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Clinical trials with a medicinal product fall under the Research Involving Human Subjects Act (WMO) and must first be approved by an accredited medical research ethics committee (MREC or Central Committee on Research involving Human Subjects CCMO (CCMO)) and a competent authority (CCMO or Ministry of Health, Welfare and Sport) for approval. The MEB is not the competent authority in the field of clinical trial authorisation.
Suspected Unexpected Serious Adverse Reactions (SUSARs) during a clinical trial with a medicinal product must be reported to the competent authority (CCMO or Ministry of Health, Welfare and Sport), a review committee (MREC or CCMO) and the MEB. The disclosure obligation to the MEB has been met once the SUSAR has been sent to the EudraVigilance Clinical Trial Module (EVTCM).
As some sponsors of clinical trials with medicinal products have indicated that they wish to receive a formal, written confirmation of this approach, you can submit a request for exemption from the reporting obligation to the MEB.
Please use the following text in a letter and subsequently upload the letter using this form. The text should be printed on paper with company logo, be amended where necessary, and signed.
"I hereby declare that all cases meeting the definition of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports as defined in clinical trial legislation are submitted to the EMA EudraVigilance database in E2B format within the appropriate time frames (7/15 days).
Our procedures are compliant with the Clinical Trials Directive 2001/20/EC and associated EU Commission guidance “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (ref 2011/C 172/01)
We would like to request for a waiver to report SUSARs directly to the MEB.
In case of technical problems with E2B SUSAR reporting to the EMA, SUSAR reports will be sent to the EMA in an alternative way in line with the instructions given by the EMA."
Please note:
- Please specify if this declaration is applicable to all clinical trials that fall under the responsibility of the sponsor or if this request is only applicable to a specific trial. If applicable, specify Study Name, EudraCT number and sponsor protocol number.
- Please specify any relevant exemptions to the above, such as for a specific product, reporting source, country, 3rd party provisions.
- Please be informed that SUSARs should still be reported to the assessing review committee (accredited MREC or CCMO). Visit the page CCMO: SAE's/SUSARs for more information.
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