Professional Documents
Culture Documents
• Dr Pravina K
• ICRI, Bangalore
Clinical Trial Supplies
Management
Place
Documentation details
LEAD TIME
GMP
Varies with Phases of CT
Quantity
Stability
Dispensing form
Place of manufacturing
Stocks
Blinding
Controlled clinical studies
Comparator
Placebo
Active
Test drug ( Different dosage/form)
Packaging
Selection w.r.t. stability data
Packaging of Comparator
Accountability
Patient compliance
Labeling
As per regulatory requirement
Blinding
Package – inner/outer
Language
Special instructions
Delivery of supplies
Shipment details
Tracking of dispatch
Global studies
Investigator’s Role
Accountability
Distribution to patients
Patient compliance
Disposal
Hospital pharmacy staff 1
Co-ordination with Investigator
Purpose of the trial
Description of the marketed product
Storage instructions
Numbers and recruitment parameters of
patients as trial participants
Randomization code
Hospital pharmacy staff 2
Medication List
C Shipment Request I
T V
Dispatch Request
S R
Shipment Receipt Notification S
M
Drug Dispensation
CTSM & IVRS - Data
elements
Medication details
Kit ID
Batch Number
Lot Number
Expiry Date
Consignment Details
Shipment ID
Sent Date
Receipt Date
.
Clinical Trials Supplies for Drugs
and Biologics -1
Prior to phase I:
• need product safety testing and basic
characterization information, cell bank
characterization