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GCP First Level Investigator (R3) – PART 1/2 – SPRING 2025 (ENG)

14 Marzo 2025 / 8:30 - 16:00

The GCP Investigator Level course is a two-day programme that follows the new learning objectives set by Swissethics and the GCP guideline amendments; it has therefore been recognised by the Ethics Committees for Research on Human Beings themselves (www.swissethics.ch).

The GCP First Level Investigator is dedicated for Principal Investigators, Research Nurses and others involved in clinical research.

 

First part – March 14th 2025

Second part – March 21st 2025

Modality:

  • In presence – Face to face
  • Final test – Online

Objectives:

  • Understand the importance of research conducted on humans to the progress of biomedical science and public health
  • Understand the importance of protecting participating subjects through appropriate study design and conduct
  • Acquire the basic principles of protection of subjects involved in research
  • Be familiar with research ethics reference documents, including current Swiss regulations
  • Understand the potential impact of fraud, scientific misconduct, and conflicts of interest, and know about prevention/limitation measures
  • Be able to apply the basic rules of research ethics to specific concrete situations
  • Know the investigator’s responsibilities to protect the subjects involved and how to ensure their protection

Program 14.03.25

  • 08h30

    Welcome and introduction

    Prof. Dr. med. Anastasios Stathis

  • 08h45

    Research in human beings

    • What “research” means
    • What “research in human being” means
    • Methodology and different types of studies

    A. Stathis

  • 09h30

    Basic ethical principles of research in human beings

    • What “ethics” means and development of ethics in research
    • Protection of subjects/participants involved
    • Basic ethical principles:
      • Ethical evaluation
      • Scientific soundness
      • Risk-benefit assessment
      • Autonomy of subjects/participants/ informed consent
      • Justice (examples)
      • Risks
      • Vulnerable populations
      • Confidentiality/ privacy
      • Social/ religious/ cultural factors
      • Key ethical documents

    B. Gai

  • 10h15

    Legislation

    • Swiss Research legislation involving Human Beings

    B. Gai

  • 11h00

    Coffee Break

  • 11h15

    Structure and content of the ICH-GCP Guidelines

    • International Conference on Harmonization: History and goals
    • Principles and content of the guideline ICH-GCP
    • Integration into regulations
    • ISO14155 for medical devices
    • Other guideline ICH

    G. Dal Pra

  • 12h00

    Roles and responsabilities of all those involved in research

    • Investigator (particularly in the protection of participating subjects)
    • Other research participants: sponsors, ethics committee, competent authorities, participating subjects, investigators/sponsors

    G. Dal Pra

  • 12h45

    Lunch Break

  • 13h45

    Collaboration with the Ethical Committee

    • Classification of studies according to Swiss law
    • Procedure for applying for a clinical trial/research project approval
    • Multicentric studies and Coordinating Center/Directive Committee
    • Other obligations to the Ethics Committee
    • Registration of studies

    M. Gutacker

  • 14h45

    Particular ethical and legal aspects of clinical trials

    • Improper conduct and fraud
    • Conflicts of interest

    A. Stathis

  • 15h15

    Coffee Break

  • 15h30

    Subject information and informed consent

    • The informed consent process
    • Rights of participants, responsibilities of research personnel, importance of language
    • Definitions, content, and structure of information and consent forms
    • Consent in emergency situations and vulnerable subjects
    • Change management, renewal of consent
    • Implications of offering incentives to participants
    • Data confidentiality

    A. Stathis

  • 16h15

    End of Course

Program 21.03.25

  • 08h30

    Course begins

  • 08h30

    Investigational product (IMP) (Drug and medical device)

    • Handle, store and document study medication and investigational medical devices according to the manufacturer’s and legal requirements
    • Drug labeling
    • Drug/device accountability and shipment records

    A. Stathis

  • 09h15

    Protocol of study and its meaning

    • Structure and content
    • Importance of consistency and comprehensibility of information
    • Protocol adherence
    • Good practice of handling protocol amendments

    A. Stathis

  • 10h00

    Safety

    • Classify, document and report Adverse Event according to protocol and regulatory requirements
    • Responsability of research personnel

    E. Porro

  • 10h30

    Coffee Break

  • 10h45

    Basic statistical concepts

    • Different designs and objectives in research
    • Hypothesis testing
    • Parameters and distributions
    • Sample size calculations
    • Power, Confidence intervals
    • Measures to avoid bias and confounding, blinding and randomisation

    A. Pagnamenta

  • 12h15

    Lunch Break

  • 13h15

    Monitoring

    • Types of monitoring visits and verification of original data
    • Monitoring plan and reports
    • Risk-adapted monitoring

    G. Dal Pra

  • 13h45

    Quality of data

    • Source Data, CRF, Audit trail, Queries
    • Good documentation practice
    • Anonymization and codification
    • Regulations and requirements for collection and archiving of biological data and samples

    G. Dal Pra

  • 14h45

    Coffee Break

  • 15h00

    Transparency and reproducibility of procedures and documentation

    • Essential Documents
    • Archiving
    • Handling amendments
    • Reports to ethic committees and competent authorities
    • Purpose and main concepts of quality control and quality assurance SOPs (standard operating procedures)
    • Audits, inspections

    G. Dal Pra

  • 16h00

    End of Course

Registration

TITLE: GCP First level Investigator

DATE: March 14th and 21st 2025, 08h30-16h00

ROOM: Aula A3.09, USI Campus Est Lugano, Settore A, Facoltà Scienze biomediche

    Cognome

    Nome

    Professione e Luogo

    Email

    Indirizzo postale Privato (per Fatturazione)

    * Tutti i campi sono obbligatori

    The course tuition fee is CHF 400.- for employees of the Ente Ospedaliero Cantonale and its partners and CHF 650.- for external.

    The course is free of charge for PhD students enrolled in one  of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and UZH who present a valid student ID card. Registration is still required.

    By the registration deadline, invoices of the tuition fees will be issued by the Central Accounting and Billing Service (SCCF) of EOC.

    Collaborators of the Ente Ospedaliero Cantonale who wish to be reimbursed by their department are kindly invited to make an (electronic) request to EOFORM for authorization.

    In case of cancellation announced less than 2 weeks prior the registration deadline, the fee will be fully requested.

    Registration must be sent by february 28th, 2025.

     

    For more information:

    clinicaltrialunit@eoc.ch

      Dettagli

      Data:
      14 Marzo 2025
      Ora:
      8:30 - 16:00
      Categoria Evento:

      Luogo

      Aula A3.09 Campus Universitario USI/SUPSI – Settore A
      Via la Santa 1
      Viganello, Svizzera 6962       + Google Maps

      Organizzatore

      AFRI EOC
      Visualizza il sito dell'Organizzatore