ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

(b) The sponsor should inform the investigator(s)/institution(s) and service providers, when appropriate, in writing of the requirements for the retention of essential records and should notify the investigator(s)/institution(s) and service providers, when appropriate, in writing when the trial-related records are no longer needed in accordance with applicable regulatory requirements. (c) The sponsor should report to the appropriate authority(ies) any transfer of ownership of the essential records as required by the applicable regulatory requirement(s). The sponsor should also inform the investigator if sponsorship of the trial changes. (a) The sponsor should ensure that it is specified in the protocol or other documented agreement that the investigator(s)/institution(s) provide direct access to source records for trial-related monitoring, audits, regulatory inspection and, in accordance with applicable regulatory requirements, IRB/IEC review. (b) The sponsor should ensure that trial participants have consented to direct access to source records for the purposes outlined in 3.16.4(a) (see section 2.8.10(n)). If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided with the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, in accordance with applicable regulatory requirement(s). Where appropriate, the sponsor should provide the investigator with information about potential subsequent therapy(ies) and follow up for the participants. (a) Whether the trial is completed or prematurely terminated, or an interim analysis is undertaken for regulatory submission, the sponsor should ensure that the clinical trial reports, including interim reports, are prepared and provided to the regulatory authority(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of ICH E3 or are otherwise in accordance with applicable regulatory requirements. (Note: ICH E3 specifies that abbreviated trial reports may be acceptable in certain cases.) Clinical Trial/Study Reports Record Access Reports Premature Termination or Suspension of a Trial

3.16.4

3.17

3.17.1

3.17.2

(b) Where a coordinating investigator is involved in a trial, consideration should be given to them being a signatory on the clinical trial report (see ICH E3).

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