Informed Consent; IRB Approval Clause Samples

Informed Consent; IRB Approval. MD ▇▇▇▇▇▇▇▇ and the Investigators, in consultation with Tokalas or its designee, shall create the site-specific informed consent form and authorization valid under HIPAA and FDA regulations, as applicable to the TK 216-01 clinical trial. The informed consent form and any subsequent modifications shall be subject to the approval of Tokalas and the IRB. The authorization and any modifications to it shall also be subject to the approval of Tokalas. Prior to commencing the clinical trial, MD ▇▇▇▇▇▇▇▇ and the Investigators shall obtain and provide to Tokalas or its designee all regulatory documentation required by the TK 216-01 clinical trial protocol and Laws, including the written approval of the IRB, a completed and signed Form FDA 1572, and completed and signed financial disclosure questionnaires. The financial disclosure questionnaires shall be updated as necessary throughout the conduct of the clinical trial and for a period of one (1) year thereafter.