Guide to EU Clinical Trial Application Form

Transcription

1 Deleted: <object> Guide to EU Clinical Trial Application Form SCOPE This user guide has been prepared to help applicants complete the application form to the HPRA for authorisation of a clinical trial using an investigational medicinal product (IMP) for human use. Deleted: (IMP) Application forms are available through the internet, from the EudraCT website, which is part of the EMA s website and is a central EU clinical trial database. The EudraCT website gives full directions on obtaining a security code, after which it is possible to apply and obtain a EudraCT number for each trial. This number, and the confirmation of the number, must be included in the application. Applicants must also complete the EU application form on-line at the EudraCT website, save it electronically as an.xml file and include it in the application. This website will also allow you to print the completed application form for it to be signed. Applications which do not comply with the new requirements will not be validated. Some sections of this application form are not applicable when applying to the HPRA; these sections are highlighted in this guide. This guide follows the format of the EU application form. Further information and a list of documents for submission with clinical trial applications are detailed in the Guide to Clinical Trial Applications (Appendix 3) available from the Publications and Forms section of SECTION A TRIAL IDENTIFICATION It is necessary to obtain a EudraCT number from the EudraCT database before making an application to the HPRA. This number is unique to each clinical trial. The number may be obtained from the website of the European Commission. Moved (insertion) [1] Deleted: Please note that there is also an additional Moved down [2]: HPRA Deleted: which must also be completed Deleted: each application. This form Additional national requirements for a Deleted: application is Moved up [1]: This guide follows the format of the EU Deleted: application form. Give the full title of the trial and any abbreviated name or title. Indicate the ISRCTN (International Standard Randomised Controlled trial number) only if it is available. An ISRCTN can be obtained from registering any randomised controlled trials on the Controlled trials website. AUT-G /6

2 SECTION B IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE REQUEST Give details of the legal representative if the sponsor is not established in the EU. Established means that the company has a registered office, central administration or principal place of business within the EU. The legal representative must be established in the EU. A commercial sponsor is defined as a person or organisation that takes responsibility for a trial which is part of the development programme for a marketing authorisation, including postmarketing trials. Trials conducted by non-commercial sponsors are typically investigator-led trials. SECTION C APPLICANT IDENTIFICATION C1 Request to competent authority This section should be completed by the person or organisation making the application, who may be the sponsor, his legal representative or a company authorised by the sponsor to make the application e.g. consultant research organisation. Deleted: to C2 Request to Ethics Committee Do not complete this section for applications to the HPRA. SECTION D INFORMATION ON INVESTIGATIONAL MEDICINAL PRODUCT(S) BEING USED IN THE TRIAL: MEDICINAL PRODUCT BEING TESTED OR USED AS A COMPARATOR Provide information in sections D1 and D2 on each IMP, including any comparator(s). Give each IMP a sequential number and repeat the sections for each product. Deleted: investigational medicinal product ( Deleted: ), Provide information on the placebo in section E, not in this section. D1 Status of the IMP to be used in the trial Member States are countries in the EU; third-countries are countries outside of the EU. If the IMP is authorised in a number of third countries, only indicate the country from which the batch(es) to be used in the trial are taken. Indicate if the IMP has been used in any previous trial conducted by the sponsor anywhere in the EU. /5 AUT-G /6

