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Declaration of Experiment in AZ Sint-Lucas Brugge

Declaration of Experiment in AZ Sint-Lucas Brugge

General information

Type of declaration

*Retrospective studies and case reports only using existing data or an existing database

Prospective study (not CTR/ MDR/ IVDR)

Prospective study (CTR/ MDR/ IVDR)

Retrospective study*

Other (For bachelor/master thesis, read more: Eindwerk - AZ Sint Lucas)

read more: Eindwerk - AZ Sint Lucas

Clinical relevance

Feasibility of the trials including suitability of the infrastructure

Financial agreement between sponsor and investigator/hospital

Yes

Details

Participation of children or patients unable to give consent

Yes

Participation of patients in emergency situations

Yes

Payment

€ 164,21 (exclusive VAT) for commercial non-interventional studies € 492,57 (exclusive VAT) for commercial interventional studies In order for the hospital to provide a correct invoice, please give the correct invoice details to the EC

Study name

Protocol number

Principal Investigator at AZ Sint Lucas Brugge

Site number

Study reference

Invoice address

VAT number

Email address

Company contact person

For the submission of your study to our local ethics comité, please send an email to ethisch.comite@stlucas.be including following documents

Protocol
Investigator's Brochure
Informed consent (Dutch)
Patient information and questionnaires
Protocol Synopsis (Dutch)
CV local investigator
CV national investigator
GCP certificates investigators
Contract
Insurance document

AZ St-Lucas specific information

Please select all AZ Sint-Lucas departments/disciplines that will be involved in the trial

Coordination of clinical trials

Nursing support

Pharmacy

Laboratory

Radiology

Pathology

Cardiology

There will be no need for support from personnel or services from AZ Sint-Lucas Brugge.

Other

for contact details, click here

If Nursing support is needed, by which department

Specify:

Processing by

External Lab

AZ Sint-Lucas Lab

Both

Pharmacy

The pharmacy needs to contacted (by telephone or e-mail) prior to the start of each trial. The questions below can serve as a help for the preparation of the contact.

Receipt of study medication and/or drug accountabillity with fax confirmation

Receipt of study medication with IVRS confirmation

Storage

Immediate transfer to department/investigator

Temperature registration

Prescription-based delivery to patient (including drug accountabillity)

Confirmation of patient delivery in IVRS

Receipt and storage of returned medication

Preparation of a sterile product

Preparation of non-sterile products

Material need for the preparation of the product

Extra medication needed for the study except for the investigational product

Destruction of medication

Conservation of code envelopes

If material is needed for the preparation of the product, specify

If extra medication is needed for the study except for the investigational product, specify

Are pregnancy tests necessary for the study, and will these be provided by the sponsor?

Yes

Will ATMP's (Advanced Therapy Medicinal Products) be used in this study?

Yes

Is there blinding necessary for this study (blinded and unblinded team)?

Yes

Please add a protocol or protocol summary detailling the study drug related aspects

Laboratory

Which laboratory tests (regardless of the funding) will be carried out for the trial (= quantity)? Please add a detailed protocol and the lab manual

Samples

Blood

Faeces

Urine

Other

If other, specify

Analyses carried out by

Central laboratory

Laboratory AZ Sint-Lucas Brugge

Analyses can be considered standard of care (charged to RIZIV)?

Yes

Both

Sampling is done

At the laboratory

At the ward

Freezing required?

Yes

If freezing is required, at which temperature (°C)

Material for sampling and sample handling provided?

Yes

The laboratory uses the Starstedt Monovette system for blood sampling. Is it possible to provide tubes of this type?

Yes

Will lab kits be provided for all visits?

Yes

If material will be provided by the sponsor, please keep in mind that the lab uses the Starstedt Movovette system for blood sampling.

Remarks

Radiology

Which investigations will be carried out for this trial (+ quantity)? Please add a detailed protocol and time schedule of the events.

Does the study protocol imply investigations that are requested specifically for the purpose of the study and consequently can not be charged to the patient/RIZIV?

Yes

Will contrast fluid be used for CT and MR scans?

Yes

Does the same equipment need to be used for CT scans or are identical parameters sufficient?

Same equipment required

Other device but calibration prior to each measurement necessary

Identical parameters are sufficient

Which measurements need to be done?

Whom has to take the measurements?

Central Reader

Radiologist

Investigator

Need for the use of markers on the images?

Yes

Need to complete specific forms of study purposes by radiologist?

Yes

If yes, please add the forms to this request

Need to burn images on CD-rom?

Yes

Need to make phantom scans (dummy run) for CT or MR sans?

Yes

Will images need to be uploaded to a central portal?

Yes

Pathological Anatomy

If yes, at which date?

Does the study protocol imply investigations that are requested specifically for the purpose of the study and consequently can not be charged to the patient/RIZIV?

Yes

Are there specific forms to be completed by the pathologist?

Yes

If yes, please add the forms to this request form

Does the protocol require slides or blocks to be shipped to other hospitals/laboratories and/or is there a requirement to store them at the pathology department?

Yes

If yes, please add the requirements for sending/storage

Shipping adress

Contact details in case of special collection service

Does the protocol require that slides/blocks are requested from other hospitals?

Yes

Is there local evaluation requested?

Yes

Is there preparation necessary before shipment?

Yes

Which task?

Formalin fixed tissue

Fresh tissue

Frozen tissue

Blanco slides

Paraffin blocks

Cardiology

Which assesments are requested?

ECG

Echo

MUGA

Will a ECG be delivered by the sponsor?

Yes

Other

Zie ook

Info voor patiënten

Bezoektijden

Wegwijs

Vacatures

AZ Sint-Lucas Brugge

Sint-Lucaslaan 29
8310 Brugge
Ondernemingsnummer 0408.116.216

info@stlucas.be
Algemeen 050 36 91 11
Spoed 050 36 91 12

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Declaration of Experiment in AZ Sint-Lucas Brugge

Declaration of Experiment in AZ Sint-Lucas Brugge

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