You can stop a participant being enrolled in the eCRF, or being sent an ePRO survey, until both the participant and the site have signed the eConsent. It is how you make sure no data collection starts before consent is documented.
Turn the requirement on
đ ď¸ Step by step guide
Go to your study.
Scroll down to Study settings and open the Options tab.
Click Edit.
Under Signature needed, switch on one or both sliders: eCRF blocks enrollment in the eCRF, ePRO blocks sending ePRO surveys.
Click Save.
â ď¸ Warning: this applies only to new inclusions made after you switch it on. Subjects already in the study are not affected, and turning it on will not retrospectively flag anyone enrolled without a signed consent. If that matters for your study, check the existing subjects yourself.