What is it? Why is it important?

The ability to conduct studies is largely based on the ability to comply with requirements defined by the EC, the law, including relevant standard (e.g. ISO) and guidelines (e.g. ICH GCP, declarations of Helsinki and Taipei).

Both EC and if applicable Swissmedic will initially evaluate the study and decide whether the study can be approved for implementation.

The overall aim is to ensure that:

  • The safety, rights and confidentiality of study participants are protected
  • The quality and integrity of study data is guaranteed
  • The documentation of the investigational product (IMP/IMD) is available and fulfils quality obligations

In order to ensure that studies are conducted in accordance with given laws, regulations, directives and guidelines, requires that:

  • Both Swissmedic and EC review and approve study proposals, prior to their implementation (e.g. Swissmedic only reviews high risk studies with risk category B and C)
  • Swissmedic performs compliance inspections

What do I need to do?

Aspects to consider are:

  • Scientific validity: the degree to which the study question accurately reflects and assesses the concept a researcher is trying to measure
  • Recruitment: a fair selection of study participants, inclusion of consenting participants, special handling of vulnerable participants
  • Resources: trained and educated study staff, required infrastructure and equipment, sufficient time available to implement the study
  • Risk-benefit ratio: participant safety takes precedence over scientific interest
  • Data handling: Protection and confidentiality of study data, including traceability and protection against damage and loss
  • Handling of biological material: Correct handling, protection against damage and loss, confidentiality of genetic data, infrastructure for long term storage
  • Budget: guarantee financial coverage until study completion, including archiving and possible storage of biological material

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ALLEA European Code of Conduct for Research Integrity – see in particular chapters

  • Chapter 1 Principles
  • Chapter 2 Good research practices

ICH GCP E6(R2) – see in particular guidelines

  • Chapter 2 Principles of GCP
  • Chapter 5 Sponsor responsibilities

ISO 14155:2020 Medical device – see in particular chapters

  • Chapter 5 Ethical considerations
  • Chapter 6 Clinical investigation planning
  • Chapter 9 Responsibilities of sponsor
  • Chapter 10 Responsibilities of PI

SAAS Code of Conduct for Scientific Integrity – see in particular chapter

  • Chapter 4 Implementation of basic principles

SAMS handbook Research with human subjects – see in particular chapters

  • Chapter 2 Research ethics
  • Chapter 4 Scientific requirements
  • Chapter 5 Selection of participants
  • Chapter 6 Assessment of Risks and benefits
  • Chapter 9 Respect for participants
  • Chapter 12 Research with biological material and HRpD

UNESCO’s Universal Declaration on Bioethics and Human Rights – see in particular articles

  • Art. 4 Benefit and harm
  • Art. 8 Respect for human vulnerability and personal integrity
  • Art. 9 Privacy and confidentiality
  • Art. 10 Equality, justice and Equity
  • Art. 17 Protection of the environment, the biosphere and biodiversity
  • Art.20 Risk assessment and management

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD

HRA – see in particular articles

  • Art. 10 Scientific requirements
  • Art. 11 Subsidiarity
  • Art. 12 Risks and burdens
  • Art. 15 Safety and protective measures

ClinO – see in particular articles

  • Art. 3 Scientific integrity
  • Art. 4 Scientific quality
  • Art. 5 Rules of GCP
  • Art. 6 Professional qualifications
  • Art. 17 Handling of biological material and HRpD

ClinO-MD – see in particular articles

  • Art. 4 General obligations of sponsor and PI
  • Art 5. Professional qualifications
Abbreviations
  • ALLEA – All European Academies
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FADP – Federal Act on Data Protection
  • FEDLEX – Publication Platform for Federal Laws
  • GCP ICH – Good Clinical Practice International Council for Harmonisation
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health Related Personal Data
  • IMD – Investigational Medicinal Device
  • IMP – Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • PI – Principal Investigator
  • SAAS – Swiss Academies of Arts and Sciences
  • SAMS – Swiss Academy of Medical Sciences
  • UNESCO – United Nations Educational, Scientific and Cultural Organization
Concept ↦ Ethics and Laws ↦ Study Feasibility ↦ Ethics and Laws
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Study Feasibility ↦ Ethics and Laws

Please note: the Easy-GCS tool is currently under construction.