 |
|
| THE HUMAN RESEARCH PROTECTION PROGRAM |
|
THE COMMITTEE ON HUMAN RESEARCH MANDATORY USE OF FORMS FOR SUBMITTING ADVERSE EVENT, VIOLATION/INCIDENT AND OTHER POST-APPROVAL REPORTS The following forms are required when submitting Drug or Device Brochures, or Adverse Events Reports: These forms assist the CHR Chairs and staff in dealing with the enormous volume of post-approval reports because they ask researchers to summarize information in a consistent way, analyze the importance of safety information, and then make decisions about whether an approved protocol and consent form need to be modified. As you know, this kind of investigator analysis (instead of mere paperwork) is the important aspect of post-approval reporting. If you need assistance with the forms or have any general questions about post-approval reporting, please call the CHR office at 476-1814.
|