17 januari: ICH-GCP Flashcards
which actor is missing in the international conference on harmonisation
Physicians. This is worked around by using the declaration of helsinki of the WMA
Can every country join in the ICH?
why would a country would like to join?
Formerly, no. Now its is a council i.p.v. a conference (and therefor a formal legal entity) in which every country can join
Because joined countries can give feedback to new guidelines
The ICH guide line had QSEM topic. What is the E6 and which 4 subtopics does it entail
E topics: Efficacy: is about the clinical trials.
E2a: clinical safety management: definitions and standards for expedited reporting
E6: GCP
E8: General considerations for clinical trials
E9: Statistical Principles for Clinical Trials
What is the ICH GCP?
= ‘Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects.’
What does compliance with this standard provides assurance that… (two fold purpose)
Compliance with this standard provides public assurance that the rights, safety and well-being of
trial subjects are protected, consistent with the principles that have their origin in the Declaration
of Helsinki, and that the clinical trial data are credible.’
The objective of ICH is to provide a (twofold puprose)
‘The objective of this ICH GCP Guideline is to provide a unified standard (…) to facilitate the mutual acceptance of clinical data by the regulatory authorities in [the ICH regions].’
What is the difference in objective between the ICH e6 GCP and the DoH
ICH E6 is ethical and scientific quality standard
DoH is ethical guidelines
What is the content of the ICH
? (chapters(
- terminology
- Principle from physicians (foundation of ICH)
Responsibilities of
- Ethic committee
- investigator
- Sponsor
- what should be in the protocol
- Investigator brochure
- Essentials documents ( prior to trials, during, at the end)
Who is responsible to protect the subjects (alleen voor Tessa, niet voor hoger intelligente wezens)
the ethical committe
whos responsibility is it to protect the safety of the patients and the quality of the data (alleen voor Tessa, niet voor hoger intelligente wezens)
investigator
Who’s responsibility is it to initiate and finance the trails and to analyse thedata (alleen voor Tessa, niet voor hoger intelligente wezens)
sponsor
What are the tasks of the IRB/IEC (4)?
- Review and approving:
- trial protocol
- suitability of the investigators
- suitability of the facilities and site
- suitability of the methods for obtaining informed consent - Conduct audits
What is the composition of the IRB/ IEC
at least 5 members
at least 1 without scientific interest
1 independent from the institution/site
When should the investigator report to the IEC immediately
- Deviations from protocol to eliminate immediate hazard
- changes increasing the risk to subject
- all adverse druge reactions (ADRs) that both serious and unexpected
- new information that may affect adversely or conduct of trial`
What are the principles of GCP
Trial to be conducted in accordance with Declaration of Helsinki, GCP and regulations
Anticipated benefits should justify the risks
Rights, safety and well-being of subjects are more important then interests of science and
society
Adequate (non) clinical information on investigational product should be available to
support purpose of trial
Trials should be described in protocols
IRB/IEC approval of protocol is required
Qualified physician should be responsible for medical care of subjects
All individuals involved in conduct of trial should be qualified by education, training and
experience
