Do you wish to have a better understanding of clinical research operations? Would you like to sharpen your expertise in academic clinical research? ICN’s comprehensive range of tailored and customized training possibilities will help boost the capabilities of your institute.

Focus lies on Investigator Initiated Trials (IITs). We are glad to offer you a personalized training program. ICN members are competent to share their knowhow in the following fields such as:

  • Overview: Introduction to clinical research
  • Worldwide ethical and regulatory framework (in combination with national regulations, if requested)
  • History of clinical research ethics
  • Good Clinical Practice (GCP)
  • Declaration of Helsinki, other legal regulations on ethics
  • European regulation
  • Regulatory submission
  • Medical device studies
  • Legal specifics: Clinical trials
    • with participants < age of 18
    • in intensive / emergency medicine
    • including gene therapy
  • Good Laboratory Practice, GLP
  • China, including
    • China-specific GCP regulations
    • drug- and medical device development process
  • Germany
  • Swiss
  • Turkey
  • Other associated ICN members
  • One day training: Clinical study design (I) and (II)
  • Clinical study design short
  • Drug development process
  • Clinical phases
  • Interventional and observational clinical research
  • Different designs for special population / fields (rare diseases, pediatrics, etc.)
  • Sponsor
  • Investigator (and site staff)
  • Further clinical research team at site
  • Clinical trial manager
  • Clinical research organizations (academic-commercial)
  • Ethics committee (structure, role, approval processes, benefit/risk rationale, participant rights, evaluation of IC, etc.)
  • Third parties (pharmacy, radiology, pathology, core lab, etc.)
  • Protocol: Conception - writing
  • Informed consent (IC), General consent: History – conception
  • Case report forms
  • Investigators brochure
  • Feasibility questionnaire
  • TMF - ISF
  • Standard Operating Procedures (SOPs)
  • Conflict of interest
  • Preparation of study documents (CSP, IC, CRF, TMF, others)
  • Country selection - Site selection
  • Site feasibility
  • How to apply for funding / research grants
  • Set up of clinical trial budget
  • Site budget and site contract
  • Site initiation
  • Documentation, data entry in CRF
  • Investigational Medical Product (IMP) management
  • Patient screening and inclusion
  • Patient recruitment systems and strategies
  • Clinical operations
  • Protocol compliance: Deviations, violations, note to files
  • Financial management
  • Close out activities and archiving
  • Overview clinical trial management
  • Basic concepts of statistics
  • Methodology to avoid bias (controlled trials, randomization, blinding)
  • Statistical planning and analysis
  • Bioinformatics
  • Randomization tools
  • Data management –overview
  • Electronic data capture (EDC): Software requirements, operation, central elements, software examples (SecuTrial, MACRO, REDCap)
  • System validation process of GCP-compliant software systems
  • CRF: Development, getting from the protocol to the final CRF
  • Randomization
  • Data collection, query management, validation processes
  • Quality and risk management system
    • basic principles, SOPs, further documents
    • requirements, development, maintenance
  • Sponsor´s responsibility: Audits
  • Regulatory Authority: Inspections
  • Monitoring principles
  • Selection /responsibilities of monitor (clinical research associate, CRA)
  • Safety principles
  • Adverse event reporting
  • Safety reporting responsibilities of the Sponsor
  • Medical writing in clinical trials
  • Translational research – regulatory aspects, logistic challenges
  • Biobank systems
  • How to build up a biobank
  • How to set up an academic “Clinical Trial Center”
  • Data exchange among different countries
  • Clinical research terminology

For more details, please contact us at info@icn-connect.org.