Real-World Testing Informed Consent

Obtain and document legally sufficient informed consent for Article 60 real-world testing.

Where informed consent is required for real-world testing, give participants concise, understandable information before they take part. Cover the test, duration, possible inconvenience, rights to refuse or withdraw, reversal or disregard arrangements, test identifier and contact information as applicable. Date and document consent and provide a copy to the participant or legal representative. Make the refusal and withdrawal process workable. Assess any narrowly applicable law-enforcement alternative separately; do not assume that consent alone authorizes the test or all data processing.

Before each participant takes part where required; on relevant information changes; on refusal or withdrawal.

Participant information and consent form versions Dated consent and copy-delivery records Test identifier and contact details Refusal, withdrawal and follow-up records Documented basis for any applicable alternative

Sample a participant record and confirm that valid information and documented consent preceded participation and that a copy was provided. Walk through withdrawal and verify that staff can apply the stated arrangements.