User guide PDF User guide for registering a study PDF - 378.16 Kb PDF Decision tree for clinical investigation qualification according to the MDR PDF - 286.69 Kb Applicant details Name Please note that the applicant will also be registered as the principal investigator in case of a case report. E-mail address Types of studies Indicate the type of study Prospective study: clinical trial with medication (CTR), clinical investigation with medical device (MDR), performance study (IVDR) or experiment Retrospective study (= reuse of existing data only) Human body material (HBM) - Secondary use only Human body material (HBM) - Artificialised/extracted without application in man Human body material (HBM) - Transfer as part of service/analysis by UZ/KU Leuven (fee for service) Human body material (HBM) - Derived from body donated to science by testament Case report Master's thesis in Biomedical Sciences with external organisation (which was referred by the OBC, the Education-Support Committee) Experiment/clinical research outside UZ/KU Leuven for approval by fully accredited EC Voluntary submission of projects to EC (study not covered by Experiments Act, biobank legislation, CTR, MDR or IVDR) Prospective study Choose your type of prospective study Experiment Clinical trial (CTR) Clinical research with medical device (MDR) Performance study (IVDR) Has the UZ Leuven researcher been appointed as national coordinator? No Yes This is only possible in multicentre studies. Which tasks are delegated? (e.g. academic studies: monitoring, safety reporting; commercial studies: assistance with national legislation, ethics committee submission...) Who will be responsible for taking out study insurance in accordance with Belgian regulatory requirements? Sponsor Other Specify Is involvement of UZ Leuven supporting departments needed to execute the study? No Yes Specify which service you want to use? Pharmacy medication Pharmacy GMOs Pharmacy medical supplies Imaging: nuclear medicine PET-CT, bone scan Imaging: radiology Biobank Clinical pharmacology centre (phase 1 unit) Please contact them on +32 16 34 20 20. CTC Data management (construction eCRF,...) CTC Monitoring CTC Safety Forensic medicine/mortuary Function measurements in adult cardiovascular patients Function measurements in child cardiovascular patients Function measurements in pneumology IT Human heredity centre (Centrum menselijke erfelijkheid) laboratory Lab medicine laboratory Pathological dissection laboratory Prevention and environment - Radioactive substances/source: therapy or calibration/dosimetry Prevention and environment - X-ray equipment outside standard clinical protocol Prevention and environment - Pathogenic organisms Prevention and environment - CAR-T cells Prevention and environment - Dexa scan Dermatology Gynaecology Ophthalmology ORL-H&N (NKO-GH) Neurology Other service Register a clinical study Clinical trial (CTR) Eu-CT number Trial Medicine Medicine containing genetically modified organisms Medicine in combination with a device Medicine in combination with an IVD Which device and which submission flow? Which IVD and which submission flow? Phase Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 Phase 4 Will the human body material (HBM) collected in this clinical trial be used only for future scientific research into the same disease, treatment or medicine being investigated in the current clinical trial? Yes NO biobank approval required: do not tick the biobank as a support service. No DOES require biobank approval: tick biobank as supporting service. Study with in vitro medical device (= performance study) under IVDR Workflow View the complete workflow (pdf). Study out of scope of IVDR follows the flow of an experiment or HBM. Type With CE marking Without CE marking Academic or commercial Commercial study Academic study Type of commercial performance study with in vitro medical device Post-Market Clinical Follow-up study with additional burdensome or invasive procedures Flow 5: Validation of the FAMHP (FAGG) validation and opinion of the EC 2017 Clinical performance studies with surgically invasive sampling for performance study purposes only Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical interventional performance study (where results may affect patient care) Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical performance study with additional invasive procedures or other risks to subjects Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical performance study with companion diagnostics on prospectively collected samples Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Type of academic performance study with in vitro medical device Clinical performance studies with surgically invasive sampling for performance study purposes only Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical interventional performance study (where results may affect patient care) Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical performance study with additional invasive procedures or other risks to subjects Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 Clinical performance study with companion diagnostics on prospectively collected samples Flow 6: Consolidated opinion of the FAMHP (FAGG) and EC 2017 With in vitro medical device Delivered free of charge by company Purchased by the service Standard of Care (SOC) and billing through NIHDI (RIZIV)/patient Retrospective study Time period for data collection for retrospective analysis Start date of data collection End date of data collection? Initiator/commissioner UZ Leuven/KU Leuven Commercial Other academic initiator/commissioner (including VIB) UZ/KU Leuven sends data to a third party + to which party (if other than initiator/commissioner)? UZ Leuven/KU Leuven is the initiator/commissioner Only UZ/KU Leuven data is used without third-party involvement UZ/KU Leuven data is used and UZ/KU Leuven receives data from a third party UZ/KU Leuven data is used and UZ/KU Leuven sends data to a third party UZ Leuven/KU Leuven only receives third-party data Specify the third party Clinical research with medical device (MDR) Workflow View the complete workflow. Type With CE marking Without CE marking Clinical research with medical device (MDR) With CE marking (Academic or commercial) clinical research with CE-marked device used outside the intended purpose (off-label use) Flow 1: Consolidated opinion of the FAMHP (FAGG) and EC 2017 (Commercial) Post-Market Clinical Follow-up studies with additional burdensome or invasive procedures Flow 2: Validation of the FAMHP (FAGG) and opinion of the EC 2017 (Commercial) Post-Market Clinical Follow-up study without additional burdensome or invasive procedures Flow 3: Only EC 2004 (Experiments Act) (Academic) clinical research with CE-marked device for the intended purpose Flow 3: Only EC 2004 (Royal Decree Clinical Research) Clinical research with medical device (MDR) Without CE marking (Academic or commercial) clinical research with device without CE marking that is not a custom-made or in-house device Flow 1: Consolidated opinion of the FAMHP (FAGG) and EC 2017 (Academic or commercial) clinical research using a custom-made device with conformity assessment purpose Flow 1: Consolidated opinion of the FAMHP (FAGG) and EC 2017 (Academic or commercial) clinical investigation with a custom-made device without conformity assessment purpose Flow 4: Separate opinion of both the FAMHP (FAGG) and EC 2017 (Academic) clinical research with an in-house tool Flow 4: Separate opinion of both the FAMHP (FAGG) and EC 2017 With medical device Delivered free of charge by company Purchased by the service Standard of Care (SOC) and billing through NIHDI (RIZIV)/patient Procurement contracts As part of the study, will UZ Leuven or KU Leuven enter into one or more procurement contracts for the purchase of goods and/or services for use in the study? UZ Leuven KU Leuven Gelieve tijdig uw financiële antenne te contacteren voor de te volgen aankoopprocedure. None of the above In the context of this procurement of goods and/or services, will the supplier of the goods and/or services process personal data of study participants? Yes No Upload the relevant documents for the procurement by UZ Leuven of goods and/or services for use in the study (such as a contract proposal or quotation) You can upload only 1 file per section. Do you have several files per section? Then bundle them in 1 compressed folder (zip file). Choose a file Human body material derived from body donated to science by testament What external support will you receive? No support Financial support Free services Other external support Describe this form of external support Choose your financial support Grant firm Grant from another institution Stichting Tegen Kanker (Foundation Against Cancer), King Baudouin Foundation, ... In the context of an EU project In the context of a TBM project In the context of a Vlaio project UZ Leuven academic research fund Internal KU Leuven funding KCE funding Other funding Specify Partner Proposed amount (incl. overheads) Secondary use of human body material Use of companion diagnostics under IVDR? No Yes: IVDR Flow 7: FAMHP (FAGG) Notification The use of HBM in this project stems from: Living donors Deceased donors Type of HBM Available (leftover) material already collected as part of a study Available (residual) material already collected in connection with diagnostics/therapy Externally obtained HBM Removal of body material from a deceased donor In case of removal of body material from a deceased donor: with or without Information and Consent Form (ICF) With prior Information and Consent Form (ICF) Organ or tissue donor without prior ICF Removal during diagnostic autopsy without ICF Enter the S number of the study Please enter the correct S number. Start with S and enter the 5 digits. e.g. S12345. Sample use Samples Pseudonymised Samples will be pseudonymised by default. The PI bears responsibility for pseudonymisation (key to identification). Anonymous Justify the reason for anonymisation if consent has not been given via Information and Consent Form (ICF) The study makes use of: UZ Leuven/KU Leuven samples only UZ Leuven/KU Leuven samples and data Third-party samples only Third-party samples and data Specify the third party(ies) from which samples/data are received Will be sent to a third party outside UZ/KU Leuven UZ Leuven / KU Leuven Data Only results from analysis/analyses bij