Academic study
The central academic desk is the only access point to the ethics committee (CEHF) for academic studies (CUSL or external promoter). It is also the contact point for promoters, investigators and research coordinators for the initial submission of academic studies.
CONTACT DETAILS
The central academic desk can be reached at : guichetacademique@saintluc.uclouvain.be and 02/764.17.44 .
Organisation Management Service (OMS) registration number : Cliniques Universitaires Saint-Luc - ORG-100008950 - LOC-100014498
SUBMISSION DOCUMENTS REQUIRED ACCORDING TO THE TYPE OF STUDY
To help you determine the type of study, the applicable legislation and the type of submission for your project, consult the clinical study flowchart.
TYPE OF STUDY | DOCUMENTS TO BE PROVIDED |
| INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) - CTR EXTERNAL SPONSOR | Contact the academic central desk for non-commercial clinical trials conducted at Cliniques Universitaires Saint-Luc. Documents required as soon as they are available: Study protocol, Informed consents, Suitability of site, Conflict of interest statements for the PI and PI statement for the research team, Draft contract and budget, Financial reporting academic sponsor (completed by PI), Certificate of no-fault insurance, Number of patients planned for CUSL, Initial questionnaire GDPR |
| INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) - CTR CUSL SPONSOR | Contact the academic central desk and provide the following documents: Clinical Trial Protocol, Financial Reporting CUSL Sponsor, Drug Supply Arrangements, Planned Number of Patients (site breakdown), Initial RGPD Questionnaire. The academic desk officer will help you to prepare the submission package after assessing the feasibility of your project. |
| INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR EXTERNAL SPONSOR | - Flowchart to be consulted to determine the type of device and submission Contact the academic central desk for non-commercial clinical investigations conducted at Cliniques Universitaires Saint-Luc. |
| INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR CUSL SPONSOR | Contact the academic central desk and provide the following documents: Clinical Trial Protocol, Financial Reporting CUSL Sponsor, Device Supply Arrangements, Planned Number of Patients (site breakdown), Initial RGPD Questionnaire. The academic desk officer will help you to determine the submission type required and to prepare the submission package after assessing the feasibility of your project. |
| OTHER INTERVENTIONAL STUDY | Protocol, summary in French (1 page), document 1, initial questionnaire GDPR, informed consent, declaration of insurance form (done by CTC), certificate of insurance if external promoter, draft contract and budget, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, financial reporting academic sponsor (completed by PI) or CUSL sponsor, CRF, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants |
| NON-INTERVENTIONAL STUDY | Protocol, summary in French (1 page), document 1, initial questionnaire GDPR, informed consent, declaration of insurance form (done by CTC), certificate of insurance if external promoter, draft contract and budget, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, financial reporting academic sponsor (completed by PI) or CUSL sponsor, CRF, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants |
| REGISTRY | Protocol, Simplified submission form, Initial questionnaire GDPR, draft contract DTA, financial reporting academic sponsor or CUSL sponsor, dated and signed CV (<3 years) of the principal investigator and co-investigators, databse used In the context of a registry, patients must be informed of the use of their medical data. In the case of an ERN-type European Registry, an RGPD Information and Consent document is required. |
| RETROSPECTIVE STUDY | Simplified submission form, protocol, initial questionnaire GDPR, draft contract and budget, financial reporting academic sponsor (completed by PI) or CUSL sponsor, dated and signed CV (<3 years) of the principal investigator and co-investigators, CRF In the context of a retrospective study, patients must be informed of the use of their medical data. |
| RESIDUAL HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA | Simplified submission form, research description letter, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting academic sponsor (completed by PI) or CUSL sponsor |
TEMPLATES FOR SUBMISSION DOCUMENTS
TEMPLATES FOR ACADEMIC CONTRACTS AND ASSOCIATED DOCUMENTS
- Template of academic contract validated by academic hospitals
- Template of academic contract for non drug trials validated by academic hospitals
- CUSL/UCL Clinical Study Contract
- Material Transfer Agreement
- Material Transfer Agreement CUSL/UCL
- Data Transfer Agreement
- CUSL/UCL service provision contract
- SIP Facility Profile Form.
- Electronic System Validation
- Computer system compliance with FDA21CFR Part 11
INITIAL SUBMISSION PROCEDURE
Once the sponsor or principal investigator has at least a research protocol, an informed consent document and a budget evaluation, they send an email to the central academic desk (guichetacademique@saintluc.uclouvain.be) with the documents listed as attachments.
The central academic desk:
- Reads the documents and then sends an email acknowledging receipt and listing the missing documents.
- Creates the study in the Claire software so that the Cliniques universitaires Saint-Luc investigator can monitor the progress of the file via tracking indicators (date of first contact, date of receipt of documents, date of regulatory pre-analysis, date of regulatory approval, date of financial approval, date of insurance request, date of request for DPO or legal opinion, date of receipt of all documents finalized for submission to CEHF).
- Performs a pre-analysis of the documents and assesses the regulatory and financial feasibility of the project. In the case of a drug or medical device study, assists the CUSL investigator-sponsor to prepare the submission file
- Sends drafts contract to the contracts and finance unit as part of a multi-centre study.
- Submits any internal agreements to the contracts and finance unit.
- Fills in the insurance application if the Cliniques universitaires Saint-Luc is the sponsor of the study
- Requests financial approval from the head of the contracts and finance unit for monocentric studies.
- Submits the file to the ethics committee once it is complete and in order from a regulatory/financial point of view. Makes the submission to the competent authorities for studies involving a drug or medical device.
In the case of a study involving a drug or a medical device for which Cliniques universitaires Saint-Luc is the sponsor, the central academic desk is responsible for submitting modifications and amendments to the competent authorities, as well as for the follow-up of the clinical research: annual report (ASR), SUSAR, deviations, violations, unexpected events, SAE with death, and end-of-study notifications.
For other types of studies, the academic central desk only handles initial study submissions. The research team is responsible for the submission of modifications and amendments to the hospital-faculty ethics committee as well as for the follow-up of clinical research: annual reports for interventional studies, deviations, violations, unexpected events, SAE with death, notifications of the end of the study. The documents related to the follow-up of the research are available on the website of the hospital-faculty ethics committee via this link (https://www.saintluc.be/en/ethics-committee-Clinical-investigations)
TRIAL MASTER FILE
If the Cliniques universitaires Saint-Luc is the sponsor of the study, a Trial Master File template is sent to the principal investigator, so that they have a set of study documents in order at the regulatory level.
ENTERING THE STUDY IN CLINICALTRIALS.GOV
When the the Cliniques universitaires Saint-Luc promote an intervention study,the central academic desk also offers help to record the study on the clinicaltrials.gov website. . Indeed, any prospective intervention study must be available to the public. A record in a public database is also required for any subsequent publication.
Update: August 2024
