Regulatory
How long do study records need to be kept?
25 years
What temperature range does a study fridge need to be maintained at?
2 degrees Celsius to 8 degrees Celsius
Can we dispense commercial supply if there is no study stock available?
No
How do you know if an oncology patient is on study?
On the order, Centricity, Powerchart, and drug accountability binder (DAB)
What is the telephone extension to reach research pharmacist.
2955
How often do you need to renew your Good Clinical Practice (GCP) and Health Canada Division 5?
Every 3 years
How many sections are in the Work Instructions?
A. 7
B. 8
C. 9
D. 10
D. 10
WI 01 Research Training
WI 02 Protocol Activation
WI 03 Ordering IP
WI 04 Receiving of IP
WI 05 Storage of IP
WI 06 Dispensing of IP
WI 07 Return and Destruction of IP
WI 08 Documentation and Accountability of IP
WI 09 Study Close-out
WI 10 Audits and Inspections
Outside of oncology/hematology, name a clinical area we work with.
Slide 5
What is the first question, pertaining to training, you should ask yourself when you receive an order on the queue for a patient that is enrolled on study?
Am I study trained?
What are the names of Erin's two cats?
Dobby and Tofu
Identify two Good Clinical Practice (GCP) issues on this worksheet.
Slide 2
Which folder on the Pharmacy Teamsite is the online version of the Pharmacy Research Work Instructions located in?
Pharmacy Research folder
Outside of dispensing, name a study task we perform.
Slide 6
Number of active oncology/hematology studies with a drug accountability binder (DAB)
A. 10
B. 16
C. 24
D. 30
C. 24
What is the name of the choir Lisa is involved in?
Who may come and perform a study audit?
Study sponsor, Health Canada, U.S. Food and Drug Administration, internal audits, College of Pharmacists of BC, C17 Council
What do you do if you are contacted about a temperature alarm during evenings/weekends?
Refer to Work Instructions. Manually check temperature logger. Notify Research Pharmacist. If >1 hr, move stock to alternate location. If in doubt, call for help.
What is a delegation log?
Gives the individual the authority to perform a task listed under the delegation log, with the Principal Investigator overseeing the action.
Ex. counselling, dispensing of study drug
Arrange the following in sequential order to describe how an IV oncology study drug order gets processed:
A. Pharmacy Technician preps, compounds, and checks final product
B. O pharmacist enters order and checks Current Oncology List to determine if study specific worksheet required
C. Order written by clinical pharmacist cosigned by physician
D. Float pharmacist checks order and double checks Current Oncology List
Slide 7
Erin is a co-author of a study we are involved in, what is the study?
Study #1. Title: Folic acid supplementation in children with sickle cell disease: study protocol for a double-blind randomized cross-over trial
Authors: Brock A. Williams, Heather McCartney, Erin Adams, Angela M. Devlin, Joel Singer, Suzanne Vercauteren, John K. Wu and Crystal D. Karakochuk
Study #2. Erin is also a co-investigator for the "Efficacy of Gabapentin in Treating Pain in Children with Severe Neurological Impairment" study
Can study documentation be backdated?
No, BUT omissions do happen so it can be added as a late entry with a record of the date when it was documented.
What exciting change is research pharmacy expecting, pertaining to the storage of study medications?
A. Extra shelf storage in T8 satellite
B. Temperature monitor system update
C. New location for storage of study medications other than in T8 satellite
B. Temperature monitor system update
How many active non-oncology studies are we involved in?
A. 23
B. 32
C. 56
D. 71
C. 56
What is the name of the group where most of our oncology study protocols come from?
Children's Oncology Group (COG)
Each Research Pharmacist had an opportunity to travel outside of the country for study training. Name a research pharmacist and the city they visited for study training.
Erin - Boston
Lawrence - Los Angeles
Lisa - Dallas