GCP
This is required prior to performing any clinical trial procedures.
What is Informed Consent?
Although not a federal regulation, consent forms should be written at or below this grade level.
What is 8th grade?
HSERRACE
What is Research?
This is the minimum number of members needed for a valid board.
What is five?
ALCOA
What is:
Attributable/Legible/Contemporaneous/
Original/Accurate?
Committee that reviews proposals to ensure the ethical treatment of participants
What is the Institutional Review Board?
Each participant in a clinical trial has an equal and independent chance of being selected to a study arm.
What is randomization?
UEOCRS
CODSENUTM
What are Source Documents?
IRB approval required prior to expiration of initial approval date
What is Continuing Renewal or Review?
What is Data Safety Monitoring Board?
Clinical researchers may not conduct research involving human subjects without this.
What is IRB Approval?
This is considered to be the first step of the informed consent process which is why it requires IRB approval.
What is advertising?
ITIFCLYDTEAONOIN
What is confidentiality?
Any untoward medical occurrence that occurs during the course of the study
What is an Adverse Event?
OHRP
What is Office for Human Research Protections?
Document used to guide the actual conduct of the study from start to finish.
What is the protocol?
The ICF may NOT contain this type of language that appears to waive a subject’s legal rights
What is exculpatory?
LIDAVANOIT
What is Validation?
Departure from the IRB approved study protocol
What is a Protocol Deviation?
HIPAA
What is Health Insurance Portability and Accountability Act?
The ICF must be signed by these individuals.
What are the participant (or subject) and the person obtaining consent?
Pregnant women, children, and prisoners are identified by this term
What are vulnerable populations?
MTEUTEIRCNR
What is Recruitment?
At WFUSM, ALL of these must be reported to the IRB regardless of the funding source
What are Breaches of Confidentiality?
What is the Collaborative Institutional Training Initiative?