Course Directors & Scientific Committe
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, Ph.D Cristina Valente, Pharm D.
SUMMARY
DESCRIPTION: Running clinical studies is a complex task that requires several skills. Skills ranging from Good Clinical Practice over all 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 achieving success in recruitment objectives and high standards of quality and performance. This interactive 2-day course will provide you a comprehensive knowledge on the practical aspects of clinical studies, essential to reach the highest quality of data whilst ensuring the study participants’ safety and well-being and that your professional knowledge is optimized.
This course is organized in collaboration with the Cardiovascular Research Support Unit / Gabinete de Apoio à Investigação Cardiovascular – GAIC and the National Hub STAND4KIDS.
Course Objectives
With a 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 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 the regulatory framework of clinical trials (from approvals to follow-up activities).
- Describe the different types of clinical research with an 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 for Research teams (Senior and Junior Researchers, from Senior Physicians to Intern doctors, Nurses, Biomedical Scientists, Allied Health Professionals, Study Coordinators) and other professionals with an 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
- Clinical Study: the first contact with researchers and study team
- Patient-centered research
- Interactive Workshop
DAY 1 – Interactive Sessions & Workshop (9am-5pm)
- The Physician as Clinician and Principal Investigator
- Clinical Study Ongoing Activities & Stakeholders
- Audits and Inspections
- Pharmacovigilance
- Interactive Workshop
- Final Exam
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 of 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
IMPORTANT NOTE: Your registration will only be considered valid with the proof of payment sent to us.
- i. Online registration
- Early fee (10% discount): Until 25 September 2022
- Regular fee: from 15th October to 10th November 2022
- For the course will be admitted a minimum of 8 participants.
- ii. Payment
- The payment method will by bank transfer using the following data: Account Holder: AIDFM; IBAN: PT50001800003666547200180; BIC/SWIFT: TOTAPTPL
| Early fee* | Regular fee | |
| Regular fee | 350€ | 400€ |
COMMENTS & INTERVIEWS FROM PAST PARTICIPANTS
“The sessions with practical group examples and the online quizzes, followed by the respective explanations, were really important. I really enjoyed the course. The team is very competent and dynamic – I highly recommend it! Tatiana Silva, Fundação Champalimaud (June 2021).
“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).
Course Satisfaction Survey Report 2022
SCIENTIFIC ENDORSEMENT
PHARMACEUTICAL COUNCIL ACCREDITATION
