Master Protocol. The Master Protocol – incorporated by reference and sent under separate cover -- is reviewed and approved by a central Institutional Review Board (“Central IRB”) at MGH. Sites have agreed to cede review of the Master Protocol to the Central IRB pursuant to a separate reliance agreement between MGH and the Sites. For each Study Regimen in which a Site participates, the Site will provide all the necessary qualified personnel, equipment, materials and facilities to accomplish the research as set forth in that Central IRB-approved Master Protocol. Each Site will represent and warrant that it shall:
a) assume all responsibility to enroll and follow human subjects participating in the Study according to the most recent approved version of the Master Protocol;
b) comply with all institutional and federal regulations concerning informed consent;
c) confirm approval of the Master Protocol and subject consent form(s) from the Central IRB prior to commencement of human subject research under a Task Order;
d) obtain local ancillary approval(s) as necessary;
e) follow all Site policies and procedures with respect to the conduct of the activities under the Master Protocol; and
f) ensure regulatory compliance, as outlined in applicable FDA regulations.
g) agrees not to knowingly employ or otherwise engage any individual or entity in connection with performance of the XXXXXX ALS Platform Trial that is presently or has ever been: (i) the subject of a debarment action or is debarred pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act of 1938, as amended, or other Applicable Laws; (ii) the subject of a disqualification proceeding or is disqualified as a clinical investigator pursuant to Title 21 of the United States Code of Federal Regulations ("C.F.R.") Section 312.70, or other Applicable Laws; or (iii) the subject of an exclusion proceeding or excluded from participation in any federal health care program under 42 C.F.R. Part 1001 et seq., or other Applicable Law (as indicated by an appearance on the List of Excluded Individuals/Entities maintained by the Office of Inspector General of the Department of Health and Human Services, the Excluded Parties List System maintained by the U.S. General Services Administration, or other applicable exclusionary databases).
Master Protocol. The Master Protocol – incorporated by reference and sent under separate cover -- is reviewed and approved by a central Institutional Review Board (“Central IRB”) at MGH. Site has agreed to cede review of the Master Protocol to the Central IRB pursuant to a separate reliance agreement between the Parties. For each Study Regimen in which the Site participates, the Site will provide all the necessary qualified personnel, equipment, materials and facilities to accomplish the research as set forth in that Central IRB-approved Master Protocol. Site represents and warrants that it shall:
a) assume all responsibility to enroll and follow human subjects participating in the Study according to the most recent approved version of the Master Protocol;
b) comply with all institutional and federal regulations concerning informed consent;
c) confirm approval of the Master Protocol and subject consent form(s) from the Central IRB prior to commencement of human subject research under a Task Order;
d) obtain local ancillary approval(s) as necessary;
e) follow all Site policies and procedures with respect to the conduct of the activities under the Master Protocol; and
f) ensure regulatory compliance, as outlined in applicable Food and Drug Administration (“FDA”) regulations.
