Explanatory notes study EC Research

Cover letter of the investigator

European "application form" - EC Research

EudraCT studies (studies involving medicines) require an additional form to be submitted. This can only be done after the study has been registered at the European Medicines Agency (EMA) and an EudraCT number has been assigned.

Protocol - EC Research

A concrete and detailed protocol relating to all procedures must be submitted. For academic studies you use the provided template. You submit a summary and deliver a scientific opinion of EMA, FDA or other regulatory governments.

https://www.uzleuven.be/nl/ethische-commissie-onderzoek/toelichting-onderdelen/investigators-brochure-wetenschappelijke-bijsluiter Investigator’s brochure - summary of product characteristics - EC-Research

An Investigator's Brochure (IB) is a summary of clinical and pre-clinical data on investigational drugs the pharmacological aspects of which are not yet or not sufficiently known and which are important for studying the investigational drug in subjects.

Method of recruitment - recruitment material- EC Research

Drawing up an informed consent form (ICF)

Suitability-competence principal investigator-promoter - EC Research

CV of the study's principal investigator containing sufficient information for the EC to assess the suitability/competence of the principal investigator. A Good Clinical Practice (GCP) certificate that is no more than 3 years old must also be reported.

Suitability of the facilities/involved supporting services - EC Research

Proof of no fault insurance - EC Research

If the study falls under the Belgian Act on experiments on human beings (7 May 2004), a (no-fault) insurance certificate must be submitted to EC Research.

Info of local ECs + proof of simultaneous submission to the local ECs - EC Research

In a multicentric study, proof of simultaneous submission to the ECs of all participating centres is required. If EC Research acts as the central EC in the study, this proof needs to be provided to EC Research.

GDPR questionnaire - EC Research

To facilitate the contract review by the CTC's legal department and enable the privacy review by the EC, please complete the GDPR questionnaire as soon as possible after the S-number has been assigned.