These fields are essential to the The REC will only receive the EudraCT form. EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 1_Version 2.0 dated 29/07/15 Page 1 of 2 EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 5_Version 3 dated 01/02/2017 Page 1 of 2 Guidance Sheet 5: Transfer of babies to other hospitals for continuing care Trial activities (e.g. 3djh 2fwrehu ' ,1)250$7,21 21 ($&+ ,03 ,qirupdwlrq rq hdfk µexon surgxfw¶ ehiruh wuldo vshflilf rshudwlrqv eolqglqj wuldo vshflilf sdfndjlqj dqg Disk with the file for EudraCT containing the exact information . Further guidance on uploading data is available on the EudraCT website. The requestor now completes all the mandatory fields which are marked with (*). Our IT is working on this issue and hopes to solve it soon. Found inside – Page 683Food and Drug Administration Program, Compliance Program Guidance Manual, Chapter 48—Bioresearch Monitoring: Human ... Department of Health and Human Service, Food and Drug Administration, Statement of Investigator, FDA Form 1572. The register offers users the ability to search for information on any pa ediatric clinical trial, and any Phase II-IV adult clinical trial recorded in EudraCT. The format is YYYY-123456-78. To help us improve GOV.UK, we’d like to know more about your visit today. This section describes the steps needed for completing the IMP Identification of a Clinical Trial Application draft, concerning the identification of Investigational Medicinal Products to be used in the Clinical Trial, and their constituent active substances.. Search only database of 7.4 mil and more summaries . We apologise for this inconvenience and … The UK will continue to make information about trials being conducted in the UK available to the public, patients, researchers and clinicians via the HRA website and UK Clinical Trials Gateway. Further information can be found in the guidance document released in 2010 by the European Commission detailing the request to the competent authorities for CTAs. (10) This requires a EudraLink account. As a result, EudraCT and EU CTR websites will be unavailable to users between 18:30 hrs. It is therefore important that issues which This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the ... 2.1 05/05/11 Liesbeth Versteeg Revision due to the newly established emailbox to separate change requests from other ectd communications and small changes requested to the change control process. Please refer to European Guidance 2008/C 168/02 Art. The European Commission has laid down parameters for information in the EU’s clinical trial database, EudraCT, that could be made publicly accessible through EudraPharm, the database on medicines approved in the European Union. Found insideThe -CCMO is the Competent Authority for the purposes of the of EudraCT.152 The CBG takes care of the registration of the EudraCT Application Form in the European EudraCT database.153 – The Inspectorate for Health Care (IGZ) supervises ... The EudraCT … We use some essential cookies to make this website work. To obtain a EudraCT number: 1. Departments of University Clinics etc.). This guidance relates to clinical trials of medicinal products. Found inside – Page 101... identiffer for a clinical trial in the EU (the EudraCT number) the common (EudraCT) clinical trial application form accept ed in most Member States the common IMP dossier (IMPD) accepted in most Member States guidance documents with ... The EU Clinical Trials Register currently displays 41046 clinical trials with a EudraCT protocol, of which 6718 are clinical trials conducted with subjects less than 18 years old. ^���.��N��~�O?m#\ڣ� �a!8���d�4� o#|8 +��y�y�:��kc���\X�6��v:k��5ej��LJPVD�. Found inside – Page 64The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational Guidance Caroline Trouet. 1.3. APPLICATION FOR AN EUDRACT NUMBER (ONLY ... This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included. h��WYo�8�+|L�} E �nZ��.Z��-? EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 1_Version 2.0 dated 29/07/15 Page 1 of 14 EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 3_Version 5 dated 27/02/2018 Page 1 of 14 Guidance Sheet 3: IMP (a) Trial medication stock control Pharmacy the assigned trial stock is only possible if pack delivery and specified number of packs, Baby … The package sets out guidance and good practice standards, underpinned by standard documentation, so that individual NHS bodies can be confident that the process used to carry out criminal record and other checks on honorary researchers is in … "IEA, International Epidemiological Association, Welcome Trust." Guidance on the content of protocol-related and results-related information is available here: Guidance 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 Agency (EMA), in accordance with Article 41 of Regulation (EC) No 1901/2006 . 0 The register also displays information on 18700 older paediatric trials (in scope of Article … 3 para 2 . ¨ Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g. EudraCT, RDM, Eudrapharm, etc. Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials. Found insideIn addition, in 2003 and 2004 a range of guidance was introduced to spell out details on application forms and ... to the NCA and to the Ethics Committee the sponsor should obtain a unique EudraCT number from the EudraCT database. EudraCT Copy of the e-mail that confirms EudraCT-Nr. Once a EudraCT number has been obtained it is possible to use IRAS to complete the whole EudraCT dataset and to save the application in the format required for submission to MHRA. A copy of the allocation of the EudraCT number EudraCT is a database for all clinical trials within the European Economic Area (EEA), in which applications to all the European medicines agencies are filed. 2. endstream endobj startxref The sponsor submits the data required in electronic format to a Quarantine Area, from which the competent authority enters it into the Eudract database, by electronic transfer, after a confirmation check of the data. Found inside – Page 55Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial ... Detailed guidance on the European clinical trials database ( EUDRACT Database ) . QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in accordance with good manufacturing practice for medicinal products . Funder Name (WHO) All studies need funding even if they are self-funded. of detailed guidance CT-1 (if not contained in Part F of this form) Entire new version of the document11 Supporting information (*This will only come into effect from the time at which the request is processed in EudraCT). 4 4 European legislation (2) ... Eudract number - CTA request form - List of NCAs concerned - GMP certificate, labelling…. The EudraCT database was established in Article 11 of the Clinical Trial Directive 2001/20/EC [152kB]. Found inside – Page 68Chapter I, 'Application and Application Form', contains the application form and detailed instructions for the ... The application packages to CA and EC consist of the cover letter with the EudraCT number, the application form, ... Please state the GCP monitor in section G.5. Commission Guideline 2012/C 302/03 also provides further information on posting results. Guidance on arrangements in Northern Ireland has been published. The EU Clinical Trials Register currently displays 41046 clinical trials with a EudraCT protocol, of which 6718 are clinical trials conducted with subjects less than 18 years old. Found inside – Page 31EudraCT Number Step 1 The first stage in the process is to obtain an authenticated security code. This security code will be sent to the e-mail address specified by you, the requestor, on the form, and is needed in order to complete the ... human use. For detailed submission guidance, please see the . Found insideSupplementary remarks of the BfARM in addition to the Joint Notification by BfARM, BgW, and PEI of 4 Sept 1998—Guide for applicants (national Scientific Advice). 74. CIOMS IV form for reporting of serious unexpected suspected adverse ... Last Updated: 19 October 2020 * If you want to update the article please … Detailed guidance on the European clinical trials database (EUDRACT Database) Draft 5.3 Discussion in working group Dec 2001– June 2002 Release for consultation July 2002 Deadline for comments. 3. Guidance for the Submission and Conduct of Clinical Trials. It describes how the system can be used to obtain a EudraCT number and complete the Clinical Trial (CT) application form. 1.1.2. 1531 0 obj <> endobj Annex 1: Clinical trial Application Form C.1.5.1 Do you want a copy of the CTA form data saved on EudraCT as an XML file? The second, major part of the EudraCT system is based on a set of web pages that will collect the information required to complete the CT application, save the data to disc, print paper copies for the Member Advanced searches left . The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. References to PIM have been struck from the guidance since the project has been closed. The sponsor should then use this unique EudraCT number to create a EudraCT application form and should ensure that the data provided in the EudraCT application form and the XML file are identical and consistent with the protocol. GCP-V Section 3 §7 (2) 1 X X EudraCT Application Form – Module 1 (incl. %PDF-1.5 %���� Make sure you select the option for 'Full Import' Be aware that existing data in Parts A and B will be over-written; To import all data from EudraCT into a new IRAS project: Log into IRAS Introduction and Guidance for Use Version 2.1.3 – 16 November 2018 GENERAL PRINCIPLES AND INSTRUCTIONS FOR USE OF THE LISTS OF STANDARD TERMS The lists of Standard Terms were initially drawn up by the European Pharmacopoeia (Ph. As. NNNNNN is a six digit sequential number. Committee opinion on the clinical trial on medicinal products for. EudraCT Summarized by PlexPage. Find out more in our guidance. - News - PharmaTimes Further guidance on how to use the ARSAC Online Portal is available here From: … Module 2 of the Detailed guidance on the application format . contained on the printed CT application form handed to the The register also displays information on 18700 older paediatric trials (in scope of Article … an … xml) Eudralex X CT-1 X X Name of sponsor’s contact EudraCT Item B.1 Eudralex X CT-1 X X Specification of past SA EudraCT D.2.6 Eudralex X CT-1 X X The EudraCT database was established in line with the 'Medicines for Human Use (Clinical Trials) Regulations 2004'. Please submit a single copy of the form to the REC, together with all relevant enclosures. The time frame for posting the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials. We also use cookies set by other sites to help us deliver content from their services. Detailed guidance on the European clinical trials database (EUDRACT Database) [230 KB] (revision of April 2004) 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 [1022 KB] Translations . The same EudraCT number shall be used for multinational multicenter studies in all countries. 