Employees are required to read, review, and complete a comprehensive quiz on 29 Standard Operating Procedures annually. A passing score of 80% or better is required to pass. This quiz is presented open-book style.
Great Clinical Points
General Clinic Practice
Global Carbon Project
Good Clinical Practice
Adverse Event
Side Effect
Unexpected Adverse Event
Serious Adverse Event
True
False
Maintaining SOPs that meet or exceed FDA regulations and GCP Guidelines
Maintains all test articles, including investigational product and subject records
Ensuring all study activites are performed correctly
Ensuring every staff member has had training on taking blood presssures
Ensuring that each coordinator has been trained on research SOPs
Ensuring source documents are signed in a timely manner
Principal Investigator, if he's an MD or DO
RN
PharmD
Principal Investigator, if he's a Doctor of Chiropractic
LVN
SubInvestigator, if he's an MD or DO
UAP (Unlicensed Assistive Personnel)
True
False
Someone who has been a nurse for 20 years, but no research experience
Someone who is not a nurse, but has 3 years experience coordinating studies in phase I-IV
A newly hired recruiter with no coordinating experience
A medically trained person who says they can coordinate clinical trials
The subject's responsibilities
The clinical trial is non-invasive
A statement of indemnification of the physician investigator
The guarantee that the subject will receive active drug
True
False
That all site personnel wear navy blue scrubs
That the site has qualified study personnel without sufficient time, knowledge, and experience to conduct the study
That the site has access to an adequate number of potential study subjects that would meet study criteria
That all site personnel have had experience with FDA audits
True
False
True
False
The color of the ink used to record entries
The presence of the most current ICF, sign appropriately by all required parties
The date in which the visit was done
The data written on a sticky note, but attached to a memo-to-file explanation
Advertisements
Enticing a reluctant student into participation with promises of 'Big Cash'
Posters
Leading a homeless person to the office with offers of 'free medicine'
Use of EMR for patients who've agreed to be contacted
All medications, monitor documentation
Lab certification, clia waiver
Source data, IRB closeout letter
All documents, IRB approval
Site initiation visit
Ongoing study visit
Close-out visit
Holiday lunch
Telephone conversations
Ensure all CRFs are complete, all source is complete
Prepare the study closure report for the IRB
Pack the unused & returned drug for long-term storage with the source documents
Ensure the safety & data reports are complete with the help of the CRA
True
False
True
False
Not taking a subject's blood pressure, but writing a blood pressure in the source
Not taking a subject's blood pressure, but writing a note in the source that it was 'inadvertantly missed'
Signing someone else's name on a delegation log
Taking a subject's study drug upon return, but keeping it for oneself and documenting it was taken by the subject
Retaking an EKG repeatedly until measurements 'fit' the criteria
Retaking an EKG once to 'verify' the reading, but calling the sponsor for guidance
True
False
Tim, the IT Guy
Office Manager
PI
Coordinator
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