Clinical Research: What’s it all about? [ 2020 Editions ] Online

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.

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.

This course is organized in collaboration with the Cardiovascular Research Support Unit / Gabinete de Apoio à Investigação Cardiovascular – GAIC and the Cardiovascular Centre of the University of Lisbon – CCUL.

Poster.pdf

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) and other professionals with interest in clinical research, with or without experience in clinical research.

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.

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

Course Final Program.pdf

8th Edition PRESENTERS

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).

Registration , Payment & Contacts

  • i. Online Registration
    • –> Deadline <– 01 October.
    • 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
Normal Fee
225€
300€
CCUL Investigators
-
225€
CAML Investigators
-
225€
SPCCTV Associates
225€
255€

                *8th Ed.: until 31st Aug 2020.

    • The payment method will by bank transfer using the following data:
      Account Holder: AIDFM
      IBAN: PT50001800003666547200180
      BIC/SWIFT: TOTAPTPL
  • iii. Venue
    • Online
  • iv. Contacts

Comments & Interviews From Past Participants

“Thank you so much! Although it was a very first approach to the topic and in a very intensive format, the course excelled for not becoming overwhelming and for being able to retain the essential points. The practical sessions were very important, not only for the consolidation of the given topics but also for the dynamics they created.”
Maria Inês Cunha, Biomedical Researcher, PhD, ICBAS – University of Porto. (October 2020)

“It was very good, thanks! It was only a pity that it was not in person because I think it would have been amazing!”
Marco Ferreira, Coimbra University Hospital (CHUC). (October 2020)

“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 Satisfaction Survey Report 2020

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

Pharmaceutical Council Accreditation

European Accreditation Council for Continuing Medical Education