DMPs and Work
Instructions
Instructions
Adverse Events
Who You Gonna Call???
(or email)
(or email)
Ada
Protocol
100
Under which drive can all DMPs and Work Instructions be found?
Scruffy (R:)
100
Name the 3 individuals who work on the AE Team?
Rich Foster, Michelle Burns, and Briana Fuertes
100
You would like to request some time off next week, who should you ask about the request?
Your PC? (or Supervisor)
100
You have created a file in ada and after submitting the file you are prompted with a message stating you do not own the file created to this study. Who should you contact to give you study access for Ada?
Rick Magnan
200
Per the RAVE work instructions, what does the following symbol mean?
Non-Conformant Data
200
The expected adverse events for a specific study can be found under this list, located in section 5 of the protocol?
The SPEER
Specific Protocol Exceptions to Expedited Reporting
200
You just moved to a new apartment downtown and need a new T Pass, who should you contact?
BillieSue
200
You are look for a patients survival status. What command should be used to look it up?
xpat study patient#
200
Eligibility can be found in what section of the protocol?
Section 3
300
The RAVE Study Work Instructions state that before inactivating a form the DM should have the site do what to the form?
Delete any data still on the form
300
What are the 5 attributions that an Adverse Event can be labeled as?
Unrelated, Unlikely, Possible, Probable, Definite
300
A site has called with a question in regard to OPEN and you do not know the answer, who should you contact?
The Registration Team
Carol Chami, Juanita Andrews, and Ellen Lovett
300
To list CTEP-AERS tickets that have been submitted for a patient what command should be used?
adr study patient#
300
Under what section of the protocol can the reporting requirements for serious adverse events be found?
Section 5
400
Per the Work Instructions for Internal Forms, additional documentations such as email chances confirming eligibility or confirmation of patient transfer should be uploaded where?
The Internal Communications Form
400
A site has reported a Grade 3 Hypertension and a Grade 4 Hypertension in the same cycle, and both grades are reportable via CTEP-AERS. However, only one can be reported on the ticket. Which do you report?
The highest grade (Grade 4 Hypertension)
400
A site has called about specimen submission, and the lab team is out to lunch. What email address should you write to?
ecog.tst@jimmy.harvard.edu
400
A patient has been reported as a "No Start Treatment" and is in need of being canceled in ada. This will need to be updated in aaconf. What is the starting command used to make this change in aaconf?
correct
400
A site calls and states that they have been following a patient for 10 years and asks if they should keep following their patient. Where in the protocol can you find out the duration of follow-up?
Section 5
500
Per the work instructions, in order for a patient to be deemed Lost to Follow-Up, how many different attempts of contact must be made and for how many years must there be no successful contact?
3 different contact strategies and 2 years of unsuccessful contact
500
A grade 5 event has been reported in RAVE, the patient last received protocol agent 2 months ago and the event is unrelated. Should this event be reported via CTEP-AERS?
No
500
A site has called with a medical related question that is not specified within the protocol. Who should be contacted?
The Study Chair!
500
What are the 4 types of files that should be moved into your created folders in Ada?
.ctt
.out
.adr
.cor
500
Protocols states that all questions in regards to the Investigator Brochure, Drug Accountability, and Drug Returns should be directed to the PMB. What does PMB stand for?
Pharmaceutical Management Branch