Person in Charge of the Study
Person in Charge - Required by the Medical Research Act
In Finland, all medical research projects need to have a person who is appointed Person in Charge of the Trial (or person responsible for the study) and referred to into all submissions and permissions. The Person in Charge (in Finnish terms TVH, tutkimuksesta vastaava henkilö) of a medical research in human subjects, i.e. clinical trials with medicinal products, must be a medical doctor or dentist with adequate professional and scientific qualifications.
The Person in Charge is responsible for ensuring that all necessary equipments, tools, safe conditions and qualified study personnel are available for the trial. Additionally, the Person in Charge is obliged to ensure that the study will be conducted in accordance with high ethical standards, Medical Research Act, GCP, Clinical Research Directive, and other rules, acts and guidelines that govern medical research. The Person in Charge has the overall responsibility for study subject safety during the trial and he/she is obliged to undertake precautionary measures to protect study subjects, to inform the Ethics Committee immediately in case of new emerging safety information during the trial, and to suspend the study immediately if required for safety reasons.
In addition to having the overall responsibility for appropriate study conditions and safety elements, the Person in Charge shall make a written assessment of the ethical aspects of the study, with regard to the objectives, study design, risks and benefits, that is included in the Ethics Committee submission. After the trial has been completed, the Person in Charge prepares a separate report on the safety of study subjects as an additional document to the Annual Report submitted to the Finnish Medicines Agency (FIMEA).
If the study in questions is not a clinical drug trial but of some
other nature, also other competent persons besides medical doctors or
dentists may be responsible for the study provided that the said person
has the professional and scientific qualifications required for the