Good Clinical Practices
If a mistake is made on a CRF, the error should be crossed out, and these three elements should be written above the error.
What are the initials, date, and correction reason.
The purpose of this visit is to ensure an investigator and a clinical site have the capability to conduct a study.
What is a Pre-Study Visit or Prequalification visit
This document describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
What is the Clinical Protocol
Test status signaling failure to complete or generate a result.
What is an Exception
Administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities
What is an Institutional Review Board (IRB)
Form used for the Principal Investigator to assign study-specific duties to different members of the research study team.
What is the Delegation/DOA log
On May 20th, the world celebrates this "holiday"
What is International Clinical Trials Day
Can be performed on a daily, weekly, monthly, triannual, quarterly, semi-yearly, or as-needed basis.
What is maintenance
Internal system used to review, exclude, and modify study testing data.
What is Experiment Data Managment System (EDMS)
This document contains the submission of information concerning compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies.
What is a financial disclosure form
In 1714, the first clinical was conducted by James Lind to test treatment for this disease.
What is scurvy.
Data-sharing software application between laboratory instrumentation and Abbott internal systems for the transfer of instrument data
What is AbbottLink
Any untoward medical occurrence that: 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
What is a Subject Serious Adverse Event
The minimum number of years the investigator shall retain the site file records following the date a marketing application is approved
What is 2 years.
The document provides all relevant information about the trial's purpose, risks, benefits, alternatives, and procedures to a potential participant.
What is the informed consent
NT-proBNP is short for
what is N-terminal pro brain natriuretic peptide
The default settings are:
1-2s is a warning
1-3s is a failure
What are Westgard rules
Document in which data collected for a clinical trial is first recorded.
What is a source document
These regulations established in 1988 include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
What are the Clinical Laboratory Improvement Amendments (CLIA)
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 in this study categorization.
What is Minimal Risk?
Technology that is used on Alinity i Systems to determine the presence of antigens, antibodies, and analytes
What is Chemiluminescent microparticle immunoassay (CMIA)