Withdrawal of consent

  Normal  0          false  false  false    EN-US  X-NONE  X-NONE                                       MicrosoftInternetExplorer4                                                                                                                                                                                                                                                                                                                             Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

The official FDA guidelines for sponsors and clinical investigators state:

"If a subject withdraws from the interventional portion of the study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent. However an investigator may review study data related to the subject prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status." Template:WH Template:WS