3 RESPONSIBILITIES AND AUTHORITIES

Transcription

1 Amendment submission to Ethics Committee and competent authorities (FAMHP) N : CEHF-SOP-015 / REV008 N ENGLISH VERSION : 061 "Please do take into account that this is a translation of the original French version validated in the Quality Management System (QMS) of Cliniques universitaires Saint-Luc through the software Ennov GED. Therefore in case of doubt, differences, inconsistency or discrepancy in this English version, the French version shall prevail" 1 PROCEDURE S OBJECT This procedure describes the steps to follow to submit a substantial or not substantial amendment to CEHF and FAMHP. 2 PROCEDURE S SCOPE 2. Consultations 3. Medico-technic 4. Ward and One-day clinic 6. Paramedics 8. Comité d'ethique Hospitalo-Facultaire (CEHF) 3 RESPONSIBILITIES AND AUTHORITIES The sponsor: Determines if the amendment is substantial or not. Page 1 sur 10

2 Each amendment must be designated by a reference number only referring to this amendment, allowing a clear distinction between the other modifications of the project. A substantial amendment can consist in multiple modifications. Uses the internal reference number attributed by the EC to all clinical research project for all subsequent correspondence/contacts with this latter. Ex : modification of the informed consent form Substantial amendment: o Provides the investigator with the requested documents for the submission to the EC. (see circular 575 FAHMP for more information : o Submits the amendments for approval by the FAHMP Non-substantial amendment: Ex: administrative corrections in the protocol, address change of the sponsor, These modifications are listed and sent separately to the EC (Leading or Non-Leading) and FAMHP with the investigator s brochure upon the annual update. The investigator: Controls (or delegates this task to the study coordinators) all documents (versions and dates) related to the clinical research project and the presence of all requested annexes before submitting to the CEHF. Submits the documents received from the sponsor to the Ethics Committee for approval (LEC) or for notification (NLEC). Creates the submission (substantial amendment, non-substantial amendment, amendment notification (NLEC)) in the database Claire before sending the documents to the EC. The ethics committee: Evaluates the substantial amendment (ex: change of investigator) received for opinion in case of monocenter experiment and LEC (single opinion) in case of multicenter experiment. Receives the substantial amendment for notification when NLEC Particular amendment: The proposal of extension to new site to a multicenter experiment: the LEC must contact the NLEC to get their opinion on the investigator and collaborators as long as the quality of installations. The NLEC are not requested to give opinion on the ICF already approved at the time of initial submission if EC from different languages participated to the submission process. After a definitive approval of an EC, no additional site can be added during 3 months except if the center was included in the initial submission (see circular 613). Page 2 sur 10

3 Non-substantial amendment when CEHF is LEC: administrative corrections in the protocol, changes in the sponsor address etc, are listed and sent separately to the Ethics Committee (Leading or Non Leading) and to the FAMHP with the investigator brochure during the annual update. The CEHF sends an acknowledgement of receipt. When the CEHF is LEC, the CEHF evaluates whether the management of information from the sponsor that is relevant to the protection of participants is adequate. 4 PROCEDURE S REVISION 5 PROCEDURE S DESCRIPTION Page 3 sur 10

4 5.1 Documents to provide to the CEHF for any substantial amendment (for opinion in case of LEC, for notification in case of NLEC): COMMERCIAL EPERIMENTS Document Ref doc Explanation Amendment form for drug clinical trials Old and new versions of documents highlighting modifications New version of the protocol Other useful information / Billing sheet Acknowledgement of receipt of valid application a.europa.eu/eudra ctweb/index.faces For clinical trials with medicinal poroduct ONLY. Signed by the principal investigator Mandatory version Pap. Elect. / A paper version is only requested if the amendment concerns the consent forms / Protocol modifications in tracked changes CEHF-FORM-006 CEHF-FORM-007 summary of data, global analysis of risks/benefits, possible consequences for subjects already enrolled in the experiment, possible consequence on evaluation of results, unanticipated problems involving risks to participants or others, and interim results. ONLY FOR THE LEC Don t provide it to the NLEC This document is provided and completed by the sponsor The principal investigator checks o the content o dates and versions conformity signs it sends it to the CEHF Page 4 sur 10

5 Document Ref doc Explanation Version Pap. Elect. CV of new investigators / ONLY FOR THE REQUEST OF ADDITIONAL SITES Principal investigator and Sub-investigators Date and sign their CV Information sheet of clinical research project submitted to CEHF CEHF-FORM-005 ONLY FOR THE REQUEST OF ADDITIONAL SITES Page 5 sur 10

