BS EN ISO 14155:2011 pdf.Clinical investigation of medical devices for human subjects – Good clinical practice.
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.
This International Standard specifies general requirements intended to
protect the rights, safety and well-being of human subjects,
ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
— define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
It does not apply to in vitro diagnostic medical devices.
4 Ethical considerations
4.1 General
Clinical investigations shall be conducted in accordance with the ethical principles that have their origin in the
Declaration of Helsinki (see Reference 181). These principles protect the rights, safety and well-being of human
subjects, which are the most important considerations and shall prevail over interests of science and society.
These principles shall be understood, observed, and applied at every step in the clinical investigation.
4.2 Improper influence or inducement
The sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any investigator(s) or other parties participating in, or contributing to, the clinical investigation.
All investigators shall avoid improper influence on or inducement of the subject, sponsor, monitor, other investigator(s) or other parties participating in or contributing to the chnical investigation.
4.3 Compensation and additional health care
Compensating subjects for costs resulting from participation in the clinical investigation (e.g. transportation) may be appropriate if allowed by national regulations, but the compensation shall not be so large as to unduly encourage the subjects to participate.
Arrangements for additional health care for subjects who suffer from an adverse event as a result of participating in the clinical investigation shall be made and documented.
NOTE Such arrangements can be subject to national regulations.
4.4 Responsibilities
All parties involved in the conduct of the clinical investigation shall share the responsibility for its ethical conduct in accordance with their respective roles in the clinical investigation.BS EN ISO 14155:2011 pdf free download.