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Pharmacist's Tasks in Clinical Trials

7th Master Class in Oncology Pharmacy, Dresden 2013
by

Wilfried Büchler

on 23 October 2013

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Transcript of Pharmacist's Tasks in Clinical Trials

Pharmacy Binder
Trial ABC 007
The Oncology
Pharmacist's Tasks
in Clinical Trials

The Workflow,
The Dos and Don'ts

Preparation and/or dispensing
Restocking of IMPs
Different ordering practices possible:
Automatically according to data in IXRS
Actively by the pharmacist
IXRS
Fax-form
Mail or telephone-call to the CRA
...
Tasks after Initiation Visit
Write the respective SOP
Create the protocol in the planning and preparation software
Activation of IVRS/IWRS
Patient data
...
Name of the clinical trial
Name and dosing of the IMP
If required further CT specific data
(e.g. arm, medication number, ...)
Signature of the investigator (PI or Co-/Sub-Investigator according to Site Signature Log)
Prestudy Visit
Participation of pharmacist highly recommended
First presentation of the clinical trial
First possibility to get information and to ask questions
Sometimes even possibility to exert influence on the accountability sheets and even on the protocol, ...
Initiation Visit
First contact with monitor/CRA
Presentation of the clinical trial
Pharmacy binder
Site Signature Log
CV
Several other documents
IVRS/IWRS access data (envelope)
Provide information to the sponsor
Gather information (ask, ask, ask!)
Set the stages
Shipment of CT medication
Prescription
Meet the investigator
and his team
Principal
Investigator
(PI)
Co-
Investigator
(Sub-
Investigator)
Study
Coordinator
Study
Nurse
Clinical
Trial
Pharmacist
Make familiar
with GCP
Read the Guideline for Good Clinical Practice E 6 (R1)
Set up storage conditions for Investigational Medicinal Products (IMPs)
separated from other medications
restricted access
temperature monitoring with records
separate lockable refrigerator
lockable cabinet for storage at room temperature
(deep freezer)
Sponsor
CRO
Contract Research Organisation
CRA
Clinical Research Associate
if applicable get medication number via IVRS/IWRS
lock in of the IMP to the preparation room
Labelling
has to be marked as „clinical trial medication“
if applicable enter data of current visit into IWRS
keep empty outer packing for CT-monitor-check?
blinding
garbling name of medication and/or dose
fictitious dose and batch-number for placebo
non-transparent cover for the bottle or bag
Adherence-check for oral medication
Count the tablets …
Compare with calculated account
if applicable compare with patient diary
keep returned tablets, blisters and cartons (also empty ones!) for monitor-check
Accountability
Monitoring Visit
CT monitor (CRA) checks data in the drug accountability log
If applicable release for disposal or initiation of reshipment of IMPs which are expired or which are not used anymore
If applicable release for used and stored IMPs
Documentation in the Monitoring Visit Log
Disposal
or return
to the sponsor
Read the Guideline for Good Clinical Practice E 6 (R1)
Close-Out-Visit
Check study binder for completeness
Documentation in the Monitoring Visit Log
Archiving
Keep records for 15 years
avoid to keep
used vials!
Full transcript