If you submit your application via the address email@example.com, the secretariat, where necessary after consulting the committee chairs, will ensure that your application arrives at the right destination. For applications to the CRC, however, more preparatory steps are required (steps 1 and 2 below) than for applications to the Biobank and Data Access Committee. This is because clinical research studies submitted to the CRC involve the recruitment of prospective subjects (patients), for example, while the Biobank and Data Access Committee deals with the release of data and human tissue samples. For applications to the Biobank and Data Access Committee, therefore, you can proceed directly to step 3.
The submission procedure to the CRC may seem like a complex and time-consuming process; however, it is sometimes possible to have various steps run in parallel (in consultation with the Trial and Data Center (TDC)). The process also ensures that you don't end up with a study that has to be stopped prematurely due to insufficient priority, poor design, unfeasible budget etc. Your own commitment as researcher to successfully go through this process is also vital.
It is important to make a distinction between care evaluation research (conducted to improve the quality of care in the Princess Máxima Center but not intended as a basis for a scientific publication) and scientific research (where a scientific publication is the goal). The flow chart below concerns the preparatory process for scientific research and not for care evaluation research. The latter can be registered directly with the Scientific Committee as specified in step 3.
All research, therefore, must ultimately be registered with and approved by the Scientific Committee. This enables an overview to be maintained of all the research being conducted in the Princess Máxima Center (and of patient burden).
1. Study design (draft synopsis) for studies in which prospective subjects (patients) are to be included
You have an idea for a scientific study in the Princess Máxima Center. You develop your idea into a draft research proposal, which first has to be discussed with and approved by various parties:
The unit heads have a research program in which they indicate where the focus lies for research within their unit for the years ahead. It is therefore necessary to liaise with the unit head (or heads, where the study involves multiple units), to determine whether your study fits within their research program(s). Where necessary, the unit head(s) will discuss your draft proposal with the chairs of the relevant SKION protocol and/or disease committees.
Prospective researchers in the Princess Máxima Center must discuss their proposed study with a (co/junior) PI in the Princess Máxima Center relevant to the proposed research, unless the study does not fall within the scope of these programs (e.g. SKION phase 3 studies, which fall under the relevant SKION disease and protocol committees). This can also mean discussion with preclinical PIs if one of the research laboratories is to be involved in the study, for example for pharmacodynamic or genetic research.
Once the draft proposal has been approved by the unit head(s) and/or PI(s), the study design can be further detailed. For an overview of who you need to involve in your study: also see annex 1.
2. Detailing the study design
For tips on preparing a clinical study in the Máxima please take a look at this document.
a) Trial and Data Center (TDC)
The Trial and Data Center (TDC) can, among others, provide statistical help and advice about the design of your study, but can also, where necessary, take care of local or central data management, trial management and the provision of research nurses. Central Datamanagement has developed a checklist of all the activities they can provide with regards to the development of a study database and maintenance of study data. In principle, all studies are monitored (including those not subject to the Medical Research (Human Subjects) Act) for quality assurance purposes. This monitoring takes place via Julius Clinical due to the necessary impartiality. The intensity of the monitoring depends on the nature of the study and the associated risks. You will also make arrangements with the TDC regarding other aspects of your study, such as single/multicenter study, protocol, study medication/pharmacy, central laboratories, contracts, finances/budget, CRF, PILs, submission of the application etc.
For the submission of your grant application, you will also make financial arrangements regarding the use and funding of TDC staff, pharmacy, central laboratories, monitoring etc.
To make an appointment for an intake meeting with the TDC please e-mail: firstname.lastname@example.org. The TDC will then compile a report of the intake meeting, with details of the arrangements made.
When you make the appointment, please specify which researchers from your study team are required to be present at the appointment.
b) LATER Trial Bureau
To make an appointment with the LATER Trial Bureau please e-mail: email@example.com.
