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IRB
ICF
People of Vistakon
Regulation
GCP
100
A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.
What is an IRB
100
An IRB approved legal document to ensure that a subject knows all of the rights, risks and benefits of a research study
What is an Informed Consent Form?
100
Lives life on the edge by snorkeling with Sharks - Twice! Skydiving - Twice! And competes in Canine Agility Training Hint: Has presented many, many topics today
Who is Margaret Balsamo, CRA Feasibility & Pivotal Studies
100
The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
What is Part 11 - Electronic Records; Electronic Signatures?
100
An International Ethical and Scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
What is the definition of Good Clinical Practice?
200
A procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB.
What is an Expedited Review?
200
A child's affirmative agreement to participate in a clinical investigation
What is an Assent?
200
Lays awake at night concerned about Lens Accountability and is a HUGE Soccer FANATIC - No Bigger Fan for England's very own Manchester United Hint: Inspection Readiness
Who is Berkley Pollard, Director of Quality Assurance?
200
I will conduct this investigation in accordance with this agreement, the protocol, conditions imposed by the Institutional Review Board and the FDA (21 CFR, Part 5056). I will comply with all requirements regarding obligations of clinical investigators as set forth by the FDA (21 CFR, Part 812).
What is the Statement of Investigator Agreement?
200
The act of overseeig the progress of a clincial trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirements. GCP 1.38
What is a Monitor?
300
An Individual who is or becomes a participant in research
What is a Human Subject?
300
Enacted by the US Congress in 1996 protects health insurance coverage for workers and their families when they change or lose their jobs
What is HIPAA?
300
Sticking to their Southern Roots - Loves Pork Skins, Boiled Peanuts and Professional Bull Riding Hint: Pregnant
Who is Dia Dooley, CRA Pivotal Studies
300
Bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.
What is The International Conference on Harmonisation
300
Original documents, data, and records (eg hospital records, clinical and office charts, laboratory notes, memoranda, subject diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, etc.) GCP 1.52
What are Source Documents?
400
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What is Minimal Risk?
400
The subject was able to give voluntary Informed Consent and Agreed to comply with the study protocol. Ample time was given to review the informed Consent and all questions were answered satisfactorily. Consent was obtained prior to any study related procedures being conducted and a signed/dated copy was given to the subject.
What is the Informed Consent Process?
400
In their "spare time" Creates Beautiful Beaded Jewlery and recently adopted a Pound Puppy Hint: Welcomed you to today's meeting
Who is Jeanne Stevens-Crowe, Manager of Clinical Affairs
400
To be considered eligible to participate in the clincial study investigation, each subject must meet the following requirements
What is Inclusion Criteria?
400
Any untoward medical occurence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. GCP 1.50
What is a Serious Adverse Event (SAE)
500
Protocol, ICF, Patient Handouts, Advertisements, Questionnaires, Investigator Brochures...
What requires IRB approval?
500
An individual who actually conducts a clinical investigation i.e. under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team
What is an Investigator?
500
Proud Mom of a Marine & an Eagle Scout Hint: Presented the Do's & Don'ts of Supplies with Mr. Magoo
Who is Cynthia Marsh, Project Manager Feasibility Studies
500
Responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation
What is The Food & Drug Administration
500
The three fundamental ethical principles for using any human subjects for research are 1. Respect for persons 2. Beneficence 3. Justice
What is The Belmont Report