Request a study
Confidentiality & Feasibility
A Confidential Disclosure Agreement (CDA), is an agreement between at least two parties. This agreement contains information about a possible new study that cannot or may not yet be shared. It is concluded when the parties are considering working together and want to gain insight into each other's processes and/or methods.
Feasibility is an essential first step in the clinical study process. It involves assessing whether a study is practically feasible within UZA. During this phase, a thorough assessment is made of whether the necessary resources, expertise, infrastructure, and patient population are available to successfully conduct the study.
This is often done via a questionnaire that the client sends to the department by email. Once a feasibility questionnaire has been completed for a study, it must also be registered in the UZA's Clinical Trial Management System (CTMS) via Requests > Add new > Feasibility. Once the corresponding study has been registered in the CTMS, the feasibility form can be linked to the study via the Relations tab. More information about registering studies in the CTMS and obtaining access can be found below under Administrative start-up.
Administrative start-up
If you want to start a clinical trial at UZA, there is one central point of contact: the Clinical Trial Center (CTC). The CTC coordinates clinical trials, offers advice, and provides training (such as GCP e-learning) to ensure the success of your trial.
All clinical trials that meet at least one of the following criteria must be registered in UZA's Clinical Trial Management System (CTMS):
- patients are recruited for the trial at the UZA.
- data from UZA patients is used in the trial.
- body material from UZA patients is used in the trial.
If a study does not meet any of the criteria, you do not need to submit the study to the CTC and you should contact all relevant departments yourself (if applicable):
If a study does meet one of these criteria, it must be reported to the CTC.
Below you will find more information about the various stages of the reporting process:
- 1
Phase 1: CTMS
The Clinical Trial Management System (CTMS) at UZA centralizes all studies and collects the information in one place. It facilitates the administrative follow-up of clinical studies and promotes smooth collaboration with other organizations.
To register a new study in the CTMS, you must first request access to the CTMS by visiting the web application .
How do I request access to the CTMS?
For UZA staff:
- Go to the web application.
- Select ‘I have an UZA account’.
- You will be automatically logged in with your UZA login details.
- Upload a valid version of your CV and ICH-GCP certificate to gain access to the portal.
For external users:
- Go to the web application.
- Select ‘I want to request access’
- Provide the following information: first name, last name, email address, phone number, organization, and select ‘Request access’.
- Your request will be reviewed by the CTC. Once the request has been approved, you will receive a confirmation email with login details.
- Go back to the web application.
- Select 'I do not have an UZA account'
- Log in with your login details.
- Upload a valid version of your CV and ICH-GCP certificate to gain access to the portal.
How do I register my study in the CTMS?
Once you have access to the CTMS, you can register a new study by navigating to Requests and selecting Add new. For a new study, select Initial template.
After you have entered all the necessary information, navigate to the General tab and click on Request approval. In order to start the study, it must first be approved in the CTMS by the Principle Investigator (PI). Once the request has been approved by the PI, it will be reviewed by the CTC. The CTC will complete the registration in the CTMS and aims to give you approval for the created projects within 24 hours. Once an application has been approved by the CTC, the CTMS number (Study number) for the study will automatically appear. This number always consists of 6 digits (for example: 003520).
More information about the registration of new studies can be found in the manual .
Problems requesting access and/or registering a study? Ask your questions directly in the CTMS via the Questions tab or send an email to pergapedia@uza.be.
Once the study has been registered in the CTMS, several essential documents must be uploaded. All of these documents must be present (in multiple languages, if applicable), otherwise the workflows will not be started. Note: not all documents are required for certain types of studies (e.g., a retrospective study does not require an informed consent form).
- Protocol - A document, drawn up by the principal investigator or sponsor, that describes the study. This document contains the background of the study, the context, the purpose, the methods that will be used, the steps that need to be taken, etc.
- Informed Consent Form (ICF) in all languages used (if applicable) - A document for the participant with information about the study (such as background, purpose, benefits, risks, rights, obligations, etc.). By signing this document, the participant gives his or her consent to participate in the study.
- Electronic Case Report Form (eCRF) - An online software application that collects, organizes, and transfers data about the study, such as REDCap or Castor. Please note: the UZA does not accept Word/Excel as a valid eCRF.
- Draft contract (if applicable) - An initial, unedited version of the contract between the UZA (research site) and the sponsor or CRO. We recommend using the template provided by pharma.be (negotiated and agreed upon by all Belgian university hospitals) to speed up the processing of your file.
