(Acronyms & Abbreviations)
AI/ML
What is Artificial Intelligence/Machine Learning?
An individual, company, institution, or organization responsible for the initiation, management, and/or financing of a research study.
Who is a Sponsor?
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?
ACRF
What is Annotated Case Report Form?
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
CD
What is a Controlled Document?
Research professional who develops new medications and/or prepares, compounds, dispenses research medications
Who is a Research/Investigative Drug Pharmacist?
A site's official storage of essential documents, including IRB approvals, protocol versions, investigator credentials, and monitoring log.
What is a regulatory binder?
Confirm CRF entries against original source records.
What is Source Data Verification (SDV)?
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?
They operate in controlled environments with continuous monitoring, focusing on adverse reactions and drug metabolism.
What is Phase I?
The term for OSF process of institutional review and authorization to conduct clinical trails in conjunction with appropriate IRB review/approval.
What is Research Administration/Institutional Permission?
Ensure the participant stops all study activities, notify the PI, and escalate the issue for resolution and documentation.
What is the immediate CRA response to an unsigned consent form?
BEM
What is Biotech, Enterprise, Moderna?
Research professional who ensures research adheres to all regulations, guidelines, and upkeeps the appropriate research documents
Who is a Clinical Research Regulatory Specialist/ Coordinator?
Department providing a service that is necessary to conduct a clinical trial protocol.
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?