0A4F4F9BD490A749D5437F821CF06DF1

EU Clinical Trials Register: FAQs

https://www.clinicaltrialsregister.eu/doc/EU_CTR_FAQ.pdf

http://leaux.net/URLS/ConvertAPI Text Files/150764384156A90932F0BCBDF0B74CAB.en.txt

Examining the file media/Synopses/150764384156A90932F0BCBDF0B74CAB.html:

This file was generated: 2020-07-15 06:43:33

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
SocialAccess to Social Goodsaccess1
SocialAccess to informationaccess to information1
SocialMarital Statussingle1
SocialTrade Union Membershipunion5
Socialphilosophical differences/differences of opinionopinion4
General/OtherRelationship to Authorityauthority3

Social / Access to Social Goods

Searching for indicator access:

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p.(None): or the European Economic Area.
p.(None): • The description of any paediatric clinical trial with investigator sites in the European Union.
p.(None): • The description of any paediatric clinical trial that is marketing authorisation holder- sponsored and involves
p.(None): the use in the paediatric population of a medicinal product covered by an EU marketing authorisation (Article 46 of
p.(None): Regulation (EC) No 1901/2006), including those where the investigator sites are outside the European Union.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 2/7
p.(None):
p.(None): • The description of any trials which form part of an agreed paediatric investigation plan (PIP) including those
p.(None): where the investigator sites are outside the European Union.
p.(None): • Summaries of results of the clinical trials mentioned above (if results have been posted by the sponsor or
p.(None): marketing authorisation holder).
p.(None): • Summaries of results (with a reduced set of data fields) of paediatric trials that were completed by 26 January
p.(None): 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation (EC) No 1901/2006)
p.(None): [These trials are presented in a dedicated tab in the user interface.]
p.(None): The EU Clinical Trials Register website does not:
p.(None):
p.(None): • Provide information on non-interventional clinical trials of medicines (observational studies on authorised
p.(None): medicines).
p.(None): • Provide access to the authorisation document from the national medicine regulatory authority or the opinion
p.(None): document from the relevant ethics committee.
p.(None): • Provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures.
p.(None): • Manage the process for joining any clinical trial published on the website.
p.(None):
p.(None): • Provide navigation and web content in languages other than English.
p.(None): *Information on non-interventional post authorisation safety studies can be found on the electronic ENCePP register of
p.(None): studies which provides a publicly accessible resource for the registration of pharmacoepidemiological and
p.(None): pharmacovigilance studies.
p.(None): http://www.encepp.eu/encepp/studiesDatabase.jsp
p.(None):
p.(None): Q.4. What information is available?
p.(None): A. Information on the design of each clinical trial, its sponsor(s), the investigational medicinal product(s) and
p.(None): therapeutic area(s) involved and its trial status (authorised, ongoing, complete, etc.) is available. Users can search
p.(None): all available data using the free text search and the advanced search filters..
p.(None): • Clinical trials in the register are those which have been authorised by the national medicine regulatory
p.(None): authority and have a positive opinion of the ethics committee for clinical trials in the Member State where they have
...

Social / Access to information

Searching for indicator access to information:

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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7 March 2014 EMA/199793/2011
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): Questions and answers relating to practical and technical aspects of the EU Clinical Trials Register
p.(None):
p.(None):
p.(None): IMPORTANT: Refer to the How to Search EU Clinical Trials Register guide (under ‘About here for more information’ on the
p.(None): EU CTR Search page) for detailed guidance on using the search functionality.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
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p.(None):
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p.(None):
p.(None): 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
p.(None): Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20
p.(None): E-mail info@ema.europa.eu Website www.ema.europa.eu
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): An agency of the European Union
p.(None):
p.(None): © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
p.(None):
p.(None):
p.(None): Q.1. What is the EU Clinical Trials Register?
p.(None): A. The EU Clinical Trials Register is part of EudraPharm. EudraPharm is the community database of authorised medicinal
p.(None): products. The website provides public access to information extracted from the EU clinical trials database, EudraCT.
p.(None): The EU Clinical Trials Register contains information on clinical trials with investigator sites in the EEA. Clinical
p.(None): trials where the investigator sites are outside the EEA are only included if they are marketing authorisation
p.(None): holder-sponsored and involve the use in the paediatric population of a medicinal product covered by an EU marketing
p.(None): authorisation (Article 46 of Regulation (EC) No 1901/2006), or if they form part of an agreed PIP (Paediatric
p.(None): Investigation Plan). The register offers users the ability to search for information on any paediatric clinical trial,
p.(None): and any Phase II-IV adult clinical trial recorded in EudraCT.
p.(None): In addition to the above trials, the register also provides summary information about any paediatric trials that were
p.(None): completed by 26 January 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation
p.(None): (EC) No 1901/2006). These trials are presented in a dedicated tab in the user interface.
p.(None):
p.(None): Q.2. Why has the EU Clinical Trials Register been launched?
p.(None): A. The EU Clinical Trials Register website provides the public with information held in the EU clinical trials
p.(None): database, EudraCT. EudraCT is used by national competent authorities to support supervision of clinical trials and was
p.(None): established as a confidential database, in accordance with article 11 of Directive 2001/20/EC. EU pharmaceutical
p.(None): legislation requires the European Medicines Agency (EMA), which maintains the EudraCT database on behalf of EU member
p.(None): states to provide information held in EudraCT to the public. This is described in article 57 of Regulation (EC) No
p.(None): 726/2004 and article 41 of the Paediatric Regulation (EC) No 1901/2006. Together, they established that data on
...

