Play Specific
Where should paper questionnaires, like a C-SSRS, be filed in a participant folder?
What is the source documents tab.
Per SOP-7951(Cardiac procedures)- Participants are requested to remove what clothing item(s)?
What is request …to remove bras and nylons/tights, as appropriate.
Per SOP-7949, If not specified by the protocol, what questions should participants be asked to determine if they are experiencing any AEs?
What is non-leading.
From which three words was the name Fortrea derived?
What are Forward, Trial, Ease.
What item should be applied to participants who will no longer receive a dose(s).
What is a black wristband.
True or false, the lights can be dimmed or off when conducting any procedures?
What is False.
Per SOP-7946 (Trial Participant Check-In and Check-Out Procedures) a participant’s ID should be verified for subsequent check-ins using what?
What is the picture on file stored under the ‘subject data tab’.
E6(R3) terminology refers to the updated language in the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guideline, which includes replacing "subject" with …
What is Trial participant.
If you need to reference an SOP such as SOP-7977 describing how to QC certain documents, what linked SharePoint site could you reference?
Veeva Vault
Per SOP-7949, list the team members that should be notified when dosing is interrupted/discontinued by an investigator?
What is the CRC, OC, Pharmacy and Sponsor.
Any time when conducting a procedure on a participant, you should first check this…
What is the participants identifier.
Per SOP-7952, when the protocol indicates a scheduled time for each participant’s meal, what is not an acceptable first bite or drink?
What is water.
This fundamental document must be QC’d and filed in a participant’s chart in real time.
What is a consent form.
What core principle is defined as “I hold myself accountable and work across perceived boundaries to find solutions and deliver.”
What is Own It.
Name one of two reference activities that require the seconds of the field of time to be adjusted to 00 (“Zero-Zero”)
What is Dosing or Consenting.
When QC-ing laboratory requisitions, the transcribed blood draw time must be verified by time on the blood draw source document.
What is true.
Per SOP-7949, When possible, where should discussion regarding AEs be conducted?
What is a private setting, away from other subjects.
ALCOA is a technique that can help ensure paper and electronic data are compliant with FDA Regulations and Guidance. What does the acronym ALCOA stand for?
What is Attributable, Legible, Contemporaneous, Original, Accurate.
Name the “Fortrea FOUR” core culture principles.
What are Uphold Integrity, Forward Together, Respect People, and Own it.
This important document is used to give instructions to the dose and dose verifier on how to administer the investigational product, as well as give pre-dose, and post-dose restrictions.
What are dosing instructions.
An erroneous practice where data captured on a previous date is documented as such and not noted as a late entry…
What is backdating.
Per SOP-7976, “Good Record Keeping Practices,” when transcribing downtime source into the BDC, how do you document that transcription of data was completed
What is “transcribed by,” initials and date.
The first controlled clinical trial is often attributed to whom? (Hint: Scurvy in 1747)
Who is James Lind
As part of the offsite evaluation checklist, a participant should be requested to sign a what, if situation and time permits, before transfer?
What is the Confidential Release/Request of Information Form (RA-AD-111-001)
Per SOP-7971, the dose/dose verifier, responsible for verifying the right dose, right participant, right drug, right route and right time, is defined as the…
What are the five rights of medication administration.