6 5.2 Documents to provide to the CEHF for any substantial amendment (for opinion in case of LEC, for notification in case of NLEC): NON-COMMERCIAL EPERIMENTS Document Ref doc Explanation Amendment form for drug clinical trials Old and new versions of documents highlighting modifications New version of the protocol Other useful information / Acknowledgement of receipt of valid application a.europa.eu/eudra ctweb/index.faces For clinical trials with medicinal poroduct ONLY. Signed by the principal investigator Mandatory version Pap. Elect. / / Protocol modifications in tracked changes CEHF-FORM-007 summary of data, global analysis of risks/benefits, possible consequences for subjects already enrolled in the experiment, possible consequence on evaluation of results, unanticipated problems involving risks to participants or others, and interim results. This document is provided and completed by the sponsor The principal investigator checks o the content o dates and versions conformity signs it sends it to the CEHF Page 6 sur 10

7 Document Ref doc Explanation CV of new investigators / ONLY FOR THE REQUEST OF ADDITIONAL SITES Principal investigator and Sub-investigators Date and sign their CV Version Pap. Elect. 5.3 Submission of substantial amendment by the sponsor to the FAMHP: NON-COMMERCIAL CLINICAL TRIAL WITH INVESTIGATIONAL MEDICINAL PRODUCT No fees for FAMHP or EC for non-commercial experiments. Same timing is applicable for approval than for new submission. - Cover letter signed, specifying the reason of the substantial amendment. This letter should mention the EudraCT number, the protocol number, the title, the amendment number and the date. - European amendment form : (document type : - When the amendment requires a modification of the initial application form (.xml), this modification must be incorporated and a revised copy should be joined to the file. - Old and new versions highlighting the modifications - New modified version of the protocol - Other useful information : summary of data, global analysis of risks/benefits, possible consequences for subjects already enrolled in the experiment, possible consequence on evaluation of results Page 7 sur 10

8 Concretely, an electronic version (CD) of all the documents listed above along with a cover letter (signed) has to be sent by registered mail to: Federal Agency for medicines and health products Head of Division Recherche et Développement Bâtiment Eurostation, 8 ème étage Place Victor Horta 40, boîte 40 B-1060 Bruxelles FILE FORMAT The documents sent electronically should be exclusively under pdf format, except the «European Application Form» which should be sent also under.xml format (also in pdf). The version of the European Application Form must be saved in two steps: - one part corresponding to the entire form - one part corresponding to the signed scanned page The file must allow copy-paste and other manipulations. Documents with signature must be scanned. A table of content must allow to access easily to the chosen section. Files must not be secured by password. Each piece of the project must be a distinct file. FILE NAME - To name the different files under pdf format : Number Eudract-Name of file.pdf - To name signed scanned pages : Number Eudract-Name of file-signature.pdf - To name a document refering to a particular drug (experimental or authorized): Number Eudract-Manufacturing Autorisation-Name of drug.pdf Page 8 sur 10

9 Examples: Covering-Letter.pdf, Application-Form.pdf, Application-Form.xml, Application-Form-Signature.pdf, Protocol.pdf, Simplified- Impd.pdf, Smpc.pdf, Labels.pdf 5.4 Documents to be provided by the sponsor to the FAHMP for any substantial amendment: non-commercial experiment with a non- CE registered or off-label used medical device After having received the approval of the Ethics Committee for the concerned amendment, the sponsor sends an for notification to the following address: ct.rd@afmps.be The following information must be reported in this Medical device and class Manufacturer (or «Authorized Representative» if the manufacturer is not established in the Community) Sponsor of the study Title of the study FAHMP reference of the study concerned by the amendment Summary of the changes brought by the amendment and documents where the changes can be found Copy of the Ethics Committee approval for the submitted amendment 6 DEFINITIONS AND ABBREVIATIONS EC : Ethics Committee CEHF : Comité d Ethique Hospitalo-Facultaire Saint-Luc UCL FAMHP : Federal Agency for medicines and health products ICF : informed consent form LEC : leading EC NLEC : non leading EC Page 9 sur 10

10 «Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial Journal Officiel de l Union Européenne of 30 March (definition C148/20 and followings) An amendment is considered as substantial when it is susceptible to have important incidences on safety or physical or mental integrity of participants, or on the scientific value of the experiment. The amendments can be related to the protocol, the organization of the experiment, the investigational medicinal product, modifications of phamarcological or toxicological data relevant for the ongoing experiment, modifications in ongoing clinical trials as well as data collected from human experiment. 7 REFERENCE DOCUMENTS CEHF-DSQ Check list submission amendment substantial commercial experiment, CEHF-DSQ Check list submission amendment substantial non commercial experiment, CEHF-FORM-005 Contact information sheet CEHF, CEHF-FORM-006 Billing information CEHF, CEHF-FORM Acknowledgement of receipt of valid application, 8 AAHRPP ACCREDITATION STANDARDS II.2.D III.2.C 9 LINKS INTRANET 10 LINKS INTERNET Page 10 sur 10