General
Definitions
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).
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.