Records concerning controlled substance research must be maintained for five years after completion of the study and must comply with regulations set forth in 10 NYCRR 80.100. The PI is responsible for stating whether or not he or she has a conflict of interest with respect to the research study. All conflicts should be disclosed to the IRB and sponsor. All required reportable events will be reported to the IRB within the deadlines specified in the IRB policy, as summarized in the table below: Event Type Deadline from when the Comments investigator first learns of an internal event for reporting to IRB for an internal event (e.g., those that occurred with within the DMC IRB’s jurisdiction) (or Report findings within 24 The study team should alert Government inspection audit) hours, if any serious or the IRB when the inspection is continuing non-compliance scheduled or if an inspector was found or proposed; arrives unannounced, so the otherwise within 5 days. IRB may help as needed. Privacy Violation (or Immediately report this to IRB Breach). and Privacy Officer Immediately report this to IRB Information (Data) Security and Data Security Officer Violation (or Breach). Incarceration of a research Immediately, if participant is actively incarcerated; participant. otherwise within 5 days Any FDA Actions or changes Immediate to a HUD. Serious Adverse Event. 24 hours, if in Clinical Trial When reporting a death, when the AE meets all of the please include the date of An AE or SAE may also meet following criteria: death, if known. the definition of an UPIRPO,
Records concerning controlled substance research must be maintained for five years after completion of the study and must comply with regulations set forth in 10 NYCRR 80.100. The PI is responsible for stating whether or not he or she has a conflict of interest with respect to the research study. All conflicts should be disclosed to the IRB and sponsor. All required reportable events will be reported to the IRB within the deadlines specified in the IRB policy, as summarized in the table below: Event Type Deadline from when the investigator first learns of an internal event for reporting to IRB for an internal event (e.g., those that occurred with within the DMC IRB’s jurisdiction) Comments Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise within 5 days. The study team should alert the IRB when the inspection is scheduled or if an inspector arrives unannounced, so the IRB may help as needed. Privacy Violation (or Breach). Immediately report this to IRB and Privacy Officer Information (Data) Security Violation (or Breach). Immediately report this to IRB and Data Security Officer Incarceration of a research participant. Immediately, if participant is actively incarcerated; otherwise within 5 days Any FDA Actions or changes to a HUD. Immediate Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, 24 hours, if in Clinical Trial when the AE meets all of the following criteria: When reporting a death, please include the date of death, if known.