Word Up!
This "V" word means that a person in a research study decided to take part in the study because they wanted to, not because someone made them.
What is Volunteer?
A research study with human subjects.
What is a clinical research trial?
These 13 principles set an ethical scientific and practical standard for clinical research
What is Good Clinical Practice
This is a system used to record data electronically for clinical trial participants.
What is an electronic data capture system (EDC)
This person conducts visits to confirm site compliance with the protocol and data entry.
Who is a CRA/monitor
This "P" word is sometimes used in clinical trials and has no effect or treatment, but is important to compare active treatments to.
What is Placebo?
The process of ensuring that a research subject understands all aspects of the research study prior to volunteering to participate.
What is Informed Consent?
If this wasn't done, it didn't happen
What is Documentation
This ebinder houses all regulatory and study participant source documentation not available in Epic.
What is eFlorence
This person is responsible for scheduling and setting up monitor visits?
Who is a Data Coordinator
This "B" word means that you do not know what treatment or medication you are receiving in a research study, and sometimes neither does the study doctor.
What is Blinded?
This person performs study-related procedures. They work directly with patients to consent potential participants, assisting with participant visits, collect data, and administering treatments.
Who is the study coordinator (ACRC/CRC)
Redaction of this type of information is needed to protect patient privacy
What is Protected Health Information (PHI)
This system contains tabs including: Notes, Results Review, Document Viewer, Meds.
What is Epic
A monitor can be referred to these resources for site monitoring frequency and duration.
What are Directives/Contract
In research, these people help protect research participants by reviewing and approving research at institutions before it can begin. Its initials are "IRB".
Who is the Institutional Review Board?
This is an undesirable experience that occurs during the clinical trial
What is an adverse event
In order to be granted access to research systems for a study, you must complete this form to confirm there is no conflict of interest
What is a Financial Disclosure
Data Coordinators utilize this system to identify who is on the study roster, any protocol or consent amendment approvals, modifications, and more.
What is the IRBe
These are the 3 systems that a monitor needs access to conduct the visit
What are: Epic Care Link (ECL), eFlorence, and Vestigo
This "R" word means that a research subject is assigned to a research study group completely by chance, either by a computer-generated number or other mechanism.
What is Randomization?
The main goal of the IRB
What is ensure the protection of the study participants?
I see this: Participant signs the informed consent before the Clinical Research Coordinator. Ethical or unethical?
What is Ethical
This system is where you go to upload de-identified images
What is AMBRA
These entities employ monitors/CRA
Who is the Clinical Research Organization or Sponsor