3. Registering your application with the Scientific Committee
a) Submission of an application to the Clinical Research Committee
The Clinical Research Committee is an independent committee which is responsible for the scientific evaluation and quality assurance of all proposals for scientific clinical research. The committee assesses, among others, the protocol, the burden for the patient, the plan for funding the study, whether the study is aligned with the mission statement of the Princess Máxima Center, the tasks to be handled by the Trial and Data Centre, and finally the priority (in case of limited resources) for implementing the study. See also the document: ‘Rules of Procedure of the Clinical Research Committee Princess Máxima Center for Pediatric Oncology’, in which the procedure is described.
The following documentation should be included with your application:
- The intake form for the TDC-CRC, which can be downloaded here.
- A statement of confirmation from the unit head(s) and relevant PI(s) that they support your research
- The most recent version of the protocol.
- The funding plan for the study (including arrangements made with the TDC, pharmacy etc.).
Once the Clinical Research Committee has approved the study you can submit the study for funding and via the TDC for medical ethical review.
b) Submission of an application to the Biobank and Data Access Committee
The Biobank and Data Access Committee is an independent committee which is responsible for the evaluation of research applications where material and/or data is requested from the Princess Máxima Center biobank. The exact conditions and assessment criteria of a biobank request can be found in the ‘Rules of Procedure of the Biobank and Data Access Committee’ . The Biobank and Data Access Committee meets once every two weeks.
Relevant documents can be found here.
4. Grant application
A grant application can be submitted after the study has been approved by the Scientific Committee. This application should include any financial arrangements that have already been made with the TDC/LATER Trial Bureau.
With the grant application, (substantial) amendments can sometimes be made to the protocol on the basis of comments from external reviewers. If this is the case please inform the CRC, and also the TDC/LATER Trial Bureau if the amendments have consequences for the deployment of staff etc.
If contracts need to be concluded for your grant, you must coordinate this with the clinical trial lawyer and the approved budget can be discussed with the financial controller. Subcontracting with, for example, pharmacy, labs and/or monitors can then proceed (subject to approval by the Medical Ethics Assessment Committee), in consultation with the TDC.
It is the responsibility of the researcher(s) to take into account the deadlines for grant applications, as determined by funding providers.
5. Submission of the study to the Medical Ethics Assessment Committee
After funding has been secured, your study can be submitted to the Medical Ethics Assessment Committee of the hospital UMC Utrecht. For evaluation of the study by the Medical Ethics Assessment Committee, a research file needs to be compiled. You can discuss with the TDC which documents should be included in the file and set out the division of tasks. For more information on the research file to be submitted, please visit the website of the Medical Ethics Assessment Committee Utrecht. Your study will be submitted via Trial Support of the TDC; you do not therefore need to do this yourself. To contact Trial Support please e-mail: firstname.lastname@example.org). If you think your research is not subject to the Medical Research (Human Subjects) Act, the study needs to be submitted to the Medical Ethics Assessment Committee (as a non-Medical Research (Human Subjects) study) in order for them to confirm this.
6. Your study has been approved: congratulations! But what now?
Your study has been approved; however, you're still not quite ready to start your research. The following elements still need to be arranged.
Your study cannot proceed until the necessary contracts have been concluded. All contracts must be drawn up or reviewed by Legal before signing, to ensure that the contracts take sufficient account of Dutch legislation and of the interests of the Princess Máxima Center. Filing of the signed contracts is carried out by the TDC.
Site Initiation Visit (SIV):
Site initiation visits must take place so that everyone who is to participate in the study is properly trained in the necessary procedures. SIVs should be prepared by the researcher him/herself in close coordination with the TDC, due to the need for research nurses, data managers, the monitor etc. to be present at the visits.
7. Final check using checklist:
It is important to check that all the documents relating to the study are complete, and that all the above criteria have been met. The TDC has a checklist for this. The study can only proceed once this checklist has been completed in full.
Have you fulfilled all the above criteria? Congratulations!
You can officially start your study!