ICF
Document used to inform patients about their rights, the risks, & benefits of participating in a research study.
what is: informed consent form
Prior to handling any investigational product (receiving/dispensing/returning), one must have _____ in his/her hands
what is: red drug folder
Oh no your drug just experienced a temperature excursion! The first thing you should do is
What is: contact your manager
The amount of time to report if your patient experience a Serious Adverse Event
what is: 24 hours
The first place to become acquainted with a high-level overview of a new study.
what is informed consent form
The acronym is TASC, the meaning behind each letter is
What is: Time Ask Sign Copy
Once IP has arrived and has been properly checked in and logged on the drug log, where must the paperwork & drug log be uploaded
Where is: Basecamp Supplies Receipt
When IP has been exposed to unfavorable conditions, the IP must be
what is: quarantined
Your patient has experienced an SAE, the first thing you should do is populate the _______ to do list in ______
What is: "I have an SAE, now what?! & Basecamp
You should have your first _______ scheduled within one ______ of your site initiation visit
what is: screen & week
The location where ICFs can be found and printed on the day of the visit
What is: Drive
Prior to administering IP to a patient, the dispenser should always check these two things first
what are: temperature in range & kit unexpired
Prior to dispensing IP that has experienced an excursion, study personnel should obtain what first
what is: confirmation in WRITING
An adverse event is any _______ event associated with the use of an investigational product, regardless of whether or not it is related to the investigational product
What is: untoward
If the enrollment goal on a study is 10 and you currently have 4 patients enrolled, you should have a minimum of _____ patients scheduled
What is: 6
The document that outlines how informed consents are obtained is
What is: SOP (standard operating procedure)
Prior to handling IP and/or writing on a drug log, staff should be
what is: delegated
IP that has been quarantined should be placed in a separate bag with all of the paperwork surrounding the excursion and it should be stored in
What is: the same storage conditions required when in range (fridge/freezer/ambient - locked/limited access)
A delegated PI/SI must be the one to assess the _____ & _____ to investigational product for all adverse events
what is: severity & relatedness
When populating recruitment lists into RealTime call rosters for a new study, what patients should be prioritized?
What is: Past Study Patients (Low hanging fruit)
The subject must sign the informed consent prior to
What is: initiating any study related procedures
The IP receipt stamp includes steps that must be followed when IP is received at the site; those steps include
What is: stop temp tale, fax/return completed form, complete drug log, log in IVRS & print confirmation
The temperature for IP is documented in _____ & the ______ & _______ & ______ should be documented saily
What is: Drive, Minimum, Maximum, & Current temperatures
DocTrials documents PI oversight of Adverse Events & Serious Adverse Events by _______
What is: having the PI sign off on ALL subject AE/SAE at the time of the patient's exit visit
Recruiting subjects can be challenging; the primary ways to identify patients that we have found the most success are: _____, _____, _____, & ______
what are: RealTime (past study patients), doctor referrals, chart review, & community outreach