Definitions Flashcards
Define the term:
Personal data
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
any information relating to an identified or identifiable natural person
Define the term:
Controller
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
controller is in charge, determining the “purpose and means” of the processing (why the personal data is collected in the first place) e.g., the Sponsor.
Define the term:
Processor
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
Processor only processes personal data on behalf of the controller. It does not have autonomy in relation to the processing e.g., cloud-based hosting services, CROs in the clinical context.
Define the term:
Joint Controller
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
two or more controllers determine the purposes and means of processing jointly of through converging decisions
Some EEA/UK countries classify Sponsor & Site as “joint controllers”
Define the term:
Special categories of personal data
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
expressly includes genetic data
Define the term:
Pseudonymisation
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
The processing of personal data in such a manner that data subjects cannot be identified without additional, separate information e.g.,key-coded data from clinical trials in the hands of the Sponsors.
Reduces risk but importantly pseudonymous or key-coded data remains personal data.
Define the term:
Processing
The EU General DataProtection RegulationTraining Deck
Clinical Operations Training - Slide 5
very broad, any operation or set of operations which is performed on personal data or on sets of personal data. Includes collection from patients, consultation, use, deletion, disclosure (for example, to CRO).
