The following procedures are related to changes to be assessed by the CCMOCentral 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 VWSMinistry 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:
A cover letter, including the reasons for the amendment in one or two sentences, a brief description of the changes that are included in the amendment, the names of the documents that are modified, and the reason for qualifying these changes as substantial.
The EudraCTEuropean Union Drug Regulating Authorities Clinical Trials Substantial Amendment Notification form (see the CCMOCentral Committee on Research involving Human Subjects website, ‘Changes in research file’).
The modified documents (or extracts), showing both the previous and new wording (version with track changes).
The new version of the modified documents, identified with updated number of version and date.
If applicable, the following data in support of the application can also be included:
- summaries of results or data already collected;
- an updated risk-benefit analysis;
- possible consequences for subjects already included in the study;
- possible consequences for the outcome of the study.
The legal deadline for assessing amendments to gene therapy research is 35 days.