug Emergencies Network (Euro-DEN) project in collaboration with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Data were collected from 20 emergency departments across 15 countries, and I was tasked with analysing the pattern of presentation and outcomes of overdose that involved tramadol. This project principally involved database manipulation, statistical analyses and report writing.

Treatment of raised creatinine kinase in poisoning

I collected data on the treatment of patients with raised creatinine kinase on admission to the local poisons unit. I analysed the data and this was presented at the national Continuing Professional Development day for the National Poisons Information Service (NPIS).

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Research

Systematic review publication

I completed a systematic review paper reporting the association between HLA-A*31:01 and carbamazepine hypersensitivity reactions. This paper involved me undertaking a literature review and critically appraising the papers. I learned to understand odds ratios, significance levels and characteristics of diagnostic tests (sensitivity, specificity, PPV, NPV and NNT). I was first author for the manuscript, reviewed changes by peer reviewers and submitted for publication.

Review of eligibility criteria for an early phase clinical trial

Following enrolment of a subject into the trial, review of eligibility criteria showed there was possible interaction between simvastatin and the investigational medicinal product (IMP), as both are metabolised by CYP3A4. This was discussed with the medical monitor, principal investigator and chief investigator and the pre-clinical data was reviewed to determine inhibitory concentrations. The patient was dosed after the IC50 had been calculated and a sufficient safety margin determined.

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Clinical Trials Research

Risk assessment and management strategy for a novel investigational medicinal product (IMP) in medical oncology as part of a phase III clinical trial

Before the trial could be conducted at the clinical research unit I completed the clinical risk assessment (eg starting dose, potential safety issues and mitigation, appropriateness of dose escalation protocol). This involved reading the investigator brochure and clinical trial protocol. After completing the risk assessment, I presented the findings to the experimental medicines group.

Clinical study of UMOD NKCC2 interaction in hypertension

My role in this study involved: communication with MHRA regarding non-CTIMP status of trial; writing of protocol, PIL, consent forms, letter to GP and participant invites; application to REC and NHS R&D via IRAS; response to REC comments/requirements and updating paperwork; attendance at REC review meeting; communication with PV officer; writing of eCRF and communication with Robertson Centre for Biostatistics regarding building of eCRF, review and approval; working with University of Dundee to create a patient website and carry out initial screening/consent; organisation of the investigators meeting; purchasing of BP devices for trial; and organisation of research passports for non-clinical members of the study team.

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