Abbreviations
MPV
What is Mean Platelet Volume?
Document that lists which tasks staff are allowed to perform.
What is the Delegation of Authority (DOA)?
Phase of trial conducted post-marketing.
What is Phase IV?
Document that lists the common names for adverse events.
What is the Common Terminology Criteria for Adverse Events (CTCAE)?
What is Protected health information (PHI)?
BUN
What is Blood Urea Nitrogen?
Document that investigators complete that lists any monetary incentives they receive in association with a study.
What is a Financial Disclosure Form (FDF)?
Location of the most recent/current Medwatch form.
What is the FDA website?
The process of generating detailed instructions for a language model to execute.
What is prompt engineering?
WOCBP
What is Women of Child-Bearing Potential?
Document that serves as the primary source for risk information for a drug.
What is the package insert (PI) or Investigator Brochure (IB)?
Version of Medwatch form used for ISTs.
What is Medwatch Form 3500a?
System used by FCCC to create RECIST reports.
What is the MINT system?
AI that is offered to FCCC through Microsoft Edge.
What is CoPilot?
t.i.d
What is three times daily?
Certification that is required for every person on the DOA.
What is CITI GCP Certification?
Form that is signed by the principal investigator in which they agree to conduct the research in compliance with FDA regulations.
Survey creation tool, sometimes used as an EDC.
What is REDCap?
ChatGPT plug-in that provides credible links and resources.
What is Scholar-GPT?
ICH
What is International Conference on Harmonization?
Agreement between institutions in which they agree not to share proprietary information; needs to be completed before sharing the protocol.
What is the Confidential Disclosure Agreement (CDA)?
Form that requests for FDA authorization to administer an investigational drug to humans and serves as a cover letter to all submissions to the FDA.
What is investigational New Drug (IND) application aka FDA 1571 form?
Scheduling tool used to determine the availability of the DSMB members.
What is Doodlepoll?
A test that gauges a machine's ability to exhibit intelligent behavior to or indistinguishavle from that of a human.
What is The Turing Test?