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According to study protocol, the participant must sign an informed consent form. However, the site has consented 2 participants, who have given thumb impression as the subjects are elderly and cannot write. In ICF narration in source notes, it was mentioned that they can read, write, and understand the ICF signed local language. Is this a protocol and GCP deviation?
Vijay Barve
This is a GCP violation as this informed consent process and documentation is not as per protocol, and GCP guidelines. The protocol doesn’t permit enrolment of illiterate participants. In ICF narration, the site has mentioned that the participants can read, write, and understand the ICF signed local language. However, on the signature page, the participants have put thumb impression. The site has signature of LAR. If the participants are not literate, the site should have taken signature of impartial witness.
The conduct of the site appears towards misconduct as the site seems to have enrolled illiterate participants and given an excuse of old age. But they still document that the participants are literate.
You should conduct a for-cause audit and report the GCP violation to the Ethics Committee and the regulatory authorities. These participants should be excluded from the analysis.
"I’m reading https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sponsor-investigator-irb-interrelationship and trying to discern whether the investigator is required to provide an IRB membership list to the sponsor.
We have sites who are providing Ethics Committee policies which state that they do not provide Ethics Committee membership lists. How does the sponsor ensure compliance with ICH GCP?
Dr Durgesh Kantalia
ICH GCP in the section sponsor requires confirmation of review by IRB/IEC by the documentation as per following:
5.11.1. The sponsor should obtain from the investigator/institution.
a) The name and address of the investigator's/institution’s IRB/IEC.
b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.
c) Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested.
The ICH GCP E6 guidance addresses the essential documents for the conduct of a clinical trial in section 8 of the guidance. Specifically, section 8.2.8 states the IRB/IEC composition should be maintained at the investigator/institution, and at the sponsor, where required, to document that the IRB/IEC is constituted in agreement with GCP. However, there is no specific requirement of obtaining list of EC member. Availability of the statement from the Ethics Committee assuring compliance to GCP and the applicable laws and regulations in the sponsor’s essential documents is adequate to ensure compliance with regulatory requirements and ICH GCP.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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