Social / Marital Status

Searching for indicator single:

(return to top)
p.(None): search your browser’s help for information on its particular implementation.
p.(None): The EU Clinical Trials Register provides customised RSS feeds for any search you might make regularly on the website.
p.(None): For example, if you are interested in clinical trials concerning ‘bowel cancer’, you can tailor your search within the
p.(None): EU Clinical Trials Register search page and simply subscribe to the RSS feed for your search by clicking the RSS link:
p.(None): Once subscribed, you will be able to see when your search returns additional results via your RSS reader. (Note that
p.(None): this feature is not available in Internet Explorer 6.)
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 5/7
p.(None):
p.(None): Q.13 When I select United Kingdom with the status 'Ongoing', why do the search results return clinical trials with
p.(None): the status for United Kingdom 'Completed'?A: Such a search returns a list of clinical trials for which the values ‘GB’
p.(None): and ‘Ongoing’ are present. It should be noted that this does not mean that the status 'Ongoing' is necessarily
p.(None): associated with the country ‘GB’, but rather that it is associated with the clinical trial itself which may have
p.(None): multiple trial statuses across all participating countries.
p.(None): Q.14 Why is for example the sum of returned trial records of a search for United Kingdom phase II ongoing trials
p.(None): commenced in 2011 and that of United Kingdom phase II completed trials commenced in 2011 not the same as the sum of
p.(None): returned trial records of United Kingdom phase II ongoing and completed trials commenced in 2011?
p.(None): A: Both trial statuses of ‘Completed’ and ‘Ongoing’ may be present for a single clinical trial, because trials
p.(None): frequently take place in multiple countries. For example, a clinical trial taking place in the United Kingdom and
p.(None): France might, at some point in time, have a trial status of ‘Completed’ in France and ‘Ongoing’ in the United Kingdom.
p.(None): Such clinical trials therefore belong to the intersection between the two sets of search results, since they fulfil
p.(None): search criteria (i.e. UK Phase II ongoing trials commenced in 2011 and UK Phase II completed trials commenced in 2011)
p.(None): as the following Venn diagram illustrates:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 6/7
p.(None):
p.(None): Simply adding up the numbers of set 1 (UK Phase II ‘Ongoing’ 2011 (313)) and set 2 (UK Phase II ‘Completed’ 2011 (48))
p.(None): would result in double counting 30 clinical trials in the intersection, so these must be subtracted to reach an
p.(None): accurate total.
p.(None): Q.15 What should I do if my question is not answered here?
p.(None): A: If your question regarding the EU Clinical Trials Register is not answered here, or in the How to Search EU Clinical
p.(None): Trials Register guide, please send your question to euctr@ema.europa.eu.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...

Social / Trade Union Membership

Searching for indicator union:

