Clinical Study Report - Calidad de Información CFR

9.4.2.3. Management of investigational product
The pharmacist in charge of investigational drugs took the responsibility for receiving, storing,
preparing, taking care of and returning the drugs.
The pharmacists made sure of receiving study drug, double-checked number of the drugs
received on an invoice, signed the invoice, and took good care of the drug. He/she assured that
the investigational drug was administered to eligible subjects per protocol only and kept a
correct record of study drug given and managed. Unused investigational drugs should be kept
until the sponsor makes a decision on discarding or collecting them. Managing pharmacists
submited a copy of the record on all the unused drug, used/unused vials, labels, and drug
management to the clinical trial monitor.
9.4.3. Methd of assigning patients to treatment groups
(1) A randomization list was made using a block randomization method. To create a 4:3
allocation ratio between the treatment and control group, a block of size 7 was used for
each center. The size of the block was not specified in the protocol or known to
investigators.
(2) Procedure
When an eligible patient satisfying the inclusion/exclusion criteria was registered, the
investigator filled up a request form for randomization allocation, faxed the form to Lifecord
Stat-Korea (LSK), and called to ask whether the staff in charge of randomization allocation
had received the request form. The staff at LSK wrote a randomization code, faxed the form
back to the investigator, and called to confirm the randomization.
Or the investigator called the LSK staff in charge of randomization allocation. The LSK staff
gave the investigator the randomization code immediately. The investigator confirmed the
randomization code by submitting the randomization request form to LSK via fax and
making a call to the LSK staff. The LSK staff checked request form and signed and sent the
form, back to the investigator via fax. The LSK staff confirmed whether the investigator had
received the signed form.
Both LSK staff in charge of randomization allocation and investigator kept a copy of the
completed randomization request form (Details are shown in Appendix 16.1.6).
Staff in charge in randomization allocation:
Lifecord Stat-Korea(LSK)
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