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MeDiNova Research Announces Accredited Clinical Trials Training for Physicians and Nurses - In a Nutshell

MeDiNova Research
Posted on: 11 Mar 18

"There has been no accelerated route of training to become a clinical research physician or nurse to meet the growing demand in the clinical research industry. today are proud to share with the clinical trials community the fruit of our labour."

Kumar Muthalaggan OBE, MeDiNova Research CEO

 

Following on from the success of a pilot programme, accredited by the Health Professions Council of South Africa, pioneered by Dr Mohammed Siddique Tayob, Managing Director of MeDiNova's operations in South Africa, MeDiNova MERC South Africa; Mr Kumar Muthalgappan OBE, MeDiNova Research's Global CEO, and Dr Essam Abdulhakim, Chief Medical Officer, are incorporating this programme across MeDiNova Research's global operations.

This programme has been accredited by the British Faculty of Pharmaceutical Medicine and is worth 21.5 CPD points.

Introduction

Pharmaceutical Medicine as, defined by the faculty of Pharmaceutical Medicine, is “the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of the marketing of medicines for the benefit of patients and the health of the community”. Prior to securing a post in pharmaceutical medicine, health care professionals have had little or sometimes no experience or exposure to the practices involved in clinical trials.

See Full Curriculum Details Here

Programme Aims

This programme is intended to equip the new research Physician/nurse with the knowledge, skills and behaviours required for safely and efficiently conducting the clinical trials and to practise to the highest ethical standards.

The programme is intensive and includes a variety of teaching, learning and assessment methods. The guiding principles used to design the programme were:

 Be evidence-based and developed using sound educational theory

Be predominantly learner-centred using EBL (enquiry based learning), TBL (Team based learning) and PBL (Problem based learning)

It is more contextualised as we can build in teaching activities relevant to future practice and preparing trainees for their future practicing role as a research physicians and research nurses.

The programme team took a ‘design-backwards’ approach to designing this programme. Programme outcomes were drafted from the consideration of the standpoint of “what does a day one research physician and research nurse need to be able to do in their practice”? 

Programme Learning Outcomes

The programme is presented to trainees as 10 sessions. It is designed around the following learning points:

  • Life Cycle of a clinical trial
  • Drug development and trial phases
  • Trial design
  • Regulations of Clinical Trials
  • Authorities including REC and Regulatory authority
  • Roles of Study team
  • Safety measurements including safety reporting
  • Informed consent
  • Protocol and investigator brochure
  • Essential documents
  • Source documentation, CRF and good documentation practices
  • Investigational product
  • Patient recruitment and retention
  • Monitoring visits
  • Audits, inspections and misconduct
  • Mandatory training/recording training
  • Terminology used in clinical trials
  • Principals of quality in clinical research
  • Clinical Trials Outside the Nutshell

This structured training programme is supplemented by pre-course reading and research and post-course assessments

Learning and Teaching Strategy

Students will develop the knowledge, understanding and skills necessary to meet the learning outcomes of the programme through a blended approach

Variety of learning methods will be used to ensure that the trainees will achieve the competencies described in the curriculum

Seminars and group tutorials will be used to reinforce and discuss the application of knowledge

The following teaching/learning methods will be used to identify how individual objectives will be achieved:

  • Team based learning (TBL): There is evidence that students learn more effectively when they learn collaboratively where they can actively engage in collaborative discussion and problem solving. TBL has been shown to have better comprehension, retention of information, critical thinking and attitudes. The students are grouped in small groups (5-7). The Individual Readiness Assurance Process Test (iRAT) where the students answer 10-20 multiple-choice questions individually. The same test is completed in teams, Team Readiness Assurance Process Test (tRAT). Subsequently, the class time is used to practice applying the knowledge acquired during the application exercises. The backward design approach of TBL enables to identify the proposed learning outcomes. One tutor can run several study teams in TBL, whereas in PBL each small group is run by one tutor (Dolmans et al., 2015) 
  • Problem based learning (PBL)
  • Seminars and group tutorials
  • Independent self-directed learning
  • Lectures and small group teaching
  • e-learning

A session called “Reflection on learning experiences” using Gibb's reflective cycle, will be carried out at the end of the programme in order to develop the student understanding of the course content

Assessment strategy

Assessment encourages students to combine elements of their learning from different parts of a programme and to show their accumulated knowledge and understanding. Final programme assessments are assessed through:

  • Extended Matching Questions (EMQs)
  • Multiple choice questions (MCQs)
  • Individual Readiness Assurance Tests (iRATs) and Team Readiness Assurance Tests (tRATs)

Students will receive regular and timely feedback on the development of their knowledge and skills through application exercises and immediate feedback on Readiness Assurance Tests (RATs) using IF-AT cards (Immediate Feedback Assessment Technique)

See Full Curriculum Details Here

Editor's Details

Dr Essam Abdulhakim
MeDiNova Research
www.medinovaresearch.com
eabulhakim@medinovaresearch.com

Last updated on: 11/03/2018

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