Data Collection
SafetyCall uses its own, proprietary electronic data collection tool, SafetyNotes™, to document interactions with callers. SafetyNotes™ is designed to ensure that all appropriate data is collected for the purposes of monitoring a product’s post-market surveillance experience and for developing a product safety profile. This data set includes but is not limited to:
- Caller and patient basic demographic information
- Product identification fields, including UPCs and identifying regulatory numbers
- Lot number collection
- Product use circumstance information, including a description of incident scenarios in appropriate context
- Route of exposure
- Patient management site (e.g. home, workplace, health care facility)
- Clinical signs and symptoms
- Severity assessment may be added as an additional service
- Consistency assessment and scoring may be added as an additional service
- CRC codes (consumer inquiry codes) may be configured to meet Client needs
Data Access
SafetyCall clients will have access to their electronic case data via the Internet using SafetySearch™, a secure password protected web-based search tool. SafetyCall clients may also use SafetySearch™ to download case data into a comma delimited file (.csv), a standard file format that may be imported to internal Client information systems.
With SafetySearch™, clients are able to:
- View case detail reports
- Search case data by selecting various criteria
- Download case data into a comma delimited file
- View attachments to cases such as consumer emails or image files of letters
Record Retention
Records of all adverse event experiences reported to SafetyCall and documented in SafetyNotes™ shall be maintained for a period of no less than 30 years.