Review and Regulatory Submission. Institution and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Institution and Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Master Clinical Trial Agreement, Clinical Trial Agreement
Review and Regulatory Submission. Institution Provider and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Institution Provider and Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer.and
Appears in 1 contract
Samples: Clinical Trial Agreement
Review and Regulatory Submission. Institution Provider and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Institution and Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer.if
Appears in 1 contract
Samples: Clinical Trial Agreement
Review and Regulatory Submission. Institution and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Institution and Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer.
Appears in 1 contract
Samples: Clinical Trial Agreement