Under FDA regulations the First Dynamic Review Board is an appropriately constituted group that is authorized to approve protocols and consent forms and review and monitor human subjects. The primary purpose is to protect the rights and welfare of humans participating as subjects in clinical trials. The board maintains a communication channel between the sponsor, chief investigator, the board chairperson, and members of the board in compliance with title 21 CFR part 50 and 56.

• Initiated in 1975
  
• Satisfactory FDA audit 1989 and 1999
  
• Satisfactory Sponsor Audit 1998

Pharmaceutical companies and other organizations requiring review of protocols involving 1572 forms and other IRB sanctions.

• Meetings held upon request from sponsors of clinical investigational studies

• Committee members are given two weeks for review of protocol and consent forms prior to voting approval or disapproval

• Investigator brochure required prior to completion of review 21 CFR 321.23(a)5 and 312.55

• IRB Chairperson notifies chief investigator of boards decisions

• All adverse reactions must be reported to the IRB by the chief investigator

• Interim reports by chief investigator to the IRB are required

• Expedited review practices may be inacted

• Report of findings to sponsor and chief investigator within 48 hours

• Cost of IRB review is at a competitive rate

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Contact Information

First Dynamic Health Care Services, Inc.
Mark Bryant, Chairperson
5010B Lakeland Circle
Waco, TX 76710 USA
Phone: 254-754-1970
Fax: 254-754-4494
E-mail:

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