Approved version 2.4
1. Purpose and Appointment
This agreement applies to a Clinical Investigator registering in the PTP-102 Trial Portal. The investigator is appointed to perform the investigator responsibilities described in the approved protocol and supporting study documents, subject to this agreement and applicable law.
2. Investigator Responsibilities
The investigator will conduct the study in accordance with the protocol, applicable law, ethics and animal welfare requirements, and professional standards. The investigator will ensure appropriate training, delegation, and supervision of study activities, and will maintain accurate, timely, and complete source records and study documentation.
3. No Off-Protocol Use
The investigator may use investigational products, study materials, systems, and data only for the study and only as authorised. Off-protocol use, transfer, sale, modification, or unauthorised access is not permitted.
4. Consent, Privacy, and Data Protection
The investigator will obtain and document all required owner or client consents and approvals before performing study procedures. Personal data and regulated information must be handled in accordance with applicable data protection laws, privacy notices, and study requirements. Use coded identifiers where practicable and minimise personal data shared.
5. Safety Reporting and Deviations
The investigator will promptly report safety events, product complaints, protocol deviations, and inspections within required timelines, and will cooperate in investigations, corrective actions, and monitoring.
6. Confidentiality
The investigator will protect confidential information and use it only for permitted study purposes. Disclosure is limited to authorised personnel who need to know and are bound by appropriate confidentiality obligations.
7. Publication and Communications
Publications or public statements about the study require prior review under the study publication process. The investigator must not use Byrock names, marks, or confidential information in marketing or endorsements without express written permission.
8. Compliance, Suspension, and Termination
Byrock or the portal operator may suspend or revoke access for misuse, non-compliance, or safety concerns. On termination, the investigator will stop unauthorised activities, complete required safety and close-out tasks, and return or delete confidential information as instructed, subject to lawful retention.
9. Governing Law
This agreement is governed by the laws of Ireland, subject to mandatory local law.