Clinical Research: What’s it all about? [ 2019 Editions ]

Course Directors & Scientific Committee

COURSE DIRECTORS
Inês Zimbarra Cabrita, Ph.D
Francisca Patuleia Figueiras, Ph.D

SCIENTIFIC COMMITTEE
Fausto J. Pinto, MD, Ph.D, FESC, FACC, FSCAI, FASE
Dulce Brito, MD, Ph.D, FESC
Joaquim Ferreira, MD, Ph.D
Catarina Sousa, MD
Cristina Valente, Pharm D.

Presenters.pdf

Summary

DESCRIPTION: Running clinical studies is a complex task that requires many skills ranging from Good Clinical Practice knowledge of applicable regulations up to operational aspects on how to carry out clinical studies. Having a high trained and specialized study team conducting clinical research is the main key to achieve success in recruitment objectives and high standards of quality and performance.

Course Aims

With focus on the practical aspects of clinical studies, the course has the main objectives:

  • Provide to the participants the tools and knowledge needed to successfully achieve quality and high performance in all steps of clinical research.
  • Provide information on clinical research practical aspects, essential to achieve the highest quality data, ensuring the safety and well-being of study participants.
  • Identify all the parties involved in a clinical trial and the main responsibilities associated with each of them (e.g. Sponsor, Principal Investigator, CRO, and Monitor).
  • Understand the roles and responsibilities of the different parties involved in a clinical research, and the fundamentals of Good Clinical Practice (GCP).
  • Understand the current legislation, National and European, and other standards of reference applicable to clinical research.
  • Identify the responsible authorities for approving a clinical trial, their respective timelines for approval, and the documents required for submitting an application for a clinical trial authorization.
  • Understand which the regulatory activities are after the clinical trial approval.
  • Describe the different types of clinical research with emphasis on clinical trials and their phases.
  • Understand the difference between Quality control vs. Quality assurance and Audits vs. Inspections.

Who Should Attend

The course is designed to: Research teams (Senior and Junior Researchers, from Senior Physicians to Intern doctors, Nurses, Biomedical Scientists, Allied Health Professionals, Study Coordinators) with or without experience in clinical research.

Course Structure & Program

DAY 1 – Interactive Sessions & Workshop (9am-5pm)

  • Types of Studies and Research Design
  • Regulatory Aspects
  • Patient-Centered Research
  • Clinical Study: the first contact with Investigators and study team
  • Interactive Workshop

DAY 2 – Interactive Sessions & Workshop (9am -5pm)

  • The Physician as Clinician and Principal Investigator
  • Clinical Study Ongoing Activities & Stakeholders
  • Audits and Inspections
  • Pharmacovigilance
  • Interactive Workshop

Final Course Program.pdf

Course Methods

The course will focus on practical aspects of clinical research with examples and exercises to consolidate the knowledge acquired during the course.

The lectures will be in Portuguese with support material written in English.

Certificate of Attendance

During approximately 14 hours (divided into two consecutive days), participants will acquire skills that will allow them to optimize their performance during the conduction of the clinical studies/trials.
At the end of the two training days, the participants will have a final exam (composed with multiple choice questions).  In order to receive a Certificate of Attendance & Approval in this course, participants should be approved in the final exam (MCQ´s + practical exercises).

Why Should I Do This Course

This course will provide you with the necessary knowledge and tools to achieve success in recruitment objectives, high standards of quality and performance in clinical research.

Registration , Payment & Contacts

  • i. Online Registration
    • Here
    • –> Deadline <– 1 week before the date of the course.
    • For the course will be admitted a minimum of 8 participants and a maximum of 16 participants in each session of the course. The participants will be admitted based on the registration order.
  • ii. Fees
    • Bank Transfer Description:
      CET Course_Your Name_Date of Payment

                   __________________________________________________
                                                   |  Early fee * | Regular fee |
                   Non-members       |      225 €     |       300 €    |
                   CCUL members     |          –         |       225 €    |
                   CHULN members  |          –         |       225 €    |
                   __________________________________________________
                *6th Ed.: until 30th Apr 2019; 7th Ed.: until 10th Aug 2019.

    • The payment method will by bank transfer using the following data:
      Account Holder: AIDFM
      IBAN: PT50001800003666547200180
      BIC/SWIFT: TOTAPTPL
  • iii. Venue
    • Associação para Investigação e Desenvolvimento da Faculdade de Medicina
      Av. Prof. Egas Moniz, 1649-028 Lisboa
  • iv. Contacts

Comments & Interviews From Past Participants

“This course is extremely helpful for every clinician who wishes to participate in clinical research. It allows you to understand all the complexities of clinical research, and definitely helped me improve.”
Pedro Carrilho Ferreira, Cardiologist Consultant at Santa Maria University Hospital, CHLN, Lisbon, Portugal. (May 2017)

“This course has added a fundamental knowledge for the development of my professional activity. A great opportunity to learn more about clinical research.”
Susana Silva, MSc, Study Coordinator at Cardiovascular Research Support Department, CHLN, Lisbon, Portugal. (May 2017)

“The course is structured and very well organized. In order to improve the performance of the research teams, I strongly recommend that this training be given to all its members, namely researchers, monitors, coordinators and even promoters themselves.”
Susana Gonçalves, MSc, Santa Maria University Hospital, CHLN, Lisbon, Portugal. (October 2017)

“It is a very practical course […] A simple and, at the same time, careful and thorough approach was taken in order to acquire the concepts.”
Sara Oliveira, Study Coordinator at CUF Oporto Hospital, Oporto, Portugal. (October 2017)

“It is a very good review of the key point of the GCP to perform a clinical investigation of quality. In addition, the practical examples that are explored  are a good complement to the theoretical parts given and that enhances our knowledge about clinical investigation.”
Daniel Caldeira, Cardiologist at Santa Maria University Hospital, CHLN and Professor of Cardiology at the Faculty of Medicine, Lisbon, Portugal. (October 2018)

“Undoubtedly, the main assets of this training are the experience of all the presenters, who really showed us the various day to day situations. And the practical cases, where we were able to do some hands-on at the end of the theoretical part.”
Cláudia Rodrigues, Study Coordinator at the Rehabilitation Medicine Center of Alcoitão, Portugal. (October 2018)

More Participants interviews

Course Editions @Media
https://justnews.pt/noticias/projeto-inovador-da-apoio-a-investigacao-clinica-em-portugal
https://justnews.pt/artigos/curso-clinical-researh-whats-it-all-about-com-maior-componente-pratica/

Scientific Endorsement

European Accreditation Council for Continuing Medical Education

The 7th Edition of this course has been granted 13 CME points from the European Accreditation UEMS-EACCME® which means that our Course has fulfilled the UEMS-EACCME® quality requirements. CME = Continuing Medical Education.

Pharmaceutical Council Accreditation