CRO recognizes the persistent desire to provide services to the sponsor. and seven. informed consent. CRO recognizes that the project will require two separate documents of informed consent: one document on informed consent for the analysis of tissue/biomarker screening and the other for the therapeutic clinical trial that includes part of the project. These consent documents, knowingly, must be approved by the promoter. CRO requires that the informed consent of each subject be obtained in accordance with all applicable laws, including the completion of the information; These documents relating to informed consent contain, among other things, information on the collection and retention of samples and on a possible follow-up analysis (together “Informed Consent”) (when such informed consent is obtained, a potential subject is considered a “subject”). For clarity, the document states that any indication of the subject expressly indicates that each subject understands that the proponent supports the project and authorizes the disclosure of project data and results to the sponsor for all intents and purposes, subject to any applicable law. For reasons of clarity, CRO is not required to obtain prior written approval from the promoter for subsequent changes that are not materially different from the form originally agreed by the proponent or for translations of that form; provided that cro is solely responsible for the fact that subsequent modifications and translations do not deviate materially from the form agreed by the promoter. Cro requires that informed consent be obtained from each subject before the product is administered to each of these subjects in accordance with protocol. 16.
Pharmacovigilance. CRO undertakes not to conduct clinical activities involving pharmacovigilance obligations for the product prior to the implementation of a pharmacovigilance agreement submitted by the sponsor. 7.3 Cro property and foreign ownership. The Proponent recognizes that certain intellectual property titles developed, acquired or otherwise acquired by CRO before or independently of this agreement (a “cro property” package) and certain intellectual property rights that have been granted or acquired by cro by third parties (“third party property”) may be used by CRO in the performance of services under this agreement.