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Sponsor not responsible for compliance of ethics committee
Dr Arun Bhatt | Wednesday, December 6, 2017, 08:00 Hrs  [IST]

Is sponsor responsible for compliance of ethics committee in terms of subject matter expert included in ethics meeting/ approval, compliance of Schedule Y and ICMR guidance?

Vishal nakrani

The sponsor is not responsible for ensuring any specific GCP/Regulatory compliance requirements for Ethics Committee. As per GCP, guidance the sponsor must obtain a statement of compliance to GCP and regulations. See the excerpts below.

ICH GCP 5.11.1 The sponsor should obtain from the investigator/institution:
(a) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.

Indian GCP 3.1.7. Confirmation of review by the Ethics Committee

The sponsor shall obtain from the Investigator(s) and/or the Institutions
(b). An undertaking that the Ethics Committee is organised and operates according to the GCP and the applicable laws and regulations.

What are audit trial requirements for an electronic data capture (EDC)/ eCRF?
Indraneel Kundu
US FDA regulations 21 CFR 11 Electronic records and signatures Section 11.10(e) indicates that "Use of secure, computer-generated, time-stamped audit trials to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trial documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying."

FDA Guidance for Industry Electronic Source Data in Clinical Investigations has the following recommendation for data elements:
  • Each data elements should have data element identifiers that reflect the following:
  • Originators of the data element
  • Date and time, the data element was entered into the eCRF (the audit trial begins at the time the data are transmitted to the eCRF)
  • Clinical investigation subjects to which the data element belongs
  • Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified and/or corrected data elements must have data element identifiers, such as date, time, originator and must not obscure previous entries
  • The role of person making the edits need to be in audit trial
  • A field should be provided allowing originators to describe the reason for the change (e.g., transcription error). Automatic transmissions should have traceability and controls via the audit trial to reflect the reason for the change
US FDA’s guidance on Computerized Systems Used in Clinical Investigations advocates that Access must be limited to authorized individuals (21 CFR 11.10(d)).

To accomplish this, US FDA recommends that each user of the system have an individual account. The user should log into that account at the beginning of a data entry session, input information (including changes) on the electronic record, and log out at the completion of data entry session. The system should be designed to limit the number of log-in attempts and to record unauthorized access log-in attempts.

In a recent EC meeting, a member who was a co-investigator participated in the review and deliberations. The co-investigator was not involved in study design, protocol development, nor authorship rights. Does this qualify as conflict of interest?
Dr Rita Sinha
This situation qualifies as a conflict of interest situation. At initial review of study protocol, the co-investigator would be aware that he/she would be performing some study roles e.g. consenting, recruiting, safety monitoring, data collection if the study is approved. The co-investigator would also be aware that he/she may receive remuneration from the investigator for performing some trial related roles.

As per ICH GCP 3.2.1 only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter.

Considering the above, the co-investigator should have declared his/her role in the clinical trial, and relationship with the investigator before the Ethics Committee began discussions on the protocol and should not have participated in the deliberations.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries


Hasmukh Patel Dec 31, 2017 10:02 PM
When EC invites a subject matter expert for assistance in a clinical trial, the expert can vote for protocol approval of that trial?

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