Compile the file
The following are mandatory for a valid application:
- Cover letter of the investigator
- Protocol (+ summary)
- Suitability/competence of the principal investigator/promoter by means of CV
- GDPR questionnaire
If relevant for your study, the following components are also submitted:
- Method of recruitment - Recruitment material
- Information and consent form, patient documents
- Suitability of the facilities/agreement involved supporting services
- Contracts/ financial agreements.
E.g. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, etc.
For example: template for research with artificialised and extracted material when they are not used for genetic research
For artificialised and extracted material, when they are not used for genetic research it suffices to submit the research project and its purpose to EC Research. The researcher is responsible for complying with all conditions (i.a. not being used for genetic research…) and confirms this in a (short) template we provide (cf. highlighted below). If EC Research does not express any concern within 28 (calendar) days after receipt of the research project and the completed declaration, the research project can start and registration in a biobank is not needed anymore. It also implies that artificialised and extracted material, when they are not used for genetic research, can be imported and exported without the need to involve a biobank, can be used without consent of the donor, are not subject to traceability requirements (towards the donor) and are exempt from obligations to report incidental findings.
Prepare the file
Only one file per component can be uploaded.
Do you have several files per component? Group them in a compressed folder (zip-file).
Submit the study
When you start your application, you need to complete the whole process.
Do you have all the components?