Study Monitor Information
As a reminder, all visits, including virtual, must be scheduled.
| Facilities | Central | Smilow | North |
|---|---|---|---|
| Controlled R/T (20-25°C) | √ | √ | √ |
| Refrigeration (2-8°C) | √ | √ | √ |
| Freezer (-20°C) | √ | √ | √ |
| Freezer (-80°C) | √ | √ | √ |
| Liquid Nitrogen (-180°C) | |||
| Emergency Generators | √ | √ | √ |
| Quarantine | √ | √ | √ |
| USP <800> Compliant | √ | √ |
Security
Central & Smilow: Electronic locks, cameras
North: Key/code combination locks, cameras
Deliveries
IDS delivers to clinics or infusion suites with an electronic chain of custody. Charges may apply depending on the distance. If picking up directly from IDS, must present a PennCard or UPHS ID (CHOP and Wistar Staff - obtain a courtesy PennKey).
Temperature Monitoring
Electronic and continuous charts uploaded into Vestigo™.
Central & Smilow: Comark
Smilow & North: Aeroscout
Recordkeeping
Electronic and Vestigo™. Must request electronic access during visit. Both FDA and EMEA consider IDS logs to be valid source documents.
Archival
Documents maintained for minimum of 20 years. IDS uses the Penn Records Center.
Visit Scheduling
- All visits will be conducted remotely. Onsite visits are not permitted.
- All visits must be scheduled in advance (use APP).
- Minimum notice: SIV, feasibility and virtual tours - 10 business days; IMV/Audits/COV - 5 business days
- IDS requires 4 weeks’ notice before first enrollment.