Term of the Day
Natural History Study
A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.
Standard contractual clauses (SCC)
Standard contractual clauses (SCC) are legal tools to provide adequate safeguards for data transfers from the EU or the European Economic Area to third countries.
The European Commission has adopted three Decisions declaring Standard Contractual Clauses to be adequate, and therefore, companies can incorporate the clauses into a transfer contract, but the clauses can't be modified. Four modules were created to accommodate each transfer situation: controller to controller, controller to processor, processor to processor and processor to controller.
In principle no authorisation is required from data protection authorities to be allowed to use these clauses. A formal notification to the authority might nevertheless be necessary.