Several notifications and reports must be submitted to the CCMO Central Committee on Research involving Human Subjects (Central Committee on Research involving Human Subjects ) and VWS Ministry of Health, Welfare and Sport (Ministry of Health, Welfare and Sport ) through the Gene Therapy Office.
Notification of start date to CCMO
You must inform the CCMO of the definitive start date of the study in the Netherlands. The start date is the date of inclusion of the first research subject. The start of a study must occur within a year of issue of the positive decision. The decision expires after that year.
Progress report to CCMO
The CCMO must be sent annual progress reports on all the research that it has assessed. A requirement to this effect is included in the text of its own assessments. In the case of gene therapy research, you are obliged to submit a progress report every year. For this purpose you have to fill in the progress report form (formulier voortgangsrapportage), which can be downloaded from the CCMO website.
If the CCMO deems it necessary, a more extensive report will then be requested. This report will cover such matters as:
- The number of patients included in the study
- The number of patients withdrawn from the study
- All suspected serious adverse drug reactions that have occurred that year, plus a report on the safety of the research subjects.
The CCMO and the competent authority (VWS) must be sent an annual safety report regarding the investigational medicinal product. This report consists of:
- A list of all suspected serious adverse drug reactions (both expected and unexpected) in the form of a table listing all reported serious adverse drug reactions classified per organ system for each study
- A report about the safety of the research subjects. This report contains a full safety analysis and an evaluation of the balance between the efficacy and harmful effects of the investigational medicinal product.
If so desired, the safety report can also be combined with the progress report.
Notification of end of study
You must inform the CCMO within 90 days about the end date of a study in the Netherlands. The end date of a study is the date on which the last measurement is carried out for the last research subject. A report must be sent by means of the form ‘CCMO form end of trial’, which can be downloaded from the CCMO website. If the study ends prematurely then this must be sent within 15 days. The EudraCT European Union Drug Regulating Authorities Clinical Trials (European Union Drug Regulating Authorities Clinical Trials ) form entitled ‘Declaration of the End of Trial Form’ must also be sent to both the CCMO and Ministry of VWS. The form can be downloaded from the EudraLex website.
Within a year of completion of the research (whether premature or not) you must send a summary of the results to the CCMO and VWS.