The current “Good Clinical Practice=GCP” professional guideline (based on ICH E6 R2) is an ethical and scientific quality system for clinical trials in humans. To ensure mutual acceptance of quality assurance and training, university accreditation is required for the acceptance of training, the minimum requirements for which should be laid down.
Background:
A prerequisite for the approval of domestic clinical trials is that the investigators have successfully completed the GCP course organised (approved, advertised) by the universities and that the applicant has a certificate to this effect. Where the GCP course is not organised by a university, authority or professional scientific society, there are concerns about whether it meets international and national requirements. The OGYÉI and the ETF CPVO rely on the accreditation of universities for the verification of GCP diplomas. Where GCP courses are possible (may be accredited) which are “educational” but do not meet the requirements for domestic investigators, it should be stated in the advertisement and in the diploma that completion of the course does not constitute completion of the GCP course required for domestic clinical pharmacology studies.
Scope:
The regulation covers GCP courses accredited by domestic medical universities.
Objective:
Standardisation of minimum training requirements, allowing for the recognition of courses at national and international level.
Course duration: minimum 8×45 minutes, but 16×45 minutes is recommended to cover relevant professional updates in order to acquire internationally competitive knowledge
Professional minimum:
To meet the professional minimum criteria for the training, the GCP course must include the following chapters:
GCP general overview, definitions
- Good Clinical [Research] Practice (Good Clinical Practice) – 1.24
- Investigator – 1.34
- Subinvestigator – 1.56
- Sponsor – 1.53
- Investigator site definition
- Adverse Drug Reaction (ADR) – 1.1
- Adverse Event (AE) – 1.2
- Serious Adverse Event (SAE) and Serious Adverse Drug Reaction (Serious ADR) – 1.50
- Documentation – 1.22
- Informed Consent – 1.28
- Investigational Product – 1.33
- Investigator/Institution – 1.35
- Investigator’s Brochure – 1.36
- Original Medical Records – 1.43
- See Source Documents (1.52)
- Protocol – 1.44
- Source Data – 1.51
- Source Documents – 1.52
- Subject/Trial Subject – 1.57
- Trial site – 1.59
- Unexpected Adverse Drug Reaction – 1.60
- Vulnerable subjects – 1.61
ICH GCP (Good Clinical Practice) principles
- Regulatory requirements deriving from the Declaration of Helsinki – 2.1
- Weighing the expected benefits and risks of research – 2.2
- Rights, safety and welfare of subjects are the most important considerations – 2.3
- Non-clinical and clinical information on the IMP – 2.4 – 2.11
- Data management of subjects – 2.11
Investigators
- Investigator qualifications and approvals – 4.1.
- Adequate resources – 4.2.
- Medical care of subjects – 4.3.
- Liaison with the Institutional Review Board (IRB) – 4.4.
- Compliance with the protocol – 4.5.
- Study product(s) – 4.6.
- Randomisation procedures and elimination of blinding – .7.
- Informed consent of subjects – 4.8.
- Records and reports, Retention period of documents (§ 24 of the Regulation) – 4.9
- Security reports -4.11.
- Premature termination or suspension of the investigation – 4.12.
Ethics Committees
- Central and Regional Ethics Committees: ETT-KFEB, ETT-TUKEB, ETT-HRB, ETT-RKEB
- Institutional Research Ethics Committee (IREC)
Public authorities and legislation
- Hungarian legislation:
- 1997 CLIV Act on Health Care (hereinafter: Eütv.) Chapter VIII
- Government Decree No. 235/2009 (20.X.) on the rules of the authorisation procedure for medical research involving human subjects, clinical trials of investigational medicinal products for human use and clinical trials of medical devices intended for clinical use in human subjects (hereinafter: Kr) § 3, § 13, § 15, § 16, § 17, § 23, § 29, § 30.
- Decree No 23/2002 (9 May 2002) of the Ministry of Health on medical research on human subjects § 1, § 3, § 4, § 5, § 6, § 8.
- Decree No 35/2005 (VIII.26.) on the clinical investigation of investigational medicinal products for human use and the application of good clinical practice § 4, § 5, § 6, § 7.
- Act XCV of 2005 on medicinal products for human use and amending other acts regulating the pharmaceutical market (hereinafter: Gytv.) § 3.
- OGYEI website
28/2014 (IV. 10.) EMMI Decree on the Scientific Council for Health https://uj.jogtar.hu/#doc/db/1/id/A1400028.EMM/
- EU legislation, directives:
- COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
- Guideline on good pharmacovigilance practices (GVP),, 15. Module VIII – Post-authorisation safety studies
Other recommended professional content:
- Current trends in drug development
- special cases of clinical trials, e.g. medical devices, in vitro diagnostic devices, advanced therapy products
- description of common problems in clinical trials
- data protection
College of Health Professionals
Clinical Pharmacology Section
