Application date : 07/07/2014 Procedure for submitting a new clinical research project. Véronique Baudewyns

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1 Page 1 / 10 Author Service de la Recherche Biomédicale Reviewer(s) Véronique Baudewyns Approved by Jean-Michel Hougardy Public All Investigators Study Nurse Study coordinator Paramedics Admin Staff Document revision history / Changes-Revision Comment Revision on May INTRODUCTION PURPOSE OPERATION OF SINGLE ENTRY POINT...1 PREPARATION OF SUBMISSION FILE BY PI... 4 VERIFICATION OF THE FILE AND ASSIGNMENT OF A UNIQUE NUMBER... 8 SUBMISSION TO CE / CONTRACT MANAGEMENT / INSURANCE... 8 CONSOLIDATION AND SIGNATURE... 9 «GREEN LIGHT» LETTER SUBMISSION OF FINAL WORK (TFE) REFERENCES APPENDICES INTERNAL LINKS EXTERNAL LINKS Introduction The establishment of a Single Entry Point meets the need to centralize the process of submitting new clinical research to the Clinical Trial Centre (CTC) and the Ethics Committee of Hôpital Erasme and the medical school of Université Libre de Bruxelles (EC). This new process allows us to have a global and comprehensive view of the various research s that take place at Hôpital Erasme and to ensure the safety of the participants by respecting our HRPP accreditation. 2. Purpose The purpose of this procedure is to define the stages of submission of a clinical research at Hôpital Erasme. 3. Operation of Single Entry Point All clinical research s involving patients from Hôpital Erasme or performed on healthy volunteers at Hôpital Erasme must be submitted to the "Single Entry Point" of the Biomedical Centre. The latter is responsible for verifying the presence of all documents necessary for the analysis and processing of the file, in accordance with the procedure outlined below. The CTC then submits the complete file to the Hospital-Faculty Ethics Committee of Hôpital Erasme. If necessary, additional information on the file will be requested from the principle investigator (PI). The contractual and budgetary review will be carried out by the CTC, in parallel with submission to the EC. A consolidation phase is then

2 Page 2 / 10 carried out by the CTC, thus ensuring that all required elements (insurance, contract, EC agreement, FAMHP agreement, registration on Clinicaltrials.gov,...) are in order. Once the consolidation phase is completed, the contracts are signed by the various parties involved. The investigator will be able to start his study upon receipt of the "green light" letter.

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4 Page 4 / 10 Preparation of submission file by PI All clinical research s must be submitted to the CTC through its Single Entry Point. All the documents required for the analysis and processing of the application (see Tables 1A and 1B below) must be provided: Electronically at the following address: Service.Rech-biomed@erasme.ulb.ac.be. For practical reasons, it is advised by the EC that these files are provided exclusively in.pdf format or in.doc format (without protection through password). And as a paper file containing all documents classified and grouped according to the following 3 items and in the following order: Administrative documents Documents related to the protocol Additional documents for members of the ethics committee This paper version is to be submitted to the CTC. From a practical point of view, and for reasons of security and confidentiality, the CTC favors handdelivery. However, investigators who work in the hospital will be able to use postal sorting (internal mail) in order to submit their files. In this case, of course, account must be taken of the processing time and the possible loss of confidentiality of the files, for which the CTC cannot be held responsible. The Biomedical Department (local CAH-3W-1040) is located on the 3rd floor of the CAH (Centre Administratif Hospitalier) building. From the main building of the hospital, go to the day hospital, cross the parking lot of the day hospital and take the small road between the nursing school (on your right) and the Sport hospital (on your left). The CAH building is located behind this road.

5 Page 5 / 10 Monday Between 9h00 and 12h00 and between 14h00 and 16h00 Tuesday Between 9h00 and 12h00 and between 14h00 and 16h00 Wednesday Between 14h00 and 16h00 Thursday Between 9h00 and 12h00 and between 14h00 and 16h00 Friday Between 9h00 and 12h00 and between 14h00 and 16h00 Files may be submitted by both the Principal Investigator (PI) and the sponsor or other contact person (Clinical Associate) to whom the submission procedure has been delegated. In this case, the file will contain, on penalty of inadmissibility, a written power of attorney justifying such delegation.

