What are key Principles of ICH GCP E6 guidelines?
A good clinical practice (GCP) guideline for clinical studies involving human beings is called ICH E6. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was responsible for developing it. The most recent version, ICH E6(R2), was completed in 2016. ICH E6(R3), a new version, is currently being developed and is undergoing public comment.
There are 7 key principles of ICH GCP E6 according to draft version of E6 (R3) Good Clinical Practice (GCP) guideline.
- Ethical Conduct: Clinical trials should be carried out in compliance with the ethical standards that are consistent with GCP and the relevant regulatory requirements and that have their roots in the Declaration of Helsinki.
- Scientific Validity: Clinical trials need to have a strong scientific foundation and be planned to produce solid data that is sufficient to address the research topic and guide decision-making.
- Risk Based Approach: Determine the type, scope, and timing of the activities required to carry out a clinical research using a risk-based approach. The amount of work, formality, and paperwork should be proportionate to the risk the trial poses to the subjects and the caliber of the data.
- Quality Management: To preserve the rights, safety, wellbeing, and anonymity of trial participants as well as the veracity of the data, quality management should be used at all stages of clinical trials.
- Roles and Responsibilities: Clinical trial participants should have roles and duties that are explained and documented with clarity. To carry out their duties effectively and efficiently, they should be provided with the necessary training, resources, and supervision.
- Transparency: Unless there are good grounds for confidentiality, information on clinical studies should be promptly made public. Clinical trial outcomes should be communicated in a precise, comprehensive, balanced, and objective manner.
- Stakeholder Engagement: Stakeholders should be involved at every stage of a clinical trial to make sure that their opinions and expectations are taken into account. Participants in trials, researchers, sponsors, regulators, ethical committees, health authorities, medical experts, patient organizations, and others as necessary are examples of stakeholders.
How does ICH E6 ensure data quality?
ICH E6 ensures data quality by applying the following principles and practices:
- Quality by design: A well-defined research question, proper procedures, and endpoints that are in line with the intended use of the data should all be included in the design of clinical trials.
- Critical to quality factors: The criteria that are crucial for guaranteeing the reliability of trial results and the safety of trial participants should be identified, given priority, and monitored throughout the course of clinical trials.
- Risk proportionate approach: Clinical trials should assess and mitigate the potential risks to data quality, and allocate resources and activities according to the level of risk. The risk assessment should be documented and updated as needed.
- Quality tolerance limits: Clinical trials should establish predefined thresholds for important deviations from the protocol or GCP that may impact data quality, and report and address them in a timely manner.
- Data integrity: Clinical trials should ensure that the data are accurate, complete, consistent, and attributable, and that they are protected from unauthorized access, modification, or deletion.
- Data verification: Clinical trials should verify that the data are collected, recorded, processed, analyzed, and reported according to the protocol, GCP, and applicable regulatory requirements. Data verification should include source data verification, data review, data cleaning, and quality control checks.