ICH E6(R3) - Good Clinical Practice
Annex 1 section 3: sponsor – ICH E6(R3) - Good Clinical Practice

ICH E6(R3) - Good Clinical Practice 3.17: On termination or suspension inform investigators, regulators and the IRB/IEC promptly with reasons and give follow-up information; prepare clinical trial reports to ICH E3; and after unblinding make results public, tell investigators about treatments and results and give participants plain-language summaries

What does 3.17 require?

If a trial is stopped early or suspended, the sponsor should quickly tell investigators, institutions and regulators, with reasons; the IRB/IEC should also be told promptly with reasons by the sponsor or investigator as regulation requires; and the sponsor should give investigators information on subsequent therapy and follow-up where appropriate. Whether completed, terminated or analysed at an interim point for submission, clinical trial reports, including interim reports, should be prepared and provided to regulators as required, meeting ICH E3 in marketing applications (abbreviated reports may sometimes be acceptable), with a coordinating investigator considered as signatory. Once unblinded and analysed, the sponsor should generally make results public, tell investigators which treatment their participants received in blinded trials and give them the results, and any participant summary should be non-technical, understandable to lay readers and non-promotional.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

Other controls in Annex 1 section 3: sponsor – ICH E6(R3) - Good Clinical Practice

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