6 Page 6 / 10 Depending on the type of research, the folder must contain the following documents: Documents associated with submission Commercial studies Commercial Administrative documents Documents related to the protocol CV Info on CHRAU or local EC list Insurance certificate draft contract Excel tables of costs/activities/visits (flow chart) Copy of the AFMPS (device) submission form or CE approval certificate Copy of the European Clinical Trial Application or EudraCT application form Retrospective x x x x x x x x x x x x x 3 Proof of CE payment Proof of AFMPS payment Cover letter GCP certificate Attestation to honor Net ID Letter of approval from department chair Synopsis of the (max. 1 page) Internal Registration Form 2 copies of DACE / ECAF Protocol and amendments Observation notebook / CRF 2 copies of ICF FR and 1 copy of ICF NL Patient journal Questionnaires If healthy volunteers: recruitment procedure (poster, advertising) + information on the payment or compensation MCH x x x 2 x x x x x x x x x x 3 x 4 Prospective x x x x x x x x x x x x x x x x 4 x 4 x x 4 Device x x x x x x x x x x x x x x x x x 4 x 4 x x x 4 Observational test x x x x x x x x x x x x x x x x x 4 x 4 x 4 Interventional test x x x x x x x x x x x x x x x x x x x 4 x 4 x x x 4 x1: non-applicable if study is monocentric x2: if prospective x3: unless exempted x4: if available All documents must be provided electronically. As requested by the EC, the documents covered by the gray boxes must be provided in paper form in addition to the electronic version. Note on studies involving minors: if the EC is responsible for the opinion (single-center study or CHRAU in a multicenter study), it will be necessary to add 2 copies of: the form for requesting an opinion to the Ethics Committee the protocol Information and informed consent forms for the parents of the minor and the minor. Investigator Brochure Manual (lab, radio, anapath, ) Table 1A. Commercial Studies

7 Page 7 / 10 Documents associated with submission Non commercial studies (academic) Academic Administrative Documents Documents related to the protocol CV Info for CHRAU or local EC list Application for insurance (Erasmus sponsor) or insurance certificate Draft Contract Copy of the letter for the Federal Commission on embryos Copy of the AFMPS (device) submission form or CE approval certificate Copy of the European Clinical Trial Application or EudraCT application form Retrospective x x 1 x 1 x x x x x x x x 3 GCP Certificate Attestation to honor Net ID Letter of approval from the department chair Synopsis of the (max. 1 page) Internal registration form 2 copies of DACE / ECAF Protocol and amendments Notebook / CFR 2 copies of ICF FR and 1 copy of ICF NL Patient journals Questionnaires Investigator brochure / Instructions for use If healthy volunteers: recruitment procedure (poster, advertising) + information on the payment or compensation MCH x x 1 x 2 x 1 x x x x x x x 3 Embryo in vitro x x x x x x x x x Prospective x x 1 x x 1 x x x x x x x x x x 4 x 4 x Device x x 1 x x 1 x x x x x x x x x x x 4 x 4 x x Observational test x x 1 x x 1 x x x x x x x x x x 4 x 4 x 4 Interventional test x x 1 x x 1 x x x x x x x x x x x 4 x 4 x x Register x x 1 x 1 x x x x x x x x x x 1 : non applicable if study is monocentric x 2 : if prospective x 3 : unless exempted x 4 : if available All documents must be provided electronically. As requested by the EC, the documents covered by the gray boxes must be provided in paper form in addition to the electronic version. Note on studies involving minors: if the EC is responsible for the opinion (single-center study or CHRAU in a multicenter study), it will be necessary to add 2 copies of: the form for requesting an opinion to the Ethics Committee, the protocol information and informed consent forms for the parents of the minor and the minor. Table 1B. Non-commercial studies

