NOTIFICATIONS CORCERNING CLINICAL TRIALS WITH MEDICINAL PRODUCTS / MEDICAL DEVICES


For those clinical trials already authorized by the AEMPS, informative documentation must be sent to the REC taking into account the following aspects:
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FORMAT AND SHIPPING ADDRESS: All notifications must be sent only in digital format via the Clinical Trials with Medicinal Products Portal of the Ministry of Health Consumer Affairs and Social Welfare, except for the reporting of serious breaches to the REC, which will be sent via email to the following address: notificacionsceic.germanstrias@gencat.cat
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ACKNOWLEDGMENT OF RECEIPT: The receipt automatically generated by the Clinical Trials with Medicinal Products Portal of the Ministry of Health, Consumer Affairs and Social Welfare shall be considered as an acknowledgement of receipt.

Here you can find the notifications that the REC MUST RECEIVE and the ones it MUST NOT RECEIVE
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 NOTIFICATIONS CONCERNING CLINICAL TRIALS WITH MEDICINAL PRODUCTS / MEDICAL DEVICES

NOTIFICATIONS CORCERNING RESEARCH PROJECTS / OBSERVATIONAL STUDY WITH MEDICINAL PRODUCT

Once the study has received approval from the REC, all informative documentation must be sent to the REC taking into account the following aspects:
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FORMAT AND SHIPPING ADDRESS: All notifications must be sent only in digital format via email to the following address: notificacionsceic.germanstrias@gencat.cat

ACKNOWLEDGMENT OF RECEIPT: Acknowledgment of receipt of the documentation you send will not be issued. If you need an acknowledgment of recepit, you can enable an email setting called "read receipt"

Here you can find the notifications that the REC MUST RECEIVE and the ones it MUST NOT RECEIVE
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 NOTIFICATIONS CORCERNING RESEARCH PROJECTS / OBSERVATIONAL STUDY WITH MEDICINAL PRODUCT