Study types and flow

Study types

Industry-sponsored research	Study started by a commercial company (pharmaceutical company, CRO, etc.)
Academic research	Study started by a hospital, university, educational research, etc.
Interventional	A study which deviates from the standard care This might be through randomisation, extra blood draws, additional medical imaging, medication at other doses, new medication, etc.
Observational	A study in which there is no deviation from the standard care and the therapeutic strategy is not determined by the study protocol. Questionnaires may be administered.
Retrospective studies	A study performed using collected/available data.
Monocentric studies	A study only performed at one location (e.g. only at the Maria Middelares General Hospital).
Multicentric studies	A study performed at multiple centres/hospitals.
Compassionate use (CU)	The patient receives a medication that is not yet registered, whereby the patient's quality of life improves significantly.
Medical Need	The patient receives a medication that is already registered and that people now would like to be used for a different indication.

Registration for EC at the Maria Middelares General Hospital

A clinical study can only be initiated after approval from the authorised ethics committee and the completion of a Clinical Trial Agreement (CTA), in case various other legal entities are involved. Please see the flowchart below for an overview of the authorised bodies and/or authorities in relation to the type of study.

If you would like to initiate a study at the Maria Middelares General Hospital, you must register with the team that will preferably be conducting the study. The contact information from the various study departments can be found at our team page. Please contact the relevant study service. The request will be reviewed internally and the research department (or representative) will respond with feedback to your request.

Workflow

Only available in Dutch:

Studietypes

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Useful documents

Only available in Dutch:

Benodigde documenten

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Documents for requesting advice from the ethics committee of Maria Middelares General Hospital

Please see below for an overview of the necessary documents to be submitted to the EC with the Maria Middelares General Hospital. Documents should be numbered according to the guidelines: MMS number followed by the document number (e.g. MMS.year.XX_document number). Since the EC only assigns the MMS number at the time of actual submission, please use ‘XXX’. The study coordinator will add the number to the document at a later point.

Choose the applicable request document:

Request form:

Explanations and approval form (not applicable for retrospective studies)
CV and GCP certificate investigators
Study protocol
Questionnaires
Attestation of faultless liability insurance (not applicable for retrospective studies)
(Proposal for) Clinical Trial Agreement
The recommendation of the DPO when the EC with the Maria Middelares General Hospital acts as LEC and/or when the Maria Middelares General Hospital/physician is the responsible party for processing (project manager)
Financial identification document (document E) (only for industry-sponsored studies)

Once these documents are completed and signed, they will be e-mailed to the study coordinator of the research department to which you have applied. They will forward the documents to the EC.
The study coordinator will receive a confirmation within 3 business days via e-mail once the EC has properly received the documents. If the study is independent, start the EC evaluation procedure. This will take 28 days.
The investigator is given 60 days (2 months) to formulate a response to the EC's comments.
The modified documents are delivered to the EC both in a version with track changes and in a clean version with a modified version date.
If no notification is received by the deadline, this application file will be closed without any advice given.
The approval will be communicated in a letter via e-mail.

Data Protection Officer (DPO) documents

In a monocentric study or multicentric study where the Maria Middelares General Hospital is the lead ethics committee (EC), the recommendation of a local data protection officer (DPO) is required. A favourable recommendation from the DPO must be obtained before the application can be submitted to the EC.
In a multicentric study, where the Maria Middelares General Hospital is not acting as the lead EC and is not a data controller, the recommendation of the local DPO is not required.

The recommendation of the DPO is always required if the Maria Middelares General Hospital is the data controller.

Submit a recommendation request using the template provided for this purpose, which the study coordinator of the relevant research department sends to the DPO responsible for checking whether the study complies with GDPR legislation. Any comments will be sent by e-mail.

If the Maria Middelares General Hospital is the data controller, a processing agreement with any external processors is required. See here for a template:

Processing agreement NL
Processing agreement ENG

Study Agreement or Clinical Trial Agreement (CTA)

At a minimum, the contract will be tripartite (three contracting parties: the sponsor, physician investigator and the hospital).

During the study

During the study, there are some things that need to be communicated to the EC. These things include serious side effects (SAEs), amendments (even if our EC is not the LEC), an annual progress report of the study and the cessation of the study. An amendment can be requested no earlier than three months after the last approval. For this purpose, an e-mail may be sent directly to the EC and the study coordinator in CC. Do not forget to include the MMS number with all correspondence with the EC