UZ Leuven / KU Leuven UZ Leuven / KU Leuven samples without additional clinical data UZ Leuven / KU Leuven samples with additional clinical data Not applicable Specify the third party(ies) to which samples/data will be sent Limited to the use of artificialised/extracted human bodily material without application in man Does the study only use artificialised/extracted HBM, and do you confirm that it will never be used for genetic research, nor for application in man? Yes No Study must be notified under type of study 'Human body material (HBM) - Secondary use only' Master's thesis in Biomedical Sciences with external organisation With which external organisation is there collaboration? Protocol Title Protocol number Acronym Version number Application National or international National - monocentric National - multicentric International - monocentric within Belgium International - multicentric within Belgium The UZ/KU Leuven EC research is: Central EC Local EC Local EC with the addition of UZ Leuven via amendment UZ Leuven is added to the ongoing study via amendment. Which EC is central EC? UZ Leuven supporting services Is involvement of UZ Leuven supporting departments needed to execute the study? No Yes Specify which services you want to use Centre for human genetics Laboratory medicine Pathology Other service at UZ Leuven Specify Biobank Will you make use of the central storage facility storage of the biobank in this study? Yes No Nature of the study Academic or commercial Commercial study Academic study Is there financial or other support No Yes Choose your financial support Financial support from a company Financial support from another institution Stichting Tegen Kanker (Foundation Against Cancer), King Baudouin Foundation, ... Free services Free provision of equipment In the context of an EU project In the context of a TBM project In the context of a Vlaio project UZ Leuven academic research fund Internal KU Leuven funding KCE funding Other funding Specify Are other centres involved? No Yes This is only possible in multicentre studies. Confirmed: centre name and contact person e-mail address Confirmed: centre name and contact person e-mail address Confirmed: centre name and contact person e-mail address Interested: centre name and contact person e-mail address Interested: centre name and contact person e-mail address Interested: centre name and contact person e-mail address Is there a financial flow between the centres involved? Yes No About the study When is this study likely to end? Type of study participants Underage healthy volunteers Willing adult healthy volunteers Minors Willing adults Incapacitated adults, not in an emergency situation Incapacitated adults, in an emergency situation Total number of expected study participants Total number of expected UZ Leuven/KU Leuven study participants Principal investigator/promotor First name Surname E-mail address Sub-investigator Name and e-mail address Name and e-mail address Name and e-mail address Study assistant/student Name and e-mail address Name and e-mail address Name and e-mail address Sponsor/initiator Name General contact details Contact person - general E-mail address Financial contact details Contact person - financial E-mail address Contractual contact details Contact person - contract E-mail address Company number CRO (if applicable) Name CRO general contact details Contact person - general E-mail address CRO financial contact details Contact person - financial E-mail address CRO contractual contact details Contact person - contract E-mail address Contact legal department Has there already been contact with (and/or contract negotiations ongoing through) a legal department? No UZ Leuven KU Leuven/LRD KU Leuven/DOC Specify name Attachments You can upload only 1 file per section. Do you have several files per section? Then bundle them in 1 compressed folder (zip file). The contract and budget proposal must be submitted in an editable format (in a non-protected Word and Excel version respectively) Cover letter from the principal investigator Select file Choose a file Protocol Select file Choose a file Protocol - Dutch-language summary Select file Choose a file Proof of no-fault insurance Select file Choose a file Contract (proposal) Select file Choose a file Budget (proposal)? Select file Choose a file Information and Consent Form (ICF) Select file Choose a file Internship contract with external organisation Select file Choose a file KU Leuven agreement with external organisation Select file Choose a file Local ECs - Info and proof of simultaneous submission Select file Choose a file CV of the principal investigator/promotor Select file Choose a file Certificate of Good Clinical Practice (GCP) Select file Choose a file GDPR statement/questionnaire Select file Choose a file Recruitment - Equipment and recruitment method Select file Choose a file Invoicing details Select file Choose a file Template for research Select file Choose a file With artificialised and extracted material when they are not used for genetic research. Miscellaneous Select file Choose a file Written statement Select file Choose a file Comments e.g. follow-up study of..., CTC office meeting date.... Last edit: 4 March 2024