Summary
The objective of this course is to provide an introduction to the scientific, methodological, and ethical aspects of clinical trials research, focusing on the practical aspects of clinical studies, essential to reach the highest quality of data whilst ensuring the study participants’ safety and well-being. This course has received scientific endorsement by the Faculty of Medicine, University of Lisbon and the Portuguese Society of Cardiology.
Course Aims
The course provides an introduction to scientific, methodological, and ethical aspects of clinical trials research.
Main learning objectives:
- Provide to 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 the national and international legislation and other standards of reference applicable to clinical research.
- Understand the roles and responsibilities of the different parties involved in clinical research, and the fundamentals of Good Clinical Practice (GCP).
- 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
This course is designed for Health Care Professionals (doctors, allied health professionals, nurses, study coordinators, administrative assistants) with zero to 5 years of experience in clinical research and anyone who would like to learn the fundamentals of Good Clinical Practice and extend their knowledge in clinical research methodology and procedures.
Course Structure
DAY 1 – Interactive Sessions & GCP Training (9am-5pm)
- Types of Studies and Research Design
- Regulatory Aspects
- Clinical Study: the first contact with investigators and study team
- Patient-Centered Research
- Clinical Study Ongoing Activities & Stakeholders
- Pharmacovigilance
- Audits and Inspections
DAY 2 – Workshop & GCP Training (9am -1pm)
- Pharmacovigilance
- Workshop: Tricks & Tips for the Investigators and Study Team
- Closing Remarks
Please click HERE to access the FULL program of the course.
Course Methods
The course is divided in 10 sessions, each covering a specific subject of clinical research with 10-12 hours duration. The lectures will be in Portuguese with support material written in English and will focus on practical aspects of clinical research with examples and quizzes to consolidate knowledge. The course includes an online test at the end of all sessions.
Certificate of Attendance
Upon completion of the course all participants will be awarded a Certificate of Attendance. Participants will also receive an accredited European Good Clinical Practice (GCP) certificate valid for 3 years (official training provider from TransCelerate Biopharma Inc.
Why Should I Do This Course
This course has a strong practical component, with several examples and exercises, that will enhance the knowledge acquired. This training will provide you with the necessary knowledge and tolls to achieve success in recruitment objectives and high standards of quality and performance in clinical research.
General Information
- i. Online Registration
- ii. Fees
- 300€ (includes accredited European GCP certificate valid for 2 years)
- iii. Venue
- Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Av. Prof. Egas Moniz, 1649-028 Lisboa
- Associação para Investigação e Desenvolvimento da Faculdade de Medicina
- iv. Contacts
- Email: info@aidfm-cetera.com (Elisabete Apolinário)
- Tel. +351 217 930 920
Comments 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)
Course 1st Edition @ NEWS
https://justnews.pt/noticias/projeto-inovador-da-apoio-a-investigacao-clinica-em-portugal