ICF Refresher
The ICF must note that this government agency may inspect the participant's records
What is the FDA
We didn't know this person in high school, but their nickname was "Dubes", perhaps this lead to their perpetual calm demeanor
Who is Deb
This staff member seems reserved but feels very strongly about their dog and named him GRAPE! (yes, exclamation point is part of the name)
Who is Geoff
In between listening to K-pop bands and finding our mistakes in PennChart, they dabble in professional video-gaming
Who is Jen
The person with overall responsibility of the clinical trial at a site
What is the Principal Investigator
This report states "coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance"
What is The Belmont Report
When not shopping for fancy kicks, they love vacationing at the Amalfi Coast
extra point: # of pairs of shoes
Who is Chris
200!!
This addition to our team loves warm days and park naps, be sure to give a nudge if you see them "resting their eyes" on a campus bench near the School of Nursing
Who is Stephen
When this person was pregnant and serving in the armed forces, the 40th president touched her belly
who is this person?
who was the president?
which branch did she serve?
Dana
Reagan
Air Force
A set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
What is the Declaration of Helsinki
A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document as long as this also occurs....
What is An impartial third party should witness the entire consent process and sign the consent document
When their rap career wasn't covering all of their daughter's softball expenses, they joined our team, tackled Study Hub and never looked back
Who is Nikki
This quiet but fierce team member spends weekends brewing their own beer, in between QAing research visit encounters
Who is Petra
They might be quiet as a mouse while at work, but this person is known to sing loudly while riding their scooter to the office
Who is Alice
This guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions
what is the International Conference on Harmonization (ICH)
In July 2017, the PA Supreme Court mandated that an MD/APP must review these ICF sections with all participants and assess their understanding prior to the administration of the investigational product
What are Risks, Benefits, Alternatives
Changes abound! New apartment, less hair, but one thing remains the same- their affection for Pumpkin the cat
Who is Catherine
If you are going to travel to Scotland and visit the castles, be sure to consult with this team member who loves studying 15th century Alba (Gaelic for Scotland), but catch them while they are here on Mondays and Thursdays
Who is Megan
This person may be the reason KFC dropped the "finger lickin good" slogan during the pandemic, they have a personal connection to Colonel Sanders
Who is Dave
Compliance with this standard assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible
What is Good Clinical Practice (GCP)
The FDA requires all clinical trials are listed on this website which is publicly available and contains study descriptions, sites conducting the study and contact information for each site
What is www.clinicaltrials.gov
Nothing can sway the attention to detail of this one who can cite GCP guidelines, Title 21 CFR part 11 requirements and arranges their closets coordinating colored hangers with color of clothes
Who is Ro
Their alma mater's mascot in the 70s was an Indian, later found to be inappropriate and removed leaving students with the nickname The Big Green (referring to the beautiful green college quad in Hanover, NH)
Team member?
School?
Who is Ian
extra point: What is Dartmouth
With one near-sighted eye and one far-sighted eye, this person definitely enhances the "vision" for our unit and looks outside of the box when it comes to recruiting
Who is Diego
Any untoward medical occurrence that at any dose: (A) results in death (B) is life threatening (C) requires inpatient hospitalization or prolongation of existing hospitalization (D) results in persistent or significant incapacity (E) is a congenital anomaly/birth defect
What is a Serious Adverse Event (SAE)