10928. INSPECTIONS

10928 INSPECTIONS 10928.1 A sponsor or an investigator who has authority to grant access shall permit authorized Department employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept). 10928.2 A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized Department employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation. 10928.3 An investigator shall permit authorized Department employees to inspect and copy records that identify subjects, upon notice that the Department has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10928