Data Sharing Agreement Template Ccmo

If the proponent has submitted an unsigned version, the proponent must submit a signed clinical trial agreement to the audit committee before the start of the study. The attached letter indicates whether the provisions of the signed research contract, assessed by the Review Committee, have been amended. This is based on the principle that the signed version must be the same as the version approved by the Review Committee. The use of the term “data exchange” is also not clear in itself. Many legislative and legal documents contain statements on data sharing; However, data exchange may, in practice, relate to a variety of activities. It may, for example, refer to the type of sharing (the physical transmission of data to users in relation to distributed access), access and use (in relation to conducting analyses only) or scope (recent study compared to future studies). In such cases, it will be important to understand what these guidelines and rules actually mean by “data exchange.” In order to promote responsible data exchange in the field of health research, it is necessary to establish ethical governance that complements the EU`s general data protection regulation. A governance framework for big data-based research platforms must at least take into account the pre-set conditions for individual datasets. The aim is to identify and analyse these conditions for the platform BigData@Heart of the Innovative Medicines Initiative (IMI). At the beginning of the BigData@Heart in March 2017, 46 records were listed in the Action Description (DoA) to provide patient data for more than 25 million people. Seven main sources of data were mentioned: (1) genetic collections based on disease (acute coronary syndrome, arm fibrillation, heart failure) (2); disease-based collections, including omics data (3); data on online health data (5) (4) on a hospital basis; (consensus) population-based cohorts (5); Healthy population cohorts with Omics; and (6) clinical trial data.

The following characteristics were extracted from each of the 46 records: the name of the data set (usually study acronym); The Lead Investigator (PI) and/or Data Manager; Ip organization IP and/or data manager contact information The nature of the data Designing the studies The cohort/sample size countries.