Once a parent has sent in the signed Informed Consent Form, Bill of Rights, and Physician List and Medical Examiner Form, the child will be assigned a study number and the following steps will be taken by the researchers:

A. Medical Case Review
A letter describing the SUDC study and a copies of the signed Informed Consent Form will be sent to each of the child’s physicians and to the child’s medical examiner requesting the release of the child’s materials. The consent form authorizes the release of the child’s materials, which include medical records, microscopic slides, tissues, fluids, and x-rays. The parent will be contacted if further release forms need to be completed by a physician’s office or hospital.

The Family Survey and/or other written historical information for the child are sent to the Study Site by parents within a month from the start of study participation.

All materials are received and reviewed by the Principal Investigator. If necessary, certain records or materials will be sent to other members of the research team for their review and/or analysis.

The parents may be contacted and asked to provide further information, if necessary for the review process.

Once the review process is completed, parents will be sent a copy of the Principal Investigator’s letter regarding his findings that is submitted to the medical examiner who performed the child’s autopsy. Parents will also be given the option of speaking directly with the Principal Investigator over the phone to ask any questions they may have about the review.

B. Research Purposes
Each child’s data will be entered into the SUDC research database. When an appropriate number of cases have been reviewed and entered into the database, the data will be searched for trends and analyzed with respect to different variables.

Data analysis will be reported on through abstracts, presentations, and peer-reviewed journal articles.