The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a collaboration formed by regulatory agencies and industry experts in the Europe, Japan, and the United States. The goal of the collaboration was to harmonize, to form common scientific and technical requirements that can be applied internationally.
The results of the ICH collaboration led to publication of many guidelines for registration of investigational products. One important guideline that ICH published was the Good Clinical Practices (GCP) guideline, which was published in May 1995 as ICH E6 (R1).
This Good Clinical Practices (GCP) document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials.
“Good Clinical Practice [is] a standard for design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.” — ICH Guideline for Good Clinical Practice.
How ICH’s GCP is Used
In the United States
The ICH’s GCP guideline is endorsed by the FDA in the United States. It should be used in addition to the human subjects protections regulations (45 CFR 46) and FDA code of federal regulations (CFR). When there are differences between the regulations, FDA CFR would be the standard of practice.
In the world
ICH’s GCP guideline provides a unified standard for the European Union (EU), Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organisation (WHO). Additional countries are adopting the ICH’s GCP guideline into usage.
Investigator’s Responsibilities from ICH’s GCP
Investigator’s Responsibilities is an important section of the ICH’s GCP. As part of investigator’s qualification, I usually go over this section with the site investigator to ensure that they understand their role and responsibilities. Below are some of the responsibilities for an investigator:
- Have appropriate qualifications and resources
- Provide adequate medical care for any adverse experiences
- Provide IRB with appropriate documents and obtain IRB approval
- Comply with the protocol, deviating only with IRB approval, except in case of emergency
- Follow randomization and blinding procedures
- Obtain and document informed consent
- Inform subjects, IRB, sponsor, and the institution of premature termination
- Ensure the appropriate use of the investigational product at the trial site
- Proper handling, storage and recordkeeping of the investigational product at the clinical site
- Keep case report forms (CRFs) and allowing access to the IRB, monitors, auditors, and the FDA
- Maintain appropriate trial related documents
- Document financial arrangements with the sponsor
- Provide progress reports to the IRB at least annually
- Report significant changes to the sponsor and IRB
- Report adverse experiences to the sponsor and IRB
- Produce final reports
- Retain the records and reports for 2 years after a marketing application is approved; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA has been notified
Clinical Trial Monitoring Under ICH’s GCP
ICH’s GCP describes the need for clinical trial monitoring as one of the important responsibilities of the sponsor. ICH’s GCP requires that clinical trial monitoring are conducted to ensure that:
- The rights and well-being of human subjects are protected
- The reported data are accurate, complete and verifiable
- The conduct of the trial complies with the protocol, GCP, and regulations
Identification, correction, and prevention of problems in the above areas are part of the work required as CRAs conduct monitoring visits.
ICH Website and Important Links
ICH’s Website – http://www.ich.org/
ICH Guideline for Good Clinical Practice E6(R1) –
- Country Specific Regulations – Global / International Trial
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Historical Events behind Current Regulations