Clinical Research
What does “PI” stand for in a research study?
Principal Investigator
What is the inclusion criteria for the Behavioral Registry (CAP)
18+ and SI patient
What does HIV stand for?
Human Immunodeficiency Virus
What does IRB stand for?
Institutional Review Board
Name two teammates on our team that have children?
Johnny, Ali, Ivon, Maibe, Patricia
What document must participants sign before joining a study?
Informed Consent Form
Name 4 studies we are recruiting for
Path,Less is More, Trident, CannHeart Dime Mas, StepAD, ADELANTE, HIBRID, MIND, CANDIE, HIV & Pain, PSINAPSE, INSTACARE, SUSTAIN, ARES, TAI CHI, APPROACH
What type of cells does HIV primarily attack in the immune system?
CD4 T cells / helper T cells
What is the IRB’s main purpose?
To protect the rights and welfare of human research subjects
What is Sandra's middle name?
Eugene
Give three examples of PHI that must be kept confidential in research
Name, DOB, MRN, Address, email address, photo, phone number, social security number, IP Address, license number
Name two current or past studies from our team that involved MRI scans
PATH, LAART, Herbal Brain, CSVD, OPIS, 30-day Challenge
What is the difference between HIV and AIDS?
HIV is the virus; AIDS is the advanced stage of infection when the immune system is severely weakened
A participant withdraws from the study. Can you still use the data already collected?
yes, data collected up to the point of withdrawal can usually be retained, unless the participant requests otherwise
Name 4 former members of our team
Roger, Jaislene, Jackie, Nicho, Jessica, Lavarr, Greg, Frankie....
When study procedures are not followed exactly as approved in the protocol, such as missing a required lab test or enrolling an ineligible participant
Protocol Deviation
What is the purpose of the OPIS study?
to see how opioids affect the immune system in people living with HIV
What is an undetectable viral load
unde 20 or under 200
Before working on a study, what trainings must every coordinator complete
Good clinical practice, Human Research Subjects
Name one of the two teammates who celebrate their birthday in January
Danielle or Yoibel
How long do you typically have to report a serious adverse event to the sponsor or IRB?
within 24 hours
How often do CNICS participants get to complete a PRO
Every clinic visit, every 3~4 months
Name two long-acting injectable antiretroviral medications currently approved for HIV treatment?
Cavenuva, lenacapavir (Sunlenca)
A PI wants to change the blood draw volume in the study. What must be done before you implement it?
submit an amendment to the IRB and receive approval
What is Valeria's hometown in Colombia called?
Manizales