Clinical Trial Patient Confidentiality Agreement

This Confidentiality Agreement (“Agreement”) is entered into between:

Trial Sponsor/Institution:

Patient Name:

Clinical Trial Title/Study ID:

1. Purpose

The purpose of this Agreement is to ensure that all information regarding the clinical trial, as well as information related to the patient, is treated as confidential and protected according to applicable laws and regulations.

2. Confidential Information

For the purposes of this Agreement, "Confidential Information" includes but is not limited to:

• Personal health information provided during the clinical trial
• Medical records and reports
• Study data and results related to the patient
• Any other information disclosed during the course of the trial

3. Obligations

1. The Trial Sponsor/Institution agrees to maintain the confidentiality of the patient's information.
2. Confidential Information will not be disclosed to third parties except as required by law or regulatory authorities.
3. The patient’s data will be anonymized or coded when reported or published.

4. Exceptions

Confidential Information may be disclosed if:

• Required by law or court order;
• With the patient’s explicit written consent;
• As necessary to report adverse events or for regulatory compliance.

5. Duration

This Agreement remains in effect throughout the duration of the clinical trial and continues thereafter, as required by law.

6. Acknowledgment

By signing below, the parties confirm that they have read, understood, and accept the terms stated above regarding confidentiality.