The following procedures are related to changes to be assessed by the CCMO Central Committee on Research involving Human Subjects (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 (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: