Common use of Review and Oversight Clause in Contracts

Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, CDC IRB will provide: a. initial and continuing review of materials related to the Expanded Access IND; b. review of amendments to materials related to the Expanded Access IND; c. review of local context considerations as provided by the Relying Institution; d. review of potential unanticipated problems involving risk to subjects or others as reported to the CDC IRB; e. review of serious or continuing noncompliance as reported to the CDC IRB; and f. oversight of the conduct of the Expanded Access IND to include the informed consent process.

Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, the CDC IRB will provide: a. initial and continuing review of materials related to the Expanded Access IND; b. review of amendments to materials related to the Expanded Access IND; c. review of local context considerations as provided by the Relying Institution; d. review of potential unanticipated problems involving risk risks to subjects or others as reported to the CDC IRB; e. review of serious or and/or continuing noncompliance as reported to the CDC IRB; and f. oversight of the conduct of the Expanded Access IND to include the informed consent process.

Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, CDC IRB will provide: a. initial and continuing review of materials related to the Expanded Access IND; b. review of amendments to materials related to the Expanded Access IND; c. review of local context considerations as provided by the Relying Institution; d. review of potential unanticipated problems involving risk to subjects or others as reported to the CDC IRB; e. review of serious or continuing noncompliance as reported to the CDC IRB; and f. x. oversight of the conduct of the Expanded Access IND to include the informed consent process.

Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, the CDC IRB will provide: a. initial and continuing review of materials related to the Expanded Access IND; b. review of amendments to materials related to the Expanded Access IND; c. review of local context considerations as provided by the Relying Institution; d. review of potential unanticipated problems involving risk risks to subjects or others as reported to the CDC IRB; e. review of serious or and/or continuing noncompliance as reported to the CDC IRB; and f. x. oversight of the conduct of the Expanded Access IND to include the informed consent process.