3 Orphan drugs are those which have been designated according to Regulation (EC) N 141/2000. A list of designated orphan drugs and designation numbers is available on the website of the European Commission. D2 Description of IMP The product name refers to the name of the active substance. The product code is a set of numbers and/or letters which may be used to describe an active substance before a common name is available. Any current code should be stated in the second line and any previous code in the fourth line. It is important that all designations of the active substance are stated. INN means the International non-proprietary name issued by WHO. CAS is the Chemical Abstract Service name. For established active substances, both names will be available in standard reference books such as Martindale s The Extra Pharmacopoiea. The ATC is the Anatomical Therapeutic Chemical classification of substances. The ATC code is issued by WHO Collaborative Centre for Drugs Statistics Methodology in Oslo. For authorised products, the ATC code is available in the Summary of Product Characteristics. Describe the pharmaceutical form and route of administration using the Standard Terms of the European Pharmacopoeia. Type of medicinal product Indicate if the IMP is of chemical origin or of biological/biotechnological origin. Depending on the active substance, the other listed categories may or may not be applicable. Deleted: is If the IMP contains active substances of biological/biotechnological origin, complete section D3 (vaccines), D4 (somatic cell therapy) or D5 (gene therapy) as appropriate. SECTION E INFORMATION ON PLACEBO Complete only for trials that involve the use of a placebo. Repeat as necessary if there are different placebos for the tested product and comparator(s). If the placebo is not identical to the IMP (apart from the absence of the active substance), give the names of major ingredients only. The full composition is given in the IMP dossier. /5 AUT-G /6

4 SECTION F AUTHORISED SITE RESPONSIBLE IN THE COMMUNITY FOR THE RELEASE OF THE IMP IN THE COMMUNITY State the name of the responsible site in the first line of the first box (and repeat in the third box). Indicate whether the company is a manufacturer, or importer only where the product is imported from a third country (i.e., a country outside the EU). No manufacturing authorisation may be available if an authorisation is pending or if the site is exempted under point 42 of Annex 13 to the GMP guide. Repeat the information for each site responsible for release of the finished IMP and for each IMP. SECTION G GENERAL INFORMATION ON THE TRIAL Medical condition or disease under investigation Specify the medical condition in your own words. Give at least one of these two classification codes, ICD10 and/or MedDRA. ICD10 is the International Statistical Classification of Diseases and Related Health Problems, issued by WHO. MedDRA is the Medical Dictionary for Regulatory Activities, the global standard medical terminology, issued by the MedDRA Maintenance Organisation. Classify the disease as rare or not according to the guidance given in COMP/436/01 Points to consider on the calculation and reporting of the prevalence of a condition for Orphan drug designation. Trial type and phase Describe according to the trial classifications in the Note for Guidance on General Considerations for Clinical Trials (CPMP/ICH/291/95 - adopted Sept. 97). Design of the trial For multi-site trials, answer both the section on multiple sites and multiple Member States and complete section I also. Third countries are countries outside the EU. /5 AUT-G /6

5 Define the end of the trial and justify the definition if it is not the last visit of the last subject only if this is not given in the protocol. SECTION H POPULATION OF TRIAL SUBJECTS Give plans for post-trial treatment if different from the expected treatment for the relevant condition only if not given in the protocol SECTION I PROPOSED CLINICAL TRIAL SITES IN THE MEMBER STATE CONCERNED BY THIS REQUEST For a trial at a single centre, the sole investigator is the principal investigator. For a multi-centre trial, the co-ordinating investigator is the person responsible for coordinating the work of several principal investigators working at different trial sites in Ireland. For these trials, principal investigators are the investigator at each trial site, whether working on their own or with a team. If there is more than one independent investigator at a trial site, each is a principal investigator for the purposes of filling out the form. It is not necessary to include details of the members of a team reporting to a principal investigator. For other principal investigators, repeat the information as necessary in the form itself. Do not attach other pages. The addresses given should be the address of the trial site(s). Repeat the information on central technical facilities and/or on trial monitoring facilities (e.g. CROs) if there are multiple sites. SECTION J COMPETENT AUTHORITY/ETHICS COMMITTEE IN THE MEMBER STATE CONCERNED BY THIS REQUEST Tick the box for ethics committee only and give details of the committee and the status of the application to it. SECTION K CHECK LIST FOR THE INFORMATION APPENDED TO THE APPLICATION FORM Tick both columns to show information provided to the ethics committee and to the HPRA. For information required by the HPRA, see appendix to this guide. /5 AUT-G /6

6 SECTION L SIGNATURE AND PRINT NAME OF THE APPLICANT IN THE MEMBER STATE Sign only the request to the competent authority. HPRA 22 December 2016 Moved (insertion) [2] /5 AUT-G /6