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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7 March 2014 EMA/199793/2011
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): Questions and answers relating to practical and technical aspects of the EU Clinical Trials Register
p.(None):
p.(None):
p.(None): IMPORTANT: Refer to the How to Search EU Clinical Trials Register guide (under ‘About here for more information’ on the
p.(None): EU CTR Search page) for detailed guidance on using the search functionality.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
p.(None): Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20
p.(None): E-mail info@ema.europa.eu Website www.ema.europa.eu
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): An agency of the European Union
p.(None):
p.(None): © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
p.(None):
p.(None):
p.(None): Q.1. What is the EU Clinical Trials Register?
p.(None): A. The EU Clinical Trials Register is part of EudraPharm. EudraPharm is the community database of authorised medicinal
p.(None): products. The website provides public access to information extracted from the EU clinical trials database, EudraCT.
p.(None): The EU Clinical Trials Register contains information on clinical trials with investigator sites in the EEA. Clinical
p.(None): trials where the investigator sites are outside the EEA are only included if they are marketing authorisation
p.(None): holder-sponsored and involve the use in the paediatric population of a medicinal product covered by an EU marketing
p.(None): authorisation (Article 46 of Regulation (EC) No 1901/2006), or if they form part of an agreed PIP (Paediatric
p.(None): Investigation Plan). The register offers users the ability to search for information on any paediatric clinical trial,
p.(None): and any Phase II-IV adult clinical trial recorded in EudraCT.
p.(None): In addition to the above trials, the register also provides summary information about any paediatric trials that were
p.(None): completed by 26 January 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation
p.(None): (EC) No 1901/2006). These trials are presented in a dedicated tab in the user interface.
p.(None):
p.(None): Q.2. Why has the EU Clinical Trials Register been launched?
p.(None): A. The EU Clinical Trials Register website provides the public with information held in the EU clinical trials
p.(None): database, EudraCT. EudraCT is used by national competent authorities to support supervision of clinical trials and was
p.(None): established as a confidential database, in accordance with article 11 of Directive 2001/20/EC. EU pharmaceutical
p.(None): legislation requires the European Medicines Agency (EMA), which maintains the EudraCT database on behalf of EU member
p.(None): states to provide information held in EudraCT to the public. This is described in article 57 of Regulation (EC) No
p.(None): 726/2004 and article 41 of the Paediatric Regulation (EC) No 1901/2006. Together, they established that data on
p.(None): clinical trials conducted in adults and in paediatric populations be made public. The EU Clinical Trials Register
p.(None): website puts these requirements into practice.
p.(None): Q.3. What information can I find in the EU Clinical Trials Register?
p.(None): A. The EU Clinical Trials Register website has:
p.(None):
p.(None): • The description of any phase II-IV adult clinical trial where the investigator sites are in the European Union
p.(None): or the European Economic Area.
p.(None): • The description of any paediatric clinical trial with investigator sites in the European Union.
p.(None): • The description of any paediatric clinical trial that is marketing authorisation holder- sponsored and involves
p.(None): the use in the paediatric population of a medicinal product covered by an EU marketing authorisation (Article 46 of
p.(None): Regulation (EC) No 1901/2006), including those where the investigator sites are outside the European Union.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 2/7
p.(None):
p.(None): • The description of any trials which form part of an agreed paediatric investigation plan (PIP) including those
p.(None): where the investigator sites are outside the European Union.
p.(None): • Summaries of results of the clinical trials mentioned above (if results have been posted by the sponsor or
p.(None): marketing authorisation holder).
p.(None): • Summaries of results (with a reduced set of data fields) of paediatric trials that were completed by 26 January
p.(None): 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation (EC) No 1901/2006)
p.(None): [These trials are presented in a dedicated tab in the user interface.]
p.(None): The EU Clinical Trials Register website does not:
p.(None):
p.(None): • Provide information on non-interventional clinical trials of medicines (observational studies on authorised
p.(None): medicines).
p.(None): • Provide access to the authorisation document from the national medicine regulatory authority or the opinion
p.(None): document from the relevant ethics committee.
p.(None): • Provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures.
p.(None): • Manage the process for joining any clinical trial published on the website.
p.(None):
p.(None): • Provide navigation and web content in languages other than English.
p.(None): *Information on non-interventional post authorisation safety studies can be found on the electronic ENCePP register of
p.(None): studies which provides a publicly accessible resource for the registration of pharmacoepidemiological and
p.(None): pharmacovigilance studies.
p.(None): http://www.encepp.eu/encepp/studiesDatabase.jsp
p.(None):
p.(None): Q.4. What information is available?
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

