新建假设
EU/EEA EudraCT trials that are expected to continue after30 January 2025 are required totransition those trials to the CTISat their earliest convenience.It's important to be aware that the timeframe for the Member State(s)procedure,which can take up to 3months,is part of the provided deadline.To know how to transition your trial,seeCTIS:how to get started and how to transition a trial。
10-04-2024
Due to essential maintenance of SPOR,the EudraCT website will experience issues between11th of April at6pm(CET)and 15th of April at6pm(CET)。During this timeframe,it will not be possible forusers to upload CTA XML files to perform amendments to trial protocols.Users may also experience service losses in other parts of the website(e.g.results section)。We apologise in advance for any inconvenience caused。
30-01-2024
As of 31 January 2025,all EU/EEA trials need to be conducted under联盟536/2014.Any EU/EEA trial with a foreseen last patient last visit after this date is required to be transitioned to theClinical Trials Information System可焊:变形here,here。
A new version of theFrequently asked questionsis now available.Sponsors are encouraged to refer to it for questions on EudraCT/EUCTR,before submitting a query through our Service Now。
07-12-2023
A new version of theEudraCT results training environmentis now live.This version can be accessed by users who already have access to the EudraCT results application.However,a pre-registration for the training environment is still necessary:full instructions on how to access can be foundhere,here。Please note that the old training environment credentials do not work in this new version,therefore it is not possible forusers to retrieve old mock trials assigned in the old training environment。
1-08-2023
The option of posting a'summary attachment'in the EudraCT results section is allowed in case:the trial never started,the trial terminated early,it is not possible to post a'full data set'or in case the trial has transitioned to CTIS.Thequestions appearing after the sponsor clicks on'post results'have nowberding。
31-05-2023
Due to essential maintenance,EudraCT and EUCTR websites will be briefly unavailable on1st June,between6-7PM CEST.We apologize for this inconvenience and we thank you very much for your patience。
28-03-2023
“Become a results user”functionality is not working as expected and as described in the可回收instructions。更新24Apr2023:this issue is now solved。
Due to essential maintenance,a planned downtime is foreseen for the EudraCT and EUCTR websites on Saturday,April1st,between 8am and 6pm CET.We apologize for this inconvenience and we thank you very much for your patience。
23-02-2023
The EudraCT website has been affected by unexpected SPOR downtimes,which prevent users from performing usual functionalities,such as the uploading of an XML file。更新24 Feb2023:this issue is now solved;however,afewusers have reported that they do not see their trials listed in'your page',inorder to post results.We encourage users to出口this单击功能区上,in case they are affected,to allow a better investigation and resolution by our IT。
In addition,the EudraCT results training environment is currently not accessible:we will keepusers updated on its accessibility through the present webpage。
10-02-2023
Users have reported issues with filling in section H of the EU/EEA CTA for protocol amendments and with the generation of EudraCT numbers for third country files.Our IT is currently working on this,we thank you very much for your patience。更新14 Feb2023:this issue is now solved。
06-02-2023
After implementing a system upgrade,on02-02-2023the EudraCT database experienced issues with results functionalities,which are now solved.We apologise for any inconvenience caused and we thank you for your patience。
31-01-2023
The Clinical Trial Regulation is now mandatory forall initial EU/EEA clinical trial applications.The EudraCT website has been amended accordingly。
15-12-2022
The EMA will be closed for public holidays until03/01/2023 included.All requests submitted to the EudraCT team after21/12/2022 will be processed from04/01/2023.This includes服务Now queries,emails toEudraCT_notification@ema.europa.eu and requests for assignments to trials for the purpose of posting results.We thank you for your understanding and we encourage you to refer to theFrequently Asked Questionsin the meantime。
07-12-2022
EudraCT and EUCTR experienced several unexpected downtimes recently.Both websites are now operational and users can access them.We apologise for any inconvenience caused and we thank you for your patience。
02-12-2022
Due to essential maintenance,the EudraCT website will have a downtime this evening between6pm and 8pm(CET)。We apologise for this inconvenience and we thank you very much for your patience。
22-11-2022
Sponsors of clinical trials on COVID-19are reminded to include the term“COVID-19”in the title of their trial(section A.3of the CTA).Sponsors are also reminded of the importance of timely reporting of SAEs(Serious Adverse Events)and of SUSARs,in order to protect the safety of the participants.In addition,we encourage sponsors of COVID-19trials to地点,地点the relevant results as soon as it is feasible,also before the deadline。
14-11-2022
Users have reported issues with uploading CTA XML files on EudraCT.Our IT is currently working on this,we thank you very much for your understanding and patience。更新21 Nov2022:this issue is now solved。
26-09-2022
Kindly Note that the EMA Service Desk has changed to Service Now and can be accessed viahttps://support.ema.europa.eu/esc.If you cannot access through this portal,please report your issue or ask your question through using the email addressEudraCT_notification@ema.europa.eu。 We thank you very much for your collaboration。
31-08-2022
Due to essential maintenance of SPOR,the EudraCT website may experience momentary service losses on3and4September 2022.We apologise for this inconvenience and we thank you very much for your patience。
29-07-2022
A considerable amount of clinical trials are currently marked as“ongoing”in the EudraCT database.In view of the upcomingtransition of trials to CTIS单击功能区上,sponsors are encouraged to verify wherer the correct status of their trials is reported on欧盟CTR.An端部纵向变形needs to be submitted to National Competent Authorities for the trials that should be marked as“completed”or“prematurely ended”。内部,sponsors are requested to post results of these trials as per European Commissionguideline2012/C302/03:to know how to post results visit汽化炉炉膛温度.For questions,refer toContact us。
30-06-2022
Following the issuing of theJoint Letter by the European Commission,EMA and HMA单击功能区上,National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with theEuropean Commission guidelineon results posting.Thanks to these reminders,the percentage of posted results substantially increased.However,for some trials the reminders were not successful:detailed lists of these trials can be foundhere,here。
03-03-2022
Following the European Commission'sGuidance on results postings单击功能区上,European Medicines Agency and National Competent Authorities sent rounds of notifications inorder to remind sponsors of their responsibilities as regards posting clinical trial results in EudraCT.In attempt to reach sponsors who have not uploaded results yet,在欧洲CT,but also in other databases,such as the EMA Eudra Common Directory,EudraVigilance,SPOR and Art.57database。
The EMA recommends all sponsors to verify if their trials comply with theGuidance on results postings前围桥名in欧盟CTR.To learn how to post results visit汽化炉炉膛温度。
预应力钢筋here,here
For the UK,as of 1.1.2021,EU Law applies only to the territory of Northern Ireland(NI)to the extent foreseen in the Protocol on Ireland/Ni。
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