- 2
Phase 2: Start-up workflows
After registering the study in the CTMS, five potential workflows must be started up:
- Financial flow
- Ethics Committee flow
- Legal flow
- Biobank flow
- DPO flow
To ensure that these are started up correctly, it is important that all ‘Control Panel Departments’ are selected when registering a new study. You can find this in the CTMS under the tab Request > Parties involved > Involved departments.
Financial flow
This flow is handled directly with the departments involved. Please contact them for more information.
- The sponsor (or CRO) emails the budget proposal to all departments involved.
- The departments involved negotiate the budget proposal with the sponsor or CRO.
- The departments involved email their approval of the agreed (partial) budgets to the sponsor or CRO.
- Once all (partial) budgets have been approved, the sponsor/CRO/study team uploads all approvals for the partial budgets, including the agreed prices per performance, to the CTMS. Afterwards, a final budget review is carried out by the CTC. The status of this can be viewed in the CTMS by selecting your study and navigating to Supporting departments.
Ethics Committee
This flow runs parallel to the submission to the CTC.
Where you need to submit a study depends on the legislation that applies to your research:
- Clinical Trial Regulation (CTR) --> Clinical Trial Information System (CTIS)
- Medical Device Regulation (MDR) --> Common European Submission Portal (CESP)
- Experiments Act --> Central/local Ethics Committee
Submitting a study to the UZA-UA Ethics Committee is done as follows:
- The sponsor, principle investigator, or UZA representative completes the digital application via the platform https://application.ecuzaua.be.
- The EC declares the submitted file admissible to the principle investigator.
- The EC discusses the study file during its weekly meeting.
- The EC sends any comments or questions to the principle investigator.
- The principal investigator responds to these questions/comments.
- The EC sends the final EC approval to the principle investigator.
More info: UZA/UA Ethics Committee
Legal flow
This flow is centrally managed by CTC.
- The draft agreement/draft amendment and the protocol are uploaded to the CTMS by the study team/CRO/client.
- The study is assigned to a lawyer at the UZA. The designated lawyer negotiates the legal text of the agreement/amendment with the study client, any CRO(s), and the department(s) involved. The status of this can be viewed in the CTMS by selecting the study and navigating to Supporting departments. Please note: there is no point in sending these documents directly to the legal department as they will not be reviewed.
- The legal department emails the agreement on the legal text of the contract (including GDPR) to the client, the principal investigator, and the UZA representative.
Please note: for contract amendments, an amendment must be registered in the CTMS via Requests > Add new > Amendment. In the Application amendment tab, under Info amendment, you can indicate that it concerns e.g. a ‘Change in the contract’ or ‘Change in the budget’.
DPO flow
- After completing the study registration in the CTMS and uploading the essential study documents, the CTC UZA reviews the admissibility of the documents. These are then forwarded to the Data Protection Officer (DPO) or DPO representative of the UZA.
- The DPO validates the entire file based on the information entered in the CTMS under the GDPR tab and checks that all GDPR requirements have been met in the documents submitted. The status of this can be viewed in the CTMS by selecting the study and navigating to Supporting departments.
- Once the DPO has given their approval, this information is forwarded to the legal department for the final contract to be drawn up.
Biobank flow
- The study team/CRO/client uploads the protocol to the CTMS.
- Biobank Antwerp assesses whether involvement in the study is necessary. The status of this can be viewed in the CTMS by selecting the study and navigating to Supporting departments.
- If involvement of the Biobank is required (this is the case for studies involving samples), they will contact you. If this is not the case, they will not contact you.
- After approval, the Biobank will forward the agreed budget to the CTC (ctc@uza.be).
- 3
Phase 3: Completion
- The legal department has approved the contract.
- The DPO has approved the GDPR form and the essential documents.
- Following the final budget review, the CTC has approved the budgets included in the contract.
Please note! The signing process can only begin once the CTC has given its final approval.
The sponsor initiates the signing process. The UZA requests that the following order of signing be respected:
- sponsor/CRO
- principal investigator
- all departments involved
- CEO of the UZA
We prefer to use DocuSign for signing documents, but we also accept handwritten signatures.
Please send a fully signed copy to the following parties:
- principal investigator
- CTC
- legal department
- Biobank Antwerp
Practical start-up
Once the contract has been signed and the study has been approved by the ethics committee, a number of practical matters still need to be arranged before the study can actually start. These include planning a SIV (Site Initiation Visit) and preparing the (e)TMF ((electronic) Trial Master File) and (e)ISF ((electronic) Investigator Site File).
