Summary
Data management and validation planDMPs should cover strategy for all data in the project and how they can be made available as from the rules 30days Protection of personal data1 The consortium must ensure that the following is addressed in the Data Management Plana detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participantsb the consortium must confirm that the specific data protection informed consent forms and information sheets in language and terms intelligible to the participants are kept on file in case this is not addressed in the informed consent procedures for human participants They must be provided to IMI JU upon request2 Details on the data which will be collected during the phone call at Day 28 within Clinical Study 1 CT p 6 must be provided
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