(return to top)
p.(None): • The description of any paediatric clinical trial that is marketing authorisation holder- sponsored and involves
p.(None): the use in the paediatric population of a medicinal product covered by an EU marketing authorisation (Article 46 of
p.(None): Regulation (EC) No 1901/2006), including those where the investigator sites are outside the European Union.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 2/7
p.(None):
p.(None): • The description of any trials which form part of an agreed paediatric investigation plan (PIP) including those
p.(None): where the investigator sites are outside the European Union.
p.(None): • Summaries of results of the clinical trials mentioned above (if results have been posted by the sponsor or
p.(None): marketing authorisation holder).
p.(None): • Summaries of results (with a reduced set of data fields) of paediatric trials that were completed by 26 January
p.(None): 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation (EC) No 1901/2006)
p.(None): [These trials are presented in a dedicated tab in the user interface.]
p.(None): The EU Clinical Trials Register website does not:
p.(None):
p.(None): • Provide information on non-interventional clinical trials of medicines (observational studies on authorised
p.(None): medicines).
p.(None): • Provide access to the authorisation document from the national medicine regulatory authority or the opinion
p.(None): document from the relevant ethics committee.
p.(None): • Provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures.
p.(None): • Manage the process for joining any clinical trial published on the website.
p.(None):
p.(None): • Provide navigation and web content in languages other than English.
p.(None): *Information on non-interventional post authorisation safety studies can be found on the electronic ENCePP register of
p.(None): studies which provides a publicly accessible resource for the registration of pharmacoepidemiological and
p.(None): pharmacovigilance studies.
p.(None): http://www.encepp.eu/encepp/studiesDatabase.jsp
p.(None):
p.(None): Q.4. What information is available?
p.(None): A. Information on the design of each clinical trial, its sponsor(s), the investigational medicinal product(s) and
p.(None): therapeutic area(s) involved and its trial status (authorised, ongoing, complete, etc.) is available. Users can search
p.(None): all available data using the free text search and the advanced search filters..
p.(None): • Clinical trials in the register are those which have been authorised by the national medicine regulatory
p.(None): authority and have a positive opinion of the ethics committee for clinical trials in the Member State where they have
p.(None): been run. Additionally, clinical trials including the paediatric population that have received a negative ethics
p.(None): committee opinion are also made public.
p.(None): • Phase 1 clinical trials in adults are not being made public unless they form part of an agreed Paediatric
p.(None): Investigation Plan (PIP). These criteria are those established by the guidelines published by the European Commission.
p.(None): Q.5. How do I find the EU Clinical Trials Register?
p.(None): A. The EU Clinical Trials Register is part of EudraPharm and can be accessed from the EudraPharm homepage
p.(None): The homepage of the EU Clinical Trial Register is: http://www.clinicaltrialsregister.eu
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 3/7
p.(None):
p.(None): Q.6. Who provides the information?
p.(None): A. Protocol information on any clinical trial conducted in the EU Member States is provided, in electronic format, to
p.(None): the national medicine regulatory authorities by the trial sponsor as part of the sponsor’s application for
p.(None): authorisation to conduct a trial. It is entered into the database by the national competent authority which adds the
p.(None): authorisation, the ethics committee opinion, and later completes the end-of-trial information.
p.(None): The information on third-country clinical trials is supplied by the third country data providers (i.e.
p.(None): Paediatric-Investigation-Plan (PIP) addressees or Article 46 data providers) who enter the information directly to the
p.(None): system.
p.(None): Result related information is entered by sponsors, marketing authorisation holders and PIP addressees directly to the
p.(None): system.
p.(None): Q.7 Data displayed for some clinical trials is incomplete. How will data quality improve?
p.(None): A. National competent authorities and the Agency are working to develop, where possible, a more complete data set for
p.(None): historical trials (May 2004-March 2011) entered in the EudraCT database. Furthermore, it aims to improve the quality of
p.(None): the new records through enhanced automated checking, quality control and through the increased use of standardised
p.(None): data.
p.(None): Data quality and historical information:
p.(None):
p.(None): Information on clinical trials entered into the database between May 2004 and March 2011 is referred to as historical
p.(None): data. It may be incomplete or contain inconsistencies. For instance, the end date of a trial may not have been entered,
p.(None): so the trial may appear to have a trial status of ‘Ongoing’ when in fact it has been completed. Member states
p.(None): implemented the Directive and started using EudraCT at different times between 2004 and 2006 and the links with the
p.(None): ethics committees needed to be established. The validation rules applying to the data have been upgraded and the EMA is
p.(None): working with national competent authorities to ensure key data on the status of existing trials is complete
p.(None): Q.8 Where can I get more information about a specific trial?
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): • The description of any paediatric clinical trial with investigator sites in the European Union.
p.(None): • The description of any paediatric clinical trial that is marketing authorisation holder- sponsored and involves
p.(None): the use in the paediatric population of a medicinal product covered by an EU marketing authorisation (Article 46 of