Site Initiation Visit
Before a study can begin, a Site Initiation Visit (SIV) takes place. During this meeting, the research center is prepared for the study. Various aspects are discussed, such as the protocol, the responsibilities of the research team, the use of study materials, procedures, and the rules surrounding safety and data management. The SIV is usually organized by the study sponsor or a Clinical Research Associate (CRA) and attended by the principal investigator and any study coordinator.
An SIV can only take place once the contract has been fully signed and ethical approval has been granted.
If the pharmacy is also involved in the study, an SIV must also be held there: more infoTMF/ISF
Both a (e)TMF ((electronic) Trial Master File) and (e)ISF ((electronic) Investigator Site File) are mandatory for clinical trials. These documents are important for complying with the rules and guidelines for good clinical practice.
- (e) TMF is the central collection of all important documents that the sponsor of a clinical trial must keep. The (e) TMF contains all documents that demonstrate that the trial was conducted in accordance with Good Clinical Practice (GCP) guidelines and applicable legislation.
- The(e) ISF is a collection of important documents kept by the research team at the trial site. The (e) ISF contains, for example, letters of approval from ethics committees, consent forms from participants, the study protocol, and other study-related documents. The ISF is required for each study site to ensure the integrity of the study and the safety of the participants.
Both the (e) TMF and the (e) ISF can be stored physically or electronically. If the UZA is the sponsor, we prefer electronic binders for more efficient and secure storage and access to documents. This helps to streamline processes. For more information about this, please contact CTC UZA.
If another client wishes to use an electronic platform, the UZA will allow this, provided it has been checked by the legal department and the Data Protection Officer (DPO).
Access to EPD
If a monitor, auditor, or inspector wishes to access the UZA's electronic patient record (EPD), the procedure below must be followed. The processing time for this procedure is at least fourteen days. So make sure you submit your request on time.
The monitor, auditor, or inspector will receive a read-only account and will only have access to the files of patients included in the study for which the monitoring or audit is taking place.
- Registration at UZA
The CRA completes the electronic registration document via this link: https://www.uza.be/aanmeldingsdocument.
In the ‘Field of study/function’ drop-down menu, select ‘Clinical research assistant’.
The UZA personnel department will register the external employee. - Requesting access to the UZA patient file for monitors
The researcher or member of the research team must submit an ICT serviceSD+ request containing the following information: First and last name of the monitor and read-only access for the CRA to the EPD. - Request for access to study within patient file
The monitor sends an email to MonitorLoginEPD@uza.be to request access to the e-learning, with the following information: first and last name of the monitor and email address.
The monitor will then receive an email with the link to the e-learning, along with a login and password.
After the training, the monitor sends an email to MonitorLoginEPD@uza.be with the following information: EPD training completed on date, together with the monitor's first and last name.
Details of the study for which access is required: CTMS number, department, principal investigator at UZA.
Once the monitor has completed the training, an email will be sent confirming that the monitor has been granted access to the requested studies.
- Registration at UZA
Support and advice during the study
In addition to general support, the Clinical Trial Center (CTC) also offers specialized guidance in specific areas such as data management, statistical analysis, and monitoring of clinical studies. The CTC also supports other academic and spin-off companies from academic organizations as an academic Clinical Research Organization (CRO).
Contact
Clinical Trial Center (CTC)
FAQ
Where can I find answers to questions about submitting a proposal to the UZA/UA Ethics Committee?
For this, it is best to contact the UZA/UA Ethics Committee directly: EthischComite@uza.be
I am a master's student at the University of Antwerp. Do I also need to register my studies with the CTC UZA?
If the UZA is involved in your studies and your studies meet one of the above conditions, you must also register your master's thesis with the CTC UZA.
Can I submit my study to the CTC before I have received ethical approval?
Yes, you can. Both processes can run in parallel.
Please note: if you need to submit an application to the UZA/UA Ethics Committee, you will need a CTMS number to do so. In that case, you will first need to request a CTMS number. The workflows can then be started before you have received approval from the UZA/UA Ethics Committee.
Can an SIV proceed if the contract has not yet been signed?
No. An SIV (Site Initiation Visit) can only proceed if the study has been approved by the ethics committee and the contract has been signed by all parties.