The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the updated version of the Good Clinical Practice (GCP) guidelines in November 2016, known as
Some of the key updates in ICH-GCP E6 R2 include:
Risk-based approach: The updated guidelines emphasise the importance of a risk-based approach to clinical trial design and conduct, with an emphasis on identifying and mitigating risks to patient safety and data quality.
Quality management: The guidelines now require the use of a quality management system (QMS) to ensure that clinical trials are conducted in accordance with GCP standards and applicable regulations.
Investigator responsibilities: The updated guidelines clarify the responsibilities of investigators in ensuring that clinical trials are conducted in compliance with GCP standards, and emphasise the importance of investigator training and oversight.
Electronic systems: The guidelines now provide specific guidance on the use of electronic systems in clinical trials, including requirements for data security, data integrity, and electronic signatures.
Informed consent: The updated guidelines emphasise the importance of obtaining informed consent from study participants, and provide guidance on obtaining consent from vulnerable populations, such as children and individuals with cognitive impairments.
Monitoring: The guidelines now require risk-based monitoring, with a focus on critical data and processes, rather than a one-size-fits-all approach to monitoring.
Safety reporting: The updated guidelines provide more detailed guidance on safety reporting requirements, including the requirement to report adverse events and serious adverse events in a timely manner.
Overall, the updates to ICH-GCP E6 R2 aim to improve the quality and efficiency of , while also ensuring that patient safety and data integrity are protected.
