53 Study Monitor Information

21 1b

29 15 15 21 29 33

1d 17 3a

1b 1b 1b 7e

As a reminder, all visits, including virtual, must be scheduled.

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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.

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29 1 1 1 1 1 5b

1 2b

29 49 25 1f 1f 49 45 21 3b 21 25 1d

17 15 1c

a 1 16 27 16 2e 19 16 15 1 15 12 14

e 11 21 11 13