Nam Dinh University of Nursing organizes a training course on Good Clinical Practice and ethics in biomedical research and Standard Operating ProcedureNgày đăng: 27/09/2019 16:23
On 27th and 28th September 2019, Nam Dinh University of Nursing organized a training on Good Clinical Practice and ethics in biomedical research and Standard Operating Procedure of the ethics committee in biomedical research.
Good clinical practice (GCP) is an international quality standard for conducting clinical trials that in some countries is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. In the European Union, Good Clinical Practice (Directive 2001/20/EC) is backed and regulated by formal legislation contained in the Clinical Trial Directive (Officially Directive 2001/20/EC). A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
Attending the training course there were MSc. Hoang Hoa Son - Lecturer of the training course, expert of Department of Science and Training, MOH. On the side of NDUN, there were Assoc.Prof. Dr. Le Thanh Tung - NDUN Rector; members of management board, the ethical council members, the lecturers participating in NDUN scientific research.
Speaking at the training course, MSc. Hoang Hoa Son - an expert from the Department of Science and Training - Ministry of Health, emphasized the importance of good clinical practice and ethics in biomedical research and the purpose of the training course is to help researchers design research, comply with and standardize the research process according to GCP principles and improve the quality and scientific objectivity of the research.
On behalf of the University, Assoc.Prof. Dr. Le Thanh Tung expressed his thanks to the Department of Science and Training - Ministry of Health for caring and facilitating the opening of a training course for staffs of Nam Dinh University of Nursing.
The lecturers and researchers of the University attending the training course will have a basic knowledge about clinical good practice and research ethics which are important to help researchers design research with compliance and standards research process according to GCP principles and improve the quality and scientific objectivity of the research.
At the end of the training, participants were tested for knowledge and awarded with certificates by the Department of Science and Training - Ministry of Health.