CONTRACT WITH SPONSOR. In order to ensure the same quality and safety standards in patient care for clinical research as commonly applied by the INSTITUTION in its regular activities, also in accordance with Joint Commission International standards, the SPONSOR shall comply with the following obligations: (a) the SPONSOR will use trained and qualified employees or contractors to manage and coordinate the Study; (b) the SPONSOR will ensure that multi-center Study reporting is reliable and valid, statistically accurate, ethical, and unbiased. The same requirements are applicable if multi-center Pseudonymized Personal Data and multi-center Study Results are provided to the INSTITUTION; (c) the SPONSOR will not grant incentives, other than standard compensations and reimbursement of costs, to Study Participants or to the INSTITUTION’s staff that would compromise the integrity of the research; (d) the SPONSOR is responsible for monitoring and evaluating the quality, safety, and ethics of the Study and will respect the INSTITUTION’s policies and processes reasonably known to SPONSOR when performing such monitoring and evaluation activities, provided that such policies and processes are not in conflict with Applicable Laws; (e) the SPONSOR will protect the privacy and confidentiality of the Study Participants in accordance with all Applicable Laws, as mentioned in this Agreement.
Appears in 6 contracts
Samples: Clinical Trial Agreement, Clinical Trials Agreement, Clinical Trials Agreement
CONTRACT WITH SPONSOR. In order to ensure the same quality and safety standards in patient care for clinical research as commonly applied by the INSTITUTION and INVESTIGATOR in its their regular activities, also in accordance with Joint Commission International standards, the SPONSOR shall comply with the following obligations: (a) the SPONSOR will use trained and qualified employees or contractors to manage and coordinate the Study; (b) the SPONSOR will ensure that multi-center Study reporting is reliable and valid, statistically accurate, ethical, and unbiased. The same requirements are applicable if multi-center Pseudonymized Personal Data and multi-center Study Results are provided to the INSTITUTIONINSTITUTION and INVESTIGATOR; (c) the SPONSOR will not grant incentives, other than standard compensations and reimbursement of costs, to Study Participants or to the INSTITUTION’s and INVESTIGATOR’s staff that would compromise the integrity of the research; (d) the SPONSOR is responsible for monitoring and evaluating the quality, safety, and ethics of the Study and will respect the INSTITUTION’s and INVESTIGATOR’s policies and processes reasonably known to SPONSOR when performing such monitoring and evaluation activities, provided that such policies and processes are not in conflict with Applicable Laws; (e) the SPONSOR will protect the privacy and confidentiality of the Study Participants in accordance with all Applicable Laws, as mentioned in this Agreement.
Appears in 1 contract
Samples: Clinical Trial Agreement