The following procedures are related to changes to be assessed by the CCMO (Central Committee on Research involving Human Subjects ).
Substantial changes will have to be re-examined before they can be implemented and must be submitted to the committee for assessment. For more informational check the guidance document 'Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial'.
Non-substantial amendments should be recorded and filed by the sponsor and should be available on request for inspection at the trial site and/or the sponsor's premises as appropriate.
It is the sponsor who determines whether or not an amendment is substantial in nature. A substantial amendment must be submitted to the CCMO for assessment. The Minister of VWS (Ministry of Health, Welfare and Sport
) (Health, Welfare and Sport) must also be notified of the amendment. The amendment must not be implemented before the investigator has received a positive decision from the CCMO and a declaration of no objection from the Minister of VWS.
The request for assessment of an amendment must be accompanied by the following documentation: