There are 2 types of protocol deviations. Name either type.
Major or Lesser
100
Which of the following cooperative groups focus primarily on imaging?
(A) RTOG (B) GOG (C) ACRIN (D) ECOG
ACRIN
100
As of today, how many members of the CTO are there?
47
200
Which SOP must be given to a monitor at an SIV or a new monitor at the time of transition
A010
200
Name the statement of ethical principles of medical research involving human subjects that was adopted in 1964.
Declaration of Helsinki
200
Fox Chase Cancer Center has a table of major deviations (Q010) that lists deviations by specific category. Name 2 of the categories.
Informed Consent, Eligibility, Toxicity, Treatment, General Data Quality, Disease Outcome/Response
200
Who is the institutional PI of ECOG at Fox Chase?
Dr. Goldstein
200
Name 2 CTO employee who worked in the FCCC lab.
Laura, Gail, Jen, Terry, Nicole
300
Per SOP C012, name 3 types of contact that you must attempt prior to deeming a research participant in long term follow up lost to follow up?
Social Security Death Index, Local oncologist/Doctor, Certified letter, Legacy.com/obituary notice, Follow up letter
300
What is the least amount of members that must be on an IRB?
5
300
According to FCCC IRB policy, if a patient is not randomized/registered after ____ days of signing informed consent, the patient must be reconsented. Failure to reconsent is considered a major deviation.
30
300
Name the cooperative groups that Fox Chase is currently a main member of.
ECOG, GOG, RTOG
300
Which member of the QA team has worked at Fox Chase the longest?
Gail
400
According to SOP C061, what date is to be used as the off-study date in PTS?
The date when the treating physician decided to change the research participant's therapy despite possible on-going protocol required follow up.
400
What does FWA stand for?
Federal Wide Assurances
400
Once a major deviation is identified, the study team must submit a word document detailing the deviation. Who do you submit the word document to?
QA Director or designee
400
Which 3 cooperative groups are merging to form the Alliance for Clinical Trials in Oncology?
CALGB, NCCTG, ACOSOG
400
Name one of Linda Kish's previous employers.
Temple, RTOG, GOG, Travel business
500
What is the title of the SOP which requires the PI to sign off on all abnormal EKGs and record whether the abnormal result is clinically significant?
C046 Documentation and Assessment of Abnormal Study Parameters
500
Name the 3 ethical principles that constitutes the basis for the HHS human subjects regulations 45 CFR 46
Respect for persons, Benefiance, Justice
500
If a research participant is determined to be ineligible, whose responsibility is it to submit the major deviation?
Primary and Secondary reviewer
500
Which cooperative group started out with just doing pediatric oncology?