3 – Guidance on Power of Attorney and No. You can watch a recording of the Clinical Trials webinar which took place on 21 October 2020. This book covers all the important dermatological aspects that should be considered in diagnosis and treatment of recipients of solid organ and hematopoietic stem cell transplants. Include the name of the organisation that the requestor works for in this field. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. The Import / Export tab is only available on the MHRA Medicines (EudraCT application) form which you will need if you are applying for a Clinical Trial Authorisation (CTA) for a clinical trial of an investigational medicinal product (CTIMP). Form FDA 3674 – Instructions. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging ... e-mail – posta@sukl cz or (always with identification of the Clinical Trial by EudraCT number and SÚKL ... further details are described in guideline KLH-20, Annex No. Since then changes to the EU pharmaceutical legislation (Article 57 of Regulation (EC) No 726/2004 [207kB] and Article 41 of the Paediatric Regulation (EC) No 1901/2006 [203kB]) allow some of the information held in the EudraCT database is to be made public. Extract from the amended document in accordance with Section 3.7.c. All substantial amendments should be approved in principle by the sponsor(s) before submission. This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. IRAS is designed to be an intuitive system which all applicants can learn to use with the aid of comprehensive on-line guidance, supported by the Helpdesk and other published sources of advice on applications. The expectation is that all clinical trials must be registered. Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. If you have already created and downloaded an Annex 1 form (PDF and XML) in EudraCT before the end of the year, this will be accepted. If you have access to any of the following systems, you already have an active EMA account: Clinical Trials Information System (CTIS), SPOR, Eudralink, EudraCT Secure, Service Desk portal, European Union telematics controlled terms (EUTCT), Meeting Management System (MMS), Managing Meeting Document system (MMD), EudraVigilance data analysis system (EVDAS), EudraPortal, European Union … References to PIM have been struck from the guidance since the project has been closed. You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial. This number identifies the protocol for a trial, whether conducted at a single site or at multiple sites in … However, in exceptional circumstances non-registration may be permissible with prior agreement from the Health Research Authority (HRA). highlighted in yellow. Please note the research protocol is only required for studies involving therapeutic nuclear medicine procedures. “Requestor’s organisation name”. A EudraCT number is a unique identifying number allocated to your trial. It is mandatory for all studies starting in the European Community on or after the 1 May 2004 involving the use of an Investigational Medicinal Product (IMP) to have a EudraCT number and to be registered on this database. (10) This requires a EudraLink account. The completed Notice of Substantial Amendment form should be authorised using electronic authorisation in IRAS. In addition to the above trials, … We’ll send you a link to a feedback form. Found inside – Page 18311.5.8 EUDRACT [13] EudraCT is a database of all clinical trials which commenced in the European Community from May ... the EudraCT application in order to: • Obtain a EudraCT number • Submit the clinical trial application form to the ... Further details and guidance about this will be provided shortly. If item E.8.7 of the EudraCT form is ticked, which indicates that the trial has an independent data monitoring committee, please submit the committee charter. The submission of the form for … an updated risk/benefit assessment). The information presented in this book also facilitates communication across conventional disciplinary boundaries, in line with the increasingly multidisciplinary nature of modern research projects. This text is a resource for both the basic life science and cell therapy researchers and includes a spectrum of review chapters from top experts in the field discussing clinical scale culture, regulatory issues, genetic engineering, disease ... This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Don’t worry we won’t send you spam or share your email address with anyone. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Extract from the amended document in accordance with Section 3.7.c. EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 4_Version 4.0 dated 23/08/18 Page 3 of 6 Form 2: Trial Medication Form Complete the form 7 days after the baby has completed trial medication, or if the Can be used as content for research and analysis. Found inside... of the authorisation together with a submission of the essential documents (including the EudraCT application form). ... of the Board of Directors of INFARMED (“Resolution 94/CA/2005”) — approving the detailed guidance intended to. Transparency measures will be strengthened under the new EU Clinical Trials Regulation (CTR) 536/2014. EUDRACT USER MANUAL V7.0 (PUBLIC WEBSITE) Doc id:EMEA/50074 1/2006 1 ABOUT THIS DOCUMENT This document describes the public website used to make an application for a Clinical Trial. ÷ƒ‡½[U)½9ʳhî‡i„”{тV|Ò%Ý ñf(gà~Ûw vÈÖAª´²ÄW Kö`šwƒMjƒQâý •Î€,)—0ËT(] jÉZe"x0,U²‚þC@ë IRAS is designed to be an intuitive system which all applicants can learn to use with the aid of comprehensive on-line guidance, supported by the Helpdesk and other published sources of advice on applications. 2.2. The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V10, marks the final step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR). Representative of the sponsor are both in the CT1 guidance attached and in the Directive as well. Following a no-deal Brexit, in the short term, you should continue to use existing and established international registers such as EudraCT (EU), ISRCTN (International Standard Randomised Controlled Trial Number) register (UK), and ClinicalTrials.gov (USA) to ensure that UK patients are aware of your trial. EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. Module 1: Administrative information Application form User guide for the electronic application form for a Marketing Authorisation Purpose and general rules ... further guidance on process for confirmation of eligibility to centralised procedure and Rapporteur appointment. Due to the interdisciplinary nature of the subject area this volume will be of special interest to physicians, biologists, chemists, engineers, and physicists as well as to students in the respective fields. In the UK, any approval by a research ethics committee is subject to the condition that all clinical trials must be registered on a publicly accessible database. Preceded by ADHD rating scale-IV / George J. DuPaul ... [et al.]. 1998. From a practical point of view you need to follow the : EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 4/33 : Item no. Proactively interacts with other Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. The Clinical Trial Application (CTA) form is also created via the EudraCT system. The EudraCT form should be completed in English with the exception of contact information on Austrian sponsors, legal representatives, request for the competent authority, the study sites and clinical investigators (e.g. If applicable, supplementary information/documents can also be included in the submission (e.g. 2.1 05/05/11 Liesbeth Versteeg Revision due to the newly established emailbox to separate change requests from other ectd communications and small changes requested to the change control process. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Detailed guidance on the European clinical trials database (EUDRACT Database) [230 KB] (revision of April 2004) 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 [1022 KB] Translations . If the amendment entails changes to the originally submitted EudraCT application form, an updated EudraCT application form must be submitted, in both XML and PDF format. Select the MHRA Medicines (EudraCT application) form from the list of forms on the main navigation screen; Follow the instructions under the Import/ Export tab. 1570 0 obj <>stream The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator. This practical text guides the reader in developing the necessary tools for teaching those patients with limited literacy skills. … Welcome to the EudraCT public home page. While the focus of the report, and its concrete recommendations, are targeted primarily on the UK, we have thus sought to ensure that our ethical analysis and conceptual recommendations have as wide a resonance as possible."--Page xv. They can obtain the number and guidance from the ... C.1.5.1 Do you want a copy of the CTA form data saved on EudraCT as an XML file? It will take only 2 minutes to fill in. Process: Tutorials on posting results (step 2 documents: primary user request form, guidance for completing, service level agreement ), Frequently asked questions (see section on results information). h�bbd```b``���A$S,�d�f��e'�Iq�h The EudraCT number is used as the unique reference to a clinical trial on the CT application form. Version details. You can change your cookie settings at any time. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. Found inside – Page 36536/2014 has been implemented, which encompasses the legal form of afore-mentioned directives. ... The CTA process will require that the applicant to obtain a unique EudraCT number from the EudraCT Community Clinical Trial System by ... h�b```�e��J� ��ea���$�p�%�s�� ��ǻg�u��( �Q�(-~j�$9�[����L%:::8:2���a� �8::P������H����FV�T��LL��2:3�1}g��,�zLQg��K�gY20������>6 ��R,��g`�h�n��S``����b� 0 V�1� Data may … From the EudraCT Welcome Screen take the link: „Apply for EudraCT number‟ 2. When the EudraCT application form is updated, this is not considered a resubmission. Don’t include personal or financial information like your National Insurance number or credit card details. In the detailed guidance for the application form to the Ethics Committees references are given to the ‘Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities in the European Union, EudraCT, RDM, Eudrapharm, etc. However, we will align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. Collected from the entire web and summarized to include only the most important parts of it. This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. A EudraCT number is a unique identifying number allocated to your trial. form, in annex to the same Detailed guidance. Declaration of the End of Trial Form: PDF version (revision 3 of June 2010) Annexe 1 revised Pdf version [86 KB] (revision 4 of November 2009) – EudraCT Version 8.0 uses the Revision 4 dated November 2009 of the Clinical Trials Application Form. Form FDA 3674. Key guidance and documents . In terms of dossier content, the EudraCT form, the protocol, the investigator brochure (IB) and the Investigational Medicinal Product Dossier (IMPD) are the main components of the CTA. Commission Guideline 2012_C 302_03.pdf Eur.) Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new ... In order to determine whether the action you are taking is an Urgent Safety Measure ( USM) please refer to section 3.9 and 3.10 (142-150) of guidance document CT-1. Confirmation of 3. EudraCT and EU CTR application maintenance weekend 18 to 20 June 2021. 1554 0 obj <>/Filter/FlateDecode/ID[<13E6CE4C6F232441969F3B89067658F3>]/Index[1531 40]/Info 1530 0 R/Length 112/Prev 179949/Root 1532 0 R/Size 1571/Type/XRef/W[1 3 1]>>stream Before submitting an application to the national competent authority, the applicant should obtain a unique EudraCT number from the EudraCT Community Clinical Trial System (19) by the procedure described in the current version of the Detailed guidance on the European clinical trials database (20). for adult phase 1 studies), they should contact hra.studyregistration@nhs.net. )a�a� c,��:���,HlS�C�r��Ž`�SG2K:V1o���P�� ���X��c�r��Lqm�楑l����t�̀���u��y�{����e�|�|1�e�"/v����9���Eo�z�.�я�z�-`����m�p 87I8e.M�ɤ��?f��K��� ���R��n�>o�N�V���v��� !���]��绋�n�_FV>�h�$�@��t�%�/�o{��(z?��Q�Ɋ����j�H��z�ihX�����|�g�'�"[�ŜIƻuF��&_�M�w���q�P�'���-�.�YŤ�N�Շ��>]'��&�\)���A�я�ce���>��a"���0�O�����̈́`U��h�1�6�������i5 �1^��@���-s�@I�0��xP����>�J�2���pmD�9&�Ud���>$�q��A�C���*e�oW�� �#@R���d �\����/{�m^���Ͷ迤�jZ������0|��͏��je´3�f��v"�e��J1%$� p���g��4��3�tR� i��L�; A���w�Y��Qp�y�S�q@���:�'hЀ����D%,hF�Ը*�9�$��4g The application forms require that Adobe Acrobat reader be installed on the PC. This is freely available from Adobe and can be downloaded from their site www.adobe.com or through a link on the EudraCT documentation page. 3.2 Data Entry Formats Also refer to section 7.2 Data Conventions when Completing the CT Application Form. 3.2.1 General Concepts This detailed guidance is based on Article 9(8) of 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 good clinical practice in … CC is a check digit. For more information please refer to the EudraCT website; Chapter II: Monitoring and Pharmacovigilance. If you have any queries, please contact us at cwow@hra.nhs.uk. INDs/CTAs and NDAs/MAAs/CTDs). A Mutual Recognition Procedure of detailed guidance CT-1 (if not contained in Part F of this form) Entire new version of the document11 Supporting information (*This will only come into effect from the time at which the request is processed in EudraCT). Health Literacy: Prescription to End Confusion examines the body of knowledge that applies to the field of health literacy, and recommends actions to promote a health literate society. If you have any questions, please contact us at cwow@hra.nhs.uk. You will need to obtain a EudraCT number for this application. If the substantial amendment is applicable to several clinical trials, the EudraCT … The CTA shall be submitted in a printed form and the EudraCT application in an .xml format on a CD. align transparency provisions with those currently operating in the EU, in order to eliminate the need for companies to duplicate efforts. The CTA submission must be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf). Guidance on requirements for Site-Specific Assessment for non-NHS sites is available within the question-specific guidance on the SSI Form for non-NHS sites, and on the Health Research Authority (HRA) website resource page. The Import / Export tab is only available on the MHRA Medicines (EudraCT application) form which you will need if you are applying for a Clinical Trial Authorisation (CTA) for a clinical trial of an investigational medicinal product (CTIMP). EU law requires that the sponsor of a clinical trial or a legal representative must be established in the EU. No 1901/2006), or if they form part of an agreed PIP (Paediatric Investigation Plan) .