Got the 'ICH'
According to Principles of ICH GCP, What should be obtained from every subject prior to clinical trial participation?
Freely given informed consent
As ICON employees, we are automatically provided with Executive Status with this rental car company.
National
What happens when you select 'Start Visit' in CTMS2go?
The visit changes from scheduled to actual in IcoTrial.
When reviewing the IP accountability log, you notice there are site staff initials missing for drug dispensation. This entry is not ALCOA+ compliant because it is not _____.
Attributable
Headquartered in Manhattan, this sponsor grossed over $100.3 BILLION in revenue in 2022.
Pfizer
According to ICH GCP where would you routinely find a description of - Actions taken or to be taken and/or actions recommended to secure compliance?
Monitoring Visit Report
If you reach the elite 360 Medallion tier with Delta and have a tight connection, an airline representative may pick you up in this luxury vehicle and rush you to your gate.
Porsche
What can you see on the 'My Visit' screen?
View scheduled, in-progress, and completed visits.
Your favorite study coordinator makes an error while completing source documentation. In order to correct this, she attacks the page with black sharpie, completely covering the original entry. This is a violation of which ALCOA+ principle?
L- Legible
The company’s name actually comes from the founder’s wife, Alice La Roche. Swiss married couples use both family names, and the company’s name was shortened to ____ decades ago.
Roche
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often?
At intervals appropriate to the degree of risk to human subjects, but at least once a year.
The JW Marriott brand was established in 1984, with the opening of the first hotel in ______.
Washington, D.C.
True or False: You can use CTMS2go even when offline.
-Start a visit
-Finish a visit
-Edit a visit
-Resolve a site action
When you are back online, CTMS2go will attempt to sync the data with IcoTrial.
When reviewing source, you notice that sticky notes with vitals are included with the site source documentation. You thank your study coordinator for complying with this ALCOA+ principle, because they retained source that is _____.
O- Original
While this company may be best known for consumer health items such as baby powder and shampoo, they successfully developed and marketed a popular, vector-based COVID vaccine in 2021.
Johnson and Johnson
According to ICH GCP for how long the IRB/IEC should retain all relevant records?
For at least 3 years following completion of the trial.
How often do aircrafts land or take off at Chicago O’Hare International Airport?
1. Every 37 seconds
Can you use CTMS2go to reschedule a visit?
No. You cannot reschedule a visit by setting a new planned start or end date. This must be done in IcoTrial.
If you've ever relied on Advil to cure a headache, you have this British pharmaceutical company to thank. They are credited with developing and marketing the famous drug, along with Centrum and Theraflu.
GSK
Which of the following is a principle of ICH GCP?
a. Clinical trials should not be conducted if there are any foreseeable risks or inconveniences to trial subjects.
b. The medical care given to subjects should always be the responsibility of a qualified monitor assigned by the sponsor.
c. Clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
d. Individuals involved in conducting clinical trials should be qualified by their ability to adhere to ICH GCP.
c. Clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
In USD, how much are 100,000 American Express points worth?
$670
You cannot edit a visit in CTMS2go when the status is listed as '______'.
Completed
What are the FOUR principles that make up the '+' component of ALCOA+?
The acronym 'ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate. In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Founded back in 1661 as a morphine distributor, this large pharma company is the oldest in the world.
Merk & Co