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 If your project contains both prosective and retrospective aspects, please choose prospective


Prospective studies include any collection and analysis of "new/future" and/or "existing" data. Data are collected from patient records, questionnaires, blood draws, interviews, etc. during a routine consultation (non-interventional) or an additional study visit (interventional). This type of research (= "experiment") falls under the Belgian law of 2004 and/or 2017 or 2020.

All retrospective studies are considered non-interventional (= observational).
Retrospective studies involve the analysis of existing data (i.e. collected in the past). Data are usually obtained through patient records. It is also possible to collect the data via a questionnaire if 1) it is completed by a third party (i.e. the patient is not contacted) and 2) only past information/data is collected. The end date of data collection is therefore always situated before the start of the retrospective study (data collection: January 2020-2021; start of study: February 2021).
This type of research is not covered by the Belgian law of 2004 or 2017. If one wants to publish the results of a retrospective study, we strongly recommend to submit the protocol of the retrospective study for approval (= before performing the analysis) to the medical ethics committee of the hospital where the data were collected. In contrast to this, it should be noted that research involving a medical device is covered by the Belgian law of 2020 (MDR).

(according to the Belgian law: "trial/experiment"): Future data are being collected in these clinical trials. An interventional study includes all research that deviates from standard care (= care provided during a planned consultation/intervention). A few examples:
  • Additional blood sampling, RX, CT scan, etc..
  • Administration of an experimental medicinal product or an existing medicinal product with a different dose, formula, or for a different application.
  • A medical device/therapy/surgery without CE marking or outside the approved domain.
  • Questionnaires/Interview conducted during an additional study visit in hospital or at home.
  • Randomisation of participants receiving an approved drug, medical device or therapy.

If the study takes place in one particular center (AZG), then the study is monocentric.