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Training
|
- Documented in employee files
- Annual trainings
-
SOPs (more if changes occur)
- ICH/GCP
- ICF, AE reporting
- Continuous training on Protocol, ICF and Amendments
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QA/QC
|
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Lab and Pharmacy Capabilities |
| Lab |
- Specimens packed/shipped/stored per lab manual/protocol
-
Dry ice delivered 2x/week
- Samples are shipped via courier designated by protocol
- Central or local labs or both
- Locked and monitored refrigerators/freezers for storage
- All temperature logs are archived on site permanently
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| Pharmacy |
- Pharmacist
-
Dry ice delivered 2x/week
- Study coordinator unless separate pharmacist required
- Certified pharmacy technicians on staff
- Access and Accountability
- Limited access via triple locked doors
- Full accountability records maintained
- Mixing
- Luminar FlowHood for sterile mixing
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Document Management/Archiving
|
- TMF per study
-
Source document version control
- ICF document version control
- Onsite locked storage
- Offsite long-term storage at Iron Mountain
- 24-hour document retrieval
- Shred-It for confidential document disposal
- Computer backup at 2 offsite locations
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