8 Page 8 / 10 Verification of the file and assignment of a unique number Each file must be submitted to the CTC Single Entry Point for verification and preliminary analysis. The purpose of this analysis is to ensure the completeness of the submitted dossier, both from the point of view of the documents required by the CTC and those required by the EC. The file will be analyzed by the CTC within 5 working days, and the PI / sponsor / contact person will be informed of the status of the application (complete or incomplete). Incomplete files are returned to the contact person to be put in order. Finally, each complete submission dossier receives a unique reference number of type: ERASME_CTC_YYYYMM_ ###. Note that this reference number is specific to the CTC and does not replace the CE reference related to your submission file. Submission to CE / Contract Management / Insurance The administrative management of submitted dossiers and their evaluation requires the EC to set the deadline for submission of applications 14 days before the evaluation meeting. In practice, for a dossier to be put on the agenda of an upcoming EC meeting, it must be submitted to the CTC no later than 5 working days before the closing date of the EC's agenda. The CTC is responsible for forwarding the complete files to the EC. The agenda of the EC can be found at : Attention: The CTC is responsible for submitting the completed dossiers to the EC. However, for reasons of legally required independence, the CTC will not analyze the content of the documents submitted to the EC. According to Article 11, 5 of the Law of 07 May, 2004 on experiments on the human person, "The ethics committee shall have a maximum of 15 days in the case of a single-center phase 1 study to communicate its reasoned opinion to the investigator and up to 28 days in the case of other experiments. Such time limits shall be reckoned from the date of receipt of the duly drawn up application, provided that the fees referred to in Article 30 have been paid. "This applies both to new clinical research s and to amendments to existing studies. For example : 14/08 15/08 16/08 17/08 18/08 Deadline for submission of a file to CTC 21/08 22/08 23/08 24/08 25/08 Closure of the Agenda for the meeting of 05/09 28/08 29/08 30/08 31/08 01/09 04/09 05/09 06/09 07/09 08/09 EC evaluation meeting

9 Page 9 / 10 The contracts will be analyzed at the budgetary (feasibility) and legal level in parallel with the submission to the EC. For studies in which Hôpital Erasme is the sponsor, an insurance policy with Ethias will be requested, and will also be carried out in parallel with the legal, budgetary, and ethical revisions. Consolidation and signature During this stage, the various approvals of the 4 entities (legal, budget, ethics, and insurance) working in parallel are collected and consolidated. The contract is then signed by the sponsor, the head of the service, the principal investigator, and the general and medical directorates. This period of consolidation and signature of contracts can take up to 10 working days. «Green light» letter As soon as the contract is signed by all parties, the "green light" authorization to start the study is sent by the CTC to the lead investigator and the EC. 4. Submission of final work (TFE) The submission of a TFE via the Single Entry Point is exclusively reserved for students and healthcare professionals who must present their research work related to human subjects (Erasme patients or healthy volunteers at Hôpital Erasme) and performed at Hôpital Erasme as part of the end of their graduate studies (masters, complementary masters, DES). As a reminder, the following s should not be submitted to the Single Entry Point: 1. Animal or in vitro research s that do not use human body material, 2. s on cadavers, 3. Literature reviews, 4. Surveys of health professionals on their practice, if these surveys do not use data from medical records or refer to individual patients 5. Case reports. The submission of a must be made before the research begins. This can only start after receiving the green light letter from the CTC. Before sending your submission to the CTC, your must have been validated by your direct referent (supervisor, scientific officer, hospital manager) and accepted by the persons (doctor in the hospital service) in charge of the patients or healthy volunteers you wish to recruit. The finalized submitted dossier must be sent electronically ( ) to the following address: Service.Rech-Biomed@erasme.ulb.ac.be Your file will include: 1. Cover . Your will include the title of your, a list of the different parts of your file that will be attached to your file (in.doc format because we are not equipped to read.odt format) and will be sent to the CTC as CC: the sponsor of the research, the person(s) in charge of the service (s) / site (s) (doctor / director) where your recruitment will be organized when necessary. 2. All of the attachments that constitute your file.

10 Page 10 / 10 Depending on the research type, the folder must contain the following documents: TFE Request for advice to the Ethics Committee (DACE) The spreadsheet containing all your research data ("Case report Form (CRF)") Informed consent document (DIC) Copy of the request sent to the persons in charge of the service where your recruitment will be organized and their answer if your EFT is based on the recruitment of patients or healthy volunteers Questionnaires or other material useful for the evaluation of the ethics committee The material (poster, letter to the participant) that may be used to recruit research participants. Prospective Project (interventional and observational) x x x x x x x Retrospective Project x x Application for insurance if the risk associated with participation in the study is considered to be significant (greater than Class III) Investigation x x x x x The semi-directive interview grid / the animation guide for a focal group 5. References 6. Appendices 7. Internal Links 8. External Links Documents :