0A4F4F9BD490A749D5437F821CF06DF1
EudraLex Volume 10: Clinical Trials
https://ec.europa.eu/health/documents/eudralex/vol-10/
http://leaux.net/URLS/ConvertAPI Text Files/1EBE691376144FBCBE19BDD5B6CC10D4.en.txt
Examining the file media/Synopses/1EBE691376144FBCBE19BDD5B6CC10D4.html:
This file was generated: 2020-07-15 06:39:47
| 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
Social / Child
Searching for indicator children:
(return to top)
p.(None): Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for
p.(None): human use (OJ L 262, 14.10.2003, p. 22-26)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): e-newsletter Thu, 03/05/2020
p.(None):
p.(None):
p.(None): Put the horse before the cart: Investing in health requires investing in health workforce
p.(None):
p.(None):
p.(None):
p.(None): Latest updates
p.(None):
p.(None): Agenda - 86th meeting of the Pharmaceutical Committee (12 March 2020) •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Questions and answers (version 17) - Safety features for medicinal products for human use •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Documents - 85th meeting of the Pharmaceutical Committee (17 December 2019)
p.(None): Released 18 December 2019
p.(None):
p.(None):
p.(None):
p.(None): Follow us on More
p.(None): twitter
p.(None):
p.(None):
p.(None):
p.(None): Highlights
p.(None):
p.(None): Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Conference “Medicines for rare diseases and children: learning from the past, looking to the future” (Brussels, 17 June 2019)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notice to stakeholders - Withdrawal of the United Kingdom and EU rules in the field of clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the
p.(None): framework of the Centralised Procedure
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notice to marketing authorisation holders of centrally authorised medicinal products concerning the United Kingdom's notification pursuant to Article 50 of the Treaty on
p.(None): European Union
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Related information
p.(None):
p.(None): Press material Videos
p.(None):
p.(None):
p.(None):
p.(None): Eurobarometers Events
p.(None):
p.(None):
p.(None):
p.(None): Consultations Publications
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public Health
p.(None):
p.(None): European Commission
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.(None): Cookies
p.(None): This site uses cookies to offer you a better browsing experience. Find out more on how we use cookies and how you can change your
p.(None): settings.
p.(None):
p.(None):
p.(None): I accept cookies I refuse cookies
p.(None):
p.(None):
p.(None): An official EU website
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): English
p.(None): EN
p.(None):
p.(None):
p.(None): Home Live, work, travel in the EU Public Health Medicinal products
p.(None):
p.(None):
p.(None): Medicinal products
p.(None):
p.(None):
p.(None): All topics ►
p.(None):
p.(None):
p.(None): Medicinal products
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EudraLex - Volume 10 - Clinical trials guidelines
p.(None): Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.
p.(None):
p.(None): A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover
p.(None): new aspects introduced by the same Regulation.
p.(None):
p.(None): In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under
p.(None): Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website.
p.(None):
p.(None): Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.
p.(None):
p.(None): During the transitional period, which will last for a period of 3 years starting from when the Regulation becomes applicable, both sets of documents will apply accordingly and should be referred to respectively according to
p.(None): the legislation under which the Clinical trial is conducted.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): Cookies
p.(None): This site uses cookies to offer you a better browsing experience. Find out more on how we use cookies and how you can change your
p.(None): settings.
p.(None):
p.(None):
p.(None): I accept cookies I refuse cookies
p.(None):
p.(None):
p.(None): An official EU website
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): English
p.(None): EN
p.(None):
p.(None):
p.(None): Home Live, work, travel in the EU Public Health Medicinal products
p.(None):
p.(None):
p.(None): Medicinal products
p.(None):
p.(None):
p.(None): All topics ►
p.(None):
p.(None):
p.(None): Medicinal products
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EudraLex - Volume 10 - Clinical trials guidelines
p.(None): Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.
p.(None):
p.(None): A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover
p.(None): new aspects introduced by the same Regulation.
p.(None):
p.(None): In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under
p.(None): Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website.
p.(None):
p.(None): Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.
