Reporting requirements
Legal background:
Decree 35/2005 (VIII. 26) of the Minister of Health on the conduct of clinical trials on investigational medicinal products for human use and the implementation of Good Clinical Practice reviewed on 21-10-2009
Clinical Reports (for all Investigational Medicinal Products)
|
Source |
Reportable |
Timeline |
|
Suspected Unexpected Serious AR (SUSAR) |
||
|
Domestic |
YES |
7*/15 days |
|
EEA |
NO |
NA |
|
Non-EEA |
NO |
NA |
|
Suspected Expected Serious AR |
||
|
Domestic |
NO |
NA |
|
EEA |
NO |
NA |
|
Non-EEA |
NO |
NA |
|
Suspected Unexpected Non-serious AR |
||
|
Domestic |
NO |
NA |
|
EEA |
NO |
NA |
|
Non-EEA |
NO |
NA |
|
Non-suspected Adverse Event (AE) |
||
|
Domestic |
NO |
NA |
|
EEA |
NO |
NA |
|
Non-EEA |
NO |
NA |
Please note:
Other clinical safety information:
Safety Notification Letters if generated should be sent to NIP immediately but at latest 24 hours. This type of letter should be submitted if the new events affect the conduct of the trial or the safety of the subjects considerably (such as lack of efficacy of an investigational medicinal product used for the treatment of a life-threatening disease, a major safety finding from a newly completed animal study (such as carcinogenicity), any anticipated end or temporal halt of a trial for safety reasons conducted with the same investigational medicinal product in another country by the same sponsor.
SUSAR Line listings should be submitted within 60 days after data lock point. CD format is required. Subject Identification ID in the cover letter is 4105. Line Listings must be addressed to the Clinical Trials Unit.
Annual Safety Reports (ASRs) and Development Update Safety Reports (DSURs) should be submitted within 60 days after data lock point. CD format is required. The subject identification ID for the submissions is 4105. ASRs and DSURs must be addressed to the Clinical Trials Unit.
Please send documents addressed to the central Ethics Committee (cEC) directly to cEC.
