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 .

SUBMISSION DOCUMENTS REQUIRED ACCORDING TO THE TYPE OF STUDY

To help you determine the type of study 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, Certificate of no-fault insurance, Number of patients planned for CUSL, Initial questionnaire GDPR

INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL NON CTR) - EXTERNAL SPONSOR

Protocol, summary in French (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, CTA form, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, scientific notice if registered drug, investigator brochure if unregistered drug , any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants

INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) - CTR CUSL SPONSOR

Before preparing the submission file, contact the academic central desk and provide the following documents (available via PaCo or upon request): Clinical Trial Protocol, Statistical Analysis Plan, Study Data Management Plan, Study Monitoring Plan, Risk Management Plan, CUSL Sponsor Feasibility Assessment, DSMC Charter (if required). 
Also include project funding plan, Number of patients planned for CUSL, Initial questionnaire GDPR.
The desk officer will assist you in the preparation of the submission package after your project has been approved by the Medical Director of the Clinics.

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.
Documents required as soon as they are available:
Study protocol, Consents, Suitability of site, Conflict of interest statements by the PI and declaration by the PI for the research team, Draft contract and budget, Certificate of no-fault insurance, Number of patients expected at CUSL, Initial questionnaire GDPR
Documents required if submission type is Validation by local EC or separate FAMHP and local EC opinions:
Provide the documents according to the design of the study (interventional, non-interventional, retrospective or MCHr) and add : 
If CE label and in the indication: CE label and device manual
If no CE label: Investigator brochure and FAMHP file

INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR CUSL SPONSOR

Before preparing the submission file, contact the academic central desk and provide the following documents (available via PaCo or upon request): Protocol, Statistical Analysis Plan, Study Data Management Plan, Study Monitoring Plan, Risk Management Plan, CUSL Sponsor Feasibility Assessment, DSMC Charter (if required). Also include project funding plan, Number of patients planned for CUSL, Initial questionnaire GDPR. The desk officer will assist you in the preparation of the submission package after your project has been approved by the Medical Director of the Clinics.

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 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 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, dated and signed CV (<3 years) of the principal investigator and co-investigators, databse used

National multicentric : GDPR Information

International multicentric and/or rare disease and/or small population : GDPR Information & consent

RETROSPECTIVE STUDY

Simplified submission form, research description letter, initial questionnaire GDPR, informed consent or exemption request, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting CUSL sponsor, CRF

RESIDUAL HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA

Simplified submission form, research description letter, initial questionnaire GDPR, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting CUSL sponsor

TEMPLATES FOR SUBMISSION DOCUMENTS

Related documents

Document 1

Download

Acknowledgement of receipt

Simplified submission form

Download

Simplified submission form for master/bachelor thesis

Download

Declaration of conflict of interest form

Download

Summary of anti-corruption rules

No conflicts of interest for the research team

Download

GDPR - Initial Questionnaire

Download

Financial reporting CUSL sponsor

Download

Protocol

Clinical trial protocol

Download

Medical device protocol type

Download

Clinical interventional study protocol

Download

Non-interventional or retrospective clinical study protocol

Download

Informed consent

Information checklist for informed consent

Download

Informed consent for clinical research without medicinal product or device

Download

Informed consent for clinical trial with a medecinal product or device

Download

Informed consent for observational study

Download

Informed consent adults temporarily incapable

Download

Informed consent emergency

Download

Request for exemption to consent

Download

GDPR information for registry

Download

GDPR information & consent for registry

Download

 

 

TEMPLATES FOR ACADEMIC CONTRACTS AND ASSOCIATED DOCUMENTS

 

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:

  1. Reads the documents and then sends an email acknowledging receipt and listing the missing documents.

  2. 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).
     
  3. Pre-analyses the documents.
    In the case of a drug or medical device study, assists in requesting Medical Direction approval for the project if Cliniques Universitaires Saint-Luc is the sponsor of the study. Sends the sponsor the documents to prepare the submission file when the direction's approval is obtained.

  4. Sends drafts contract to the contracts and finance unit as part of a multi-centre study.

  5. Submits any internal agreements to the contracts and finance unit.

  6. Fills in the insurance application if the Cliniques universitaires Saint-Luc is the sponsor of the study.

  7. Requests regulatory approval from the quality and regulatory coordinator.

  8. Requests financial approval from the head of the contracts and finance unit for monocentric studies.
     
  9. 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: July 2022