Course “Standard of Good Clinical Practices (GCP) in Research (2022 Edition)”

El Aragonese Institute of Health Sciences adjacent to Aragon Health Research Institute organize of March 21 to April 12, 2022 el Course “Standard of Good Clinical Practices (GCP) in Research (2022 Edition)”.

This course is aimed at professionals from the Aragonese Health System, and/or research staff from the IIS Aragón, who are related to the management of Clinical Trials and/or who carry out or plan to carry out ECM in Aragon.

The maximum number of participants will be 40 people. As this is an online course, students must be familiar with the use of distance learning platforms, as well as have an average level of internet use.

The selection criteria will be:

– HEALTH professionals who belong to a research group.

– HEALTH professionals who wish to start research work.

– Professionals assigned to IIS Aragón research groups not included in the two previous groups who develop clinical research and with preference for emerging groups.

– Pre-registration Order.

In the selection, an attempt will be made to guarantee that the different health sectors of Aragon are represented in the activity.

The Good Clinical Practice (GCP) guide is an international standard of ethical and scientific quality applicable to the design, conduct, registration and communication of clinical trials in which human beings participate. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected in accordance with the principles of the Declaration of Helsinki, as well as ensuring the credibility of clinical trial data.

The objective of this ICH GCP guideline is to provide a single standard for the European Union, Japan and the United States, thereby facilitating the mutual acceptance of clinical data by the regulatory authorities of these jurisdictions.

This guide, published in 1997, has acquired relevance over time, consolidating itself as a mandatory quality standard for the performance of ECM for human use and is currently presented as mandatory compliance by legislation on this matter (both Spanish and European). .

The AEMPS, in the “Investigator suitability document” (Version 10, of December 17, 2018), requests that you attach an updated curriculum vitae that certifies your training in the principles of good clinical practice, your professional experience in clinical trials and patient care.”

For this reason, it is considered important to offer a training activity on GCP Standards to researchers or healthcare professionals who are developing CE or are interested in participating in some CE in the future.

OBJECTIVES :

General objectives

To inform and instruct the participant in the international standards of Good Clinical Practice of the ICH (ICH-GCP) with references to the European Directives and current national regulations.

Specific objectives

• Know the responsibilities of each of the agents who participate in carrying out the CE and other research studies

• Know the basics of EC audits and inspections

• Guide potential independent EC promoters when planning their study and complying with all requirements