p.(None):
p.(None): During the transitional period, which will last for a period of 3 years starting from when the Regulation becomes applicable, both sets of documents will apply accordingly and should be referred to respectively according to
p.(None): the legislation under which the Clinical trial is conducted.
p.(None):
p.(None): At the end of the transitional period all clinical trials shall be conducted under the Regulation and should follow only the set of documents applicable to the Regulation.
p.(None):
p.(None): Although it is not mandatory, stakeholders are encouraged to take already into consideration a number of aspects that are outlined in the new or updated documents published in the page dedicated to the Clinical Trial
p.(None): Regulation and apply them to those clinical trials authorised under the Directive, to the extent possible and in compatibility with the legal framework of the Directive.
p.(None):
p.(None): Browse the theme
p.(None):
p.(None):
p.(None):
...
p.(None): 2006)
p.(None): Detailed guidance on the European clinical trials database (EUDRACT Database) ••• (revision of April 2004)
p.(None):
p.(None): Chapter II - Safety reporting
p.(None): 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")
p.(None): ICH guideline E2F - Note for guidance on development safety update reports (September 2010)
p.(None):
p.(None): Chapter III - Quality of the investigational medicinal product
p.(None): Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries :PDF version - Word version (may 2013)
p.(None): Good manufacturing practice for investigational medicinal products
p.(None): Good manufacturing practices for manufacture of investigational medicinal products (February 2010)
p.(None): Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No
p.(None): 536/2014 (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
p.(None): Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
p.(None): Union Basic Format for Manufacturer's Authorisation (June 2013)
p.(None): Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials •••
p.(None):
p.(None):
p.(None): Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (May 2012)
p.(None): Guidance on Investigational Medicinal Products (IMPs) and "non investigational medicinal products" (NIMPs) (rev. 1, March 2011)
p.(None):
p.(None): Chapter IV - Inspections
p.(None): Guidance for the preparation of GCP inspections ••• (June 2008)
p.(None): Recommendation on inspection procedures for the verification of good clinical practice compliance ••• (July 2006)
p.(None): Guidance for the conduct of GCP inspections ••• (June 2008)
p.(None): Annex I to Guidance for the conduct of GCP inspections - Investigator site ••• (June 2008)
p.(None): Annex II to Guidance for the conduct of GCP inspection - Clinical laboratories ••• (June 2008)
p.(None): Annex III to Guidance for the conduct of GCP inspections - Computer systems ••• (June 2008)
p.(None): Annex IV to Guidance for the conduct of GCP inspections - Sponsor and CRO ••• (June 2008)
p.(None): Annex V to Guidance for the conduct of GCP inspections - Phase I Units ••• (November 2008)
p.(None): Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents ••• (March 2010)
...
p.(None): authorisation of the manufacturing or importation of such products
p.(None): Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for
p.(None): human use (OJ L 262, 14.10.2003, p. 22-26)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): e-newsletter Thu, 03/05/2020
p.(None):
p.(None):
p.(None): Put the horse before the cart: Investing in health requires investing in health workforce
p.(None):
p.(None):
p.(None):
p.(None): Latest updates
p.(None):
p.(None): Agenda - 86th meeting of the Pharmaceutical Committee (12 March 2020) •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Questions and answers (version 17) - Safety features for medicinal products for human use •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Documents - 85th meeting of the Pharmaceutical Committee (17 December 2019)
p.(None): Released 18 December 2019
p.(None):
p.(None):
p.(None):
p.(None): Follow us on More
p.(None): twitter
p.(None):
p.(None):
p.(None):
p.(None): Highlights
p.(None):
p.(None): Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Conference “Medicines for rare diseases and children: learning from the past, looking to the future” (Brussels, 17 June 2019)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products •••
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notice to stakeholders - Withdrawal of the United Kingdom and EU rules in the field of clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the
p.(None): framework of the Centralised Procedure
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notice to marketing authorisation holders of centrally authorised medicinal products concerning the United Kingdom's notification pursuant to Article 50 of the Treaty on
p.(None): European Union
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Related information
p.(None):
p.(None): Press material Videos
p.(None):
p.(None):
p.(None):
p.(None): Eurobarometers Events
p.(None):
p.(None):
p.(None):
p.(None): Consultations Publications
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public Health
p.(None):
p.(None): European Commission
p.(None): European Commission website
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): About the Commission's new web Resources for Privacy Legal Brexit content
p.(None): presence partners Cookies Policy notice disclaimer Contact
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Regulation and apply them to those clinical trials authorised under the Directive, to the extent possible and in compatibility with the legal framework of the Directive.
