In the first update to Good Clinical Practice E6 since 1996, Release 2 introduced 26 major additions to the gold standard for the conduct of clinical research. Release 2 was finalized in November 2016, sites and sponsors must now must bring themselves into compliance with the changes this year.
GCP E6 Release 2 was crafted in response to the increasing use of technology in clinical trial design, conduct and reporting. In addition to the modernization of the guideline, release 2 integrates guidance in response to over 20 years of global regulatory / GCP audit findings.
Investigator oversight has been a common audit finding over the past 20 years. Good Clinical Practice clearly states that the investigator maintains ultimate responsibility for the conduct of the trial at the site. Release 2 goes one step further and clearly spells out guidance for investigator oversight, notably on process and documentation requirements.
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Additions to Good Clinical Practice- November 2016 Release
4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates trial related duties and functions conducted at the trial site.
4.2.6 If the investigator / institution retains the services of any individual or party to perform trial related duties and functions, the investigator / institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
Release 2 now clearly states that prior to delegation the investigator must ensure that any individual is “qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.”
We also see the important addition of implementation of procedures of investigator oversight. Clinical research sites should now have a clear process or procedure, documented in an SOP, that outlines investigator oversight at their site. This should include a process for documentation of all trial related discussions between investigators and delegates.
Furthermore, release 2 extends this oversight to services of parties which may be external from the immediate delegates. Examples of this may be medical imaging, local labs or pathology at an institution. Release 2 clearly spells out that investigators are now responsible for oversight of these groups and the process for this oversight must be documented.