Data Processing Agreement Clinical Trials

– How the data is collected – How the data is used – How the data is stored – How the data is erased – Data source – Data transfer and transfer – Processing modes The mCTA is entered by the sponsor and the institution (i.e. the participating organisation), while the CRO-mCTA is to be used if, in addition to these two parts, the sponsor enters into contracts with a CRO, responsible for aspects of the management of field studies. The role assigned to the parties always reflects the position of the HRA and the business community, which considers the sponsor as responsible for the personal data and the participating organisation and the CRO as a subcontractor acting on behalf of the sponsor for the purposes of the clinical trial (clauses 6.2.1 mCTA and CRO-mCTA). There is no doubt that those responsible for active data in the field of clinical trials will welcome clarification in this area. It remains to be seen how ethics committees and national regulators will react to the EDSA opinion and whether this approach will be adopted in general, in particular as regards approval. In any event, data controllers in the field of clinical trials would be well advised to review their approaches in order to ensure compliance with the opinion. 5. Describe the purposes of the processing. – What do you want to achieve – Intentional effect on the persons concerned Whether or not the legal basis of the “public interest” can be relied upon depends on whether clinical trials “fall within the mandate, tasks and tasks entrusted to a public or private body under national law”.

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