Emergency BU Alert BU Medical Campus OPEN Jan. 28, 2015 Boston University Medical Campus will be open Wednesday, Jan. 28, 2015. BUSM classes will be held as scheduled. Staff should check with their managers regarding work schedules. Medical, PA and GMS students who are assigned to inpatient services or clinics are expected to be present, if possible. Students who are assigned to outpatient services should check with their course director or the policy at the clinical site. GMS classes are canceled. Staff should check with their manager regarding their work schedules. The Henry M. Goldman School of Dental Medicine will follow normal school hours. All Patient Treatment Centers will be open for patient care and all classes will be held as scheduled. BU School of Public Health classes are canceled; SPH non-essential staff may telecommute. Employees who are part of the BUMC parking program should park in your assigned lot or garage. The Boston parking ban is still in effect. For updated information, please call the weather/emergency hotline at 617-638-6886 or visit the BU Emergency Communications website at http://www.bu.edu/ehs/comm/

Reporting Unanticipated Problems & Adverse Events

The IRB is no longer accepting (as of November 1, 2007) reports of individual AEs and SAEs unless they represent Unanticipated Problems. The requirements for reporting of AEs and SAEs have changed significantly.

  Click here for a checklist for investigators to use to assess their current compliance with AE and UP reporting requirements and plan for future reporting

  Click here for the November 2007 Clinical Research Seminar: Reporting Unanticipated Problems and Adverse Events: A Change in Policy

  Click here for a printer friendly copy of the October 2007 CR Times article that explains the changes in detail.

  Click here for the Instructions on how to complete the UPSER form in INSPIR (to report Unanticipated Problems and summaries of Adverse Events)

  Click here for a copy of the Unanticipated Problem and AE reporting Algorithm

  Click here for a table showing How and When to Report AEs and Unanticipated Problems

  Click here for the Reporting Cheatsheet

  Click here for a letter to sponsers regarding the change in our policy for reporting to the IRB AEs, and Unanticipated Problems

  Click here for a DSMP template for non-GCRC studies


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