10919.1A sponsor shall monitor the progress of all investigations involving an exception from informed consent under 21 C.F.R., part 50. When the sponsor receives from the IRB information concerning the public disclosures under 21 C.F.R. §50.24(a)(7)(ii) and (a)(7)(iii), the sponsor shall promptly submit to the IDE file and to Department, copies of the information that was disclosed, identified by the IDE number.
10919.2The sponsor also shall monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in 21 C.F.R. §50.24(a) or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to the Department, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation.
authority
Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.
source
Final Rulemaking published at 60 DCR 10252 (July 12, 2013).
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