契約書1-1_治験� ��約書（医薬品 ）_20200401.pdf

This contract is between Hiroshima University (hereinafter referred to as "Party A") and [Sponsor's Name] (hereinafter referred to as "Party B") regarding the implementation of a clinical trial (hereinafter referred to as "this clinical trial") for the investigational drug [Investigational Drug].

The contract outlines the terms and conditions for the clinical trial, including the responsibilities of both parties, the management of investigational products, monitoring, and confidentiality.

Key points include:

1. Party A will implement the clinical trial in accordance with the protocol and Good Clinical Practice (GCP) guidelines.
2. Party B will provide the investigational product and necessary information to Party A.
3. Both parties will ensure the confidentiality of the clinical trial and the privacy of the subjects.
4. Party A will manage the investigational product and maintain accurate records.
5. Party B will be responsible for monitoring and auditing the clinical trial.
6. Both parties will cooperate in the event of an audit or inspection by regulatory authorities.
7. The contract outlines the procedures for handling adverse events, serious adverse events, and other safety issues.
8. Party B will be responsible for the costs associated with the clinical trial, including the provision of investigational products and necessary equipment.
9. The contract includes provisions for the protection of intellectual property rights and the handling of confidential information.
10. The contract can be terminated or cancelled under certain circumstances, including non-compliance with GCP guidelines or regulatory requirements.

Overall, the contract aims to ensure the safe and ethical conduct of the clinical trial, while also protecting the rights and interests of both parties involved.