p.(None): Regulation (EC) No 1901/2006), including those where the investigator sites are outside the European Union.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 2/7
p.(None):
p.(None): • The description of any trials which form part of an agreed paediatric investigation plan (PIP) including those
p.(None): where the investigator sites are outside the European Union.
p.(None): • Summaries of results of the clinical trials mentioned above (if results have been posted by the sponsor or
p.(None): marketing authorisation holder).
p.(None): • Summaries of results (with a reduced set of data fields) of paediatric trials that were completed by 26 January
p.(None): 2007 in respect of products covered by an EU marketing authorisation (Article 45 of Regulation (EC) No 1901/2006)
p.(None): [These trials are presented in a dedicated tab in the user interface.]
p.(None): The EU Clinical Trials Register website does not:
p.(None):
p.(None): • Provide information on non-interventional clinical trials of medicines (observational studies on authorised
p.(None): medicines).
p.(None): • Provide access to the authorisation document from the national medicine regulatory authority or the opinion
p.(None): document from the relevant ethics committee.
p.(None): • Provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures.
p.(None): • Manage the process for joining any clinical trial published on the website.
p.(None):
p.(None): • Provide navigation and web content in languages other than English.
p.(None): *Information on non-interventional post authorisation safety studies can be found on the electronic ENCePP register of
p.(None): studies which provides a publicly accessible resource for the registration of pharmacoepidemiological and
p.(None): pharmacovigilance studies.
p.(None): http://www.encepp.eu/encepp/studiesDatabase.jsp
p.(None):
p.(None): Q.4. What information is available?
p.(None): A. Information on the design of each clinical trial, its sponsor(s), the investigational medicinal product(s) and
p.(None): therapeutic area(s) involved and its trial status (authorised, ongoing, complete, etc.) is available. Users can search
p.(None): all available data using the free text search and the advanced search filters..
p.(None): • Clinical trials in the register are those which have been authorised by the national medicine regulatory
p.(None): authority and have a positive opinion of the ethics committee for clinical trials in the Member State where they have
p.(None): been run. Additionally, clinical trials including the paediatric population that have received a negative ethics
p.(None): committee opinion are also made public.
p.(None): • Phase 1 clinical trials in adults are not being made public unless they form part of an agreed Paediatric
p.(None): Investigation Plan (PIP). These criteria are those established by the guidelines published by the European Commission.
p.(None): Q.5. How do I find the EU Clinical Trials Register?
p.(None): A. The EU Clinical Trials Register is part of EudraPharm and can be accessed from the EudraPharm homepage
p.(None): The homepage of the EU Clinical Trial Register is: http://www.clinicaltrialsregister.eu
p.(None):
p.(None):
p.(None):
p.(None): EU Clinical Trials Register – FAQs
p.(None): EMA/199793/2011
p.(None): Page 3/7
p.(None):
p.(None): Q.6. Who provides the information?
p.(None): A. Protocol information on any clinical trial conducted in the EU Member States is provided, in electronic format, to
p.(None): the national medicine regulatory authorities by the trial sponsor as part of the sponsor’s application for
p.(None): authorisation to conduct a trial. It is entered into the database by the national competent authority which adds the
p.(None): authorisation, the ethics committee opinion, and later completes the end-of-trial information.
p.(None): The information on third-country clinical trials is supplied by the third country data providers (i.e.
p.(None): Paediatric-Investigation-Plan (PIP) addressees or Article 46 data providers) who enter the information directly to the
p.(None): system.
p.(None): Result related information is entered by sponsors, marketing authorisation holders and PIP addressees directly to the
p.(None): system.
p.(None): Q.7 Data displayed for some clinical trials is incomplete. How will data quality improve?
p.(None): A. National competent authorities and the Agency are working to develop, where possible, a more complete data set for
p.(None): historical trials (May 2004-March 2011) entered in the EudraCT database. Furthermore, it aims to improve the quality of
p.(None): the new records through enhanced automated checking, quality control and through the increased use of standardised
p.(None): data.
p.(None): Data quality and historical information:
p.(None):
p.(None): Information on clinical trials entered into the database between May 2004 and March 2011 is referred to as historical
p.(None): data. It may be incomplete or contain inconsistencies. For instance, the end date of a trial may not have been entered,
p.(None): so the trial may appear to have a trial status of ‘Ongoing’ when in fact it has been completed. Member states
p.(None): implemented the Directive and started using EudraCT at different times between 2004 and 2006 and the links with the
p.(None): ethics committees needed to be established. The validation rules applying to the data have been upgraded and the EMA is
...


Orphaned Trigger Words



Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
access to informationAccess to information
authorityRelationship to Authority
opinionphilosophical differences/differences of opinion
singleMarital Status
unionTrade Union Membership

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

ethics


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
SocialAccess to Social Goodsaccess1
SocialAccess to informationaccess to information1
SocialMarital Statussingle1
SocialTrade Union Membershipunion5
Socialphilosophical differences/differences of opinionopinion4
General/OtherRelationship to Authorityauthority3