Application of GCP to the Conduct of Clinical Research

August 2010

The conduct of clinical trials has moved increasingly to a model that involves multiple sites in many countries.  In 1996, the Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed “Guidance for Industry E6 Good Clinical Practice:  Consolidated Guidance” (ICH GCP guidance (E6)).  The goal was to provide guidance that would “provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by regulatory authorities in these jurisdictions.”  As you will note in the title of the document, it applies to “Industry.”  Sponsors often ask JHU and JHM researchers if they will provide assurance that the institution, the IRBs, and the researchers will comply with good clinical practice (GCP) as detailed in the ICH GCP guidance (E6). 

The JHM IRBs operate in accord with ICH GCP guidance (E6) only to the extent that it is compatible with FDA and DHHS regulations.

GCP standards contained in the ICH document are not regulatory requirements in the United States.  JHM IRBs do not voluntarily agree to comply with all of the GCP statements outlined in ICH-GCP guidance (E6), with one exception as noted below. 

Industry-sponsored study with contract requirements for institutional adherence to ICH GCP guidance (E6):

The IRBs will conduct a review in accord with ICH GCP requirements when either the ORA informs OHSR that a sponsor requires it or if the PI selects this option in the eIRB application.  For these studies only, the JHM IRB will confirm that the IRBs were organized and operated during the review according to ICH GCP guidance (E6).  Investigators should be aware that adherence to ICH GCP requires the completion of additional training for study team members, confirmation that all GCP standards will be followed during the research, and the submission of additional materials and information in eIRB to complete the review.

A sample Investigator checklist that research teams at JHM may use when a study is to be conducted in accord with ICH GCP requirements can be found at:  http://www.hopkinsmedicine.org/dev/irb/about/monitoring/toolkit/sample_gcp_checklist.doc .

Under the ICH GCP guidance (E6), the PI is responsible for reporting requirements.  These requirements include reporting the termination or suspension of a research study by the PI, sponsor, or IRB (see, 4.12 at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073122.pdf).