EDC User Agreement

Prelude Electronic Data Capture System (EDC) User Agreement

Prelude, LLC of Austin, TX, operates the Prelude Electronic Data Capture System (EDC) in accordance with U.S. FDA’s 21 CFR Part 11 and EudraLex Annex 11 requirements, the General Data Protection Regulation (GDPR), and the Health Insurance Portability and Accountability Act (HIPAA).

Your Electronic Signature, executed using your unique username and password combination, carries the same legal significance as your handwritten signature.

Collection and Use of Personal Data

As part of identity verification, you are required to provide the information below, including a valid email address. Prelude will only use this information for account creation, identity verification, and compliance purposes. Prelude will not share your information with third parties except:

As required by law or regulatory authorities (e.g., U.S. FDA or other government agencies).
As necessary for system functionality and compliance with applicable legal and regulatory requirements.

Your name and email address may be visible to other authorized users of the EDC system, such as members of the study team, but will not be disclosed for any other purposes without your explicit consent.

You have the right to withdraw your consent for the processing of your personal data at any time by contacting [email protected]. However, withdrawal of consent may impact your ability to use the EDC system.

Confidentiality and Security Obligations

Information entered in the Prelude EDC system may include confidential personal health information (PHI) or personal data of study participants, including but not limited to:

Names, contact information, and identification details.
Medical histories, procedure dates, diagnostic reports, and treatment information.
Images, videos, and other related data.

By accessing the Prelude EDC system, you agree to:

Maintain the confidentiality of all personal data and PHI.
Report any forgotten, lost, or stolen passwords immediately and change your password without delay.
Not disclose your username or password to anyone, including staff members, employers, family members, or representatives of regulatory authorities, Prelude, or study sponsors.
Avoid unauthorized access to or disclosure of PHI and personal data during or after your access to the system.

Your Rights and Responsibilities

By checking the box in the Prelude EDC system, you:

Acknowledge your understanding, agreement, and acceptance of the information and requirements stated herein.
Agree that your Electronic Signature within the Prelude EDC system is the legal equivalent of your handwritten signature.
Accept responsibility for all actions performed under your account.
Understand your obligation to maintain PHI and personal data in the strictest confidence, in compliance with applicable laws, including GDPR and HIPAA.

For any inquiries or to exercise your GDPR rights (e.g., access, rectification, or erasure of data), please contact [email protected]