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EC Minutes Review by Sponsor CRO 发布时间:2016-06-12

Question 1:

I was hoping to get FDA's perspective on request by a sponsor/CRO to review the meeting minutes of EC. Is this OK/allowed?

We have a lot of family-owned hospitals whose personnel are part of EC in India. Sometimes we have our doubts if the EC is indeed meeting in reality.

Therefore, was hoping if our CRA, who visits the sites and does not have the confidence of EC oversight, may be we should review the quorum/meeting minutes?

I know that in Australia, some ECs refuse to even share the name of members and minutes. Can we do anything about these issues?

Auditing/Inspection of ECs in India is not something that is very routine.

Answer 1:

Below is the link to ICH-E6-Good Clinical Practice, which would apply for your research studies in India. This guidance does not specially address your question but I've taken some information from the document that might be helpful to you. See below.

www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219488.htm


3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).


3.4 Records The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors, or regulatory authorities to provide copies of its written procedures and membership lists.


4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).


5.1.2 Auditing Procedures The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see section 1.21) to all trial- related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.


5.19.3 Auditing Procedures (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s). (c) The observations and findings of the auditor(s) should be documented. (d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case-by case basis, when evidence of serious GCP noncompliance exists, or in the course of legal proceedings. (e) Where required by applicable law or regulation, the sponsor should provide an audit certificate.


Ultimately, it is the sponsor's responsibility to assure that the study is conducted according to the investigational plan and applicable regulations, (in your case, GCP in India) and that the rights, safety, and welfare of human research subjects are protected. The question in your email is a question you should ask your reviewing Ethics Committee, as each committee has their own rules in this regard

From FDA's IRB regulatory perspective (21 CFR part 56) requires IRBs to maintain certain records, including meeting minutes (21 CFR 56.115(a)(2)), but the regulations only require that the IRB provide access to FDA (21 CFR 56.115(b)). I am not aware of anything in FDA's regulations or written guidance that addresses IRBs providing sponsors with access to their meeting minutes.


The regulations only require, in 21 CFR 56.109(e), that "An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing...." As you noted, FDA's Information Sheet Guidance for Institutional Review Boards and Clinical Investigators "Sponsor - Investigator - IRB Interrelationships" (available at www.fda.gov/RegulatoryInformation/Guidances/ucm126425.htm) indicates that the notification required by 21 CFR 56.109(e) provides "... reasonable assurance that an IRB complies with 21 CFR part 56..."

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