Sponsors and study investigators are required to report information that may represent unanticipated problems involving risks to participants and others to Goodwyn Institutional Review Board within 10 working days.

Updates and Alerts Report Form *    **

* The DOC file format requires that you have Microsoft Word '97 or higher installed on your computer. If you do not, please use PDF format.
** The PDF file format requires that you have the Adobe Acrobat Reader installed on your computer. If you do not have this program installed, you may download and install a free copy by clicking the icon below:

An unanticipated problem is one that is (1) unforseen and (2) indicates that participants or others are at increased risk of harm. Unanticipated problems involving increased risk might be indicated in the following:

•IND safety letter
•breach of confidentiality
•summary of interim analyses and DSMB reports
•new publications and labeling changes
•subject compaints that indicate unexpected risks
•audit reports
•reported or observed non-compliance
•other events that may represent unanticipated problems