p.(None):
p.(None): Browse the theme
p.(None):
p.(None):
p.(None):
p.(None): Set of documents applicable to clinical trials authorised under Directive 2001/20/EC
p.(None):
p.(None):
p.(None): Set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable
p.(None):
p.(None):
p.(None):
p.(None): Set of documents applicable to clinical trials authorised under Directive 2001/20/EC
p.(None): General information ••• (July 2006)
p.(None):
p.(None): Chapter I - Application and application form
p.(None): Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial
p.(None): .
p.(None): Annex 1 revised : PDF version ••• - Word version ••• (revision 4 of November 2009 ; updated on 22 of November 2019). EudraCT Version 8.0 uses the Revision 4 dated November 2009 of the Clinical Trials
p.(None):
p.(None): Application Form (updated on November 22, 2019). For more information please refer to the EudraCT website.
p.(None): Substantial Amendment Notification Form : PDF version - Word version (revision 3 of June 2010)
p.(None): Declaration of the End of Trial Form : PDF version - Word version (revision 19 of June 2019)
p.(None): Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use ••• (revision 1 of February
p.(None): 2006)
p.(None): Detailed guidance on the European clinical trials database (EUDRACT Database) ••• (revision of April 2004)
p.(None):
p.(None): Chapter II - Safety reporting
p.(None): 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")
p.(None): ICH guideline E2F - Note for guidance on development safety update reports (September 2010)
p.(None):
p.(None): Chapter III - Quality of the investigational medicinal product
p.(None): Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries :PDF version - Word version (may 2013)
p.(None): Good manufacturing practice for investigational medicinal products
p.(None): Good manufacturing practices for manufacture of investigational medicinal products (February 2010)
p.(None): Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No
p.(None): 536/2014 (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
p.(None): Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
p.(None): Union Basic Format for Manufacturer's Authorisation (June 2013)
...
Orphaned Trigger Words
p.(None): "Questions & Answers" Document - Version 11.0 (May 2013)
p.(None): Ethical considerations for clinical trials on medicinal products conducted with the paediatric population:
p.(None): Original version ••• (2008)
p.(None): Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products
p.(None): List of fields contained in the "EudraCT" clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 ••• (June 2019)
p.(None): Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines
p.(None): Agency (EMA), in accordance with Article 41 of Regulation (EC) No 1901/2006
p.(None): List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 ••• (June 2019)
p.(None): Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
p.(None): Technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No
p.(None): 1901/2006 ••• (January 2013)
p.(None):
p.(None):
p.(None): EudraCT - List of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee) (November 2010)
p.(None): Chapter VI - Legislation
p.(None): Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of
p.(None): good clinical practice in the conduct of clinical trials on medicinal products for human use
p.(None): Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.(None): authorisation of the manufacturing or importation of such products
p.(None): Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for
p.(None): human use (OJ L 262, 14.10.2003, p. 22-26)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): e-newsletter Thu, 03/05/2020
p.(None):
p.(None):
p.(None): Put the horse before the cart: Investing in health requires investing in health workforce
p.(None):
p.(None):
p.(None):
p.(None): Latest updates
p.(None):
p.(None): Agenda - 86th meeting of the Pharmaceutical Committee (12 March 2020) •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Questions and answers (version 17) - Safety features for medicinal products for human use •••
p.(None):
p.(None): Released 09 March 2020
p.(None):
p.(None):
p.(None): Documents - 85th meeting of the Pharmaceutical Committee (17 December 2019)
p.(None): Released 18 December 2019
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| children | Child |
| home | Property Ownership |
| opinion | philosophical differences/differences of opinion |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input