Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Author:
Oikonomou Evangelia
Supervisors info:
Κωνσταντίνος Ν. Συρίγος , Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Γεώργιος Στεργίου ,Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ανδριανή Χαρπίδου, Ακαδημαϊκή Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Η υιοθέτηση των κανόνων ορθής κλινικής πρακτικής και η αλλαγή που επέφεραν στην διεξαγωγή των κλινικών μελετών
Translated title:
The adoption of the guidelines of Good Clinical Practice and the change they brought about in the conduct of clinical trials
Summary:
The application and adherence to the Good Clinical Practice rules by the
parties involved in the entire duration of the study ensures the protection of
the participants and the quality of the results. The sponsor, the researcher,
the ethics committees, and the regulatory authorities of a clinical study shall
have different responsibilities during the conduct of the study, which they
shall perform based on the Good Clinical Practice rules, as any deviation
from their application may have negative results both for the integrity of the
results and for the safety of the subjects of the study.
The Good Clinical Practice Rules contain the requirements of the study
protocol, with an up-to-date consent, the benefit-risk profile and the
minimization of risks, as well as the process of monitoring and checking the
procedures and documents of a clinical study.
In emergency situations the GCP principles should continue to be applied
by stakeholders who need to speed up proceedings, on condition that the
security of the participants is ensured. An emergency situation for public
health is also the COVID-19 epidemic. Clinical studies in the time of COVID19 presented some alterations, such as adaptation for distance consent
procedure, changes in the distribution of the research product, the protocol
and the monitoring process.
Evidently, all requirements imposed by the Good Clinical Practice rules in
all aspects of the clinical study affect their conduct, making their implementation in emergency situations and their successful compliance of
paramount importance for the public health.
Main subject category:
Health Sciences
Keywords:
Clinical trials , GCP , Guidelines , Good clinical practice
File:
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Oikonomou Evangelia MSc.pdf
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