(Acronyms & Abbreviations)
AI/ML
What is Artificial Intelligence/Machine Learning?
Research professional who ensures research adheres to all regulations, guidelines, and upkeeps the appropriate research documents
Who is a Clinical Research Regulatory Specialist/ Coordinator?
Comprehensive, detailed plan or "living document" that outlines the entire rationale, design, methodology, and ethical considerations of a research study.
What is a research protocol?
The signed and dated document that allows a covered entity to use and/or disclose PHI for research purposes.
What is HIPAA Authorization?
The date of Clinical Trials Day
What is May 20?
ERDs
What is Ethical and Religious Directives for Catholic Health Care Services?
Research professional who manages the day-to-day activities of a clinical trial
Who is a Clinical Research Coordinator?
The process that ensures a participant receives and sufficiently comprehends information in order to decide and communicate voluntary participation in research
What is the informed consent process?
The entity responsible for review and approval of protocols to ensure ethical conduct of human subject research.
What is the Institutional Review Board (IRB)?
James Lind
CA
What is a Coverage Analysis?
Research professional who develops new medications and/or prepares, compounds, dispenses research medications
Who is a Research/Investigative Drug Pharmacist?
Often called "bench-to-bedside," this type of research accelerates the transformation of basic scientific discoveries into practical, clinical applications—such as diagnostics, therapeutics, and medical procedures—to improve human health
What is translational research?
The appropriate documentation that establishes the regulatory review relationship between a research site institution and a single/central IRB
What is a reliance agreement OR IRB Authorization Agreement?
The disease that was investigated during the first randomized clinical trial
What is scurvy?
REDCap
What is Research Electronic Data Capture?
Research professional who designs, analyzes, and interprets data from clinical research studies, contributing to advancements in patient care and treatment
Who is a Biostatistician?
A framework for establishing and maintaining data integrity comprising the qualities of Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
What is ALCOA+?
The term for OSF process of institutional review and authorization to conduct clinical trials in conjunction with appropriate IRB review/approval.
What is Research Administration/Institutional Permission?
True or False: Clinical Trials Day is an international commemoration
What is true?
SUSAR
What is Suspected Unexpected Serious Adverse Reaction?
An individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed.
Who is a Sponsor-Investigator?
Department providing a service that is necessary to conduct a clinical trial protocol: Pharmacy, for example
What is an ancillary department?
When personal financial or institutional interests potentially or actually interfere with the primary interests of research integrity and participant well-being.
What is a conflict of interest?
To recognize the impact of clinical research on medical progress, celebrate clinical research professionals, and thank participants for their contribution to developing new, safe, and effective treatments
What is the purpose of International Clinical Trials Day?