Research Basics
Research involving people intended to discover or verify information for the purpose of adding to/improving medical knowledge and/or treatment. Determines safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use.
What is a Clinical Research Study?
Original documents, data, and records
What are Source Documents?
Maximize benefits and minimize harm
What is Beneficence?
Federal agency responsible for the regulation and enforcement of Drug evaluation and distribution policies.
What is the Food and Drug Administration (FDA)?
Document that outlines how a research study is to be conducted, ensures the safety of participants and the integrity of data collected
What are Clinical Protocols?
What is efficacy?
A document that sets out information about person, including qualifications, employment history and interests.
What is Curriculum Vitae (CV)?
Process of informing a research participant about what to expect during an experiment, any risks involved, and the implications of the research, and then obtaining the person's consent to participate
What is Informed Consent?
The person who is primarily in charge of research on a project that is sponsored or funded by an organization.
What is a Principal Investigator?
Characteristics that the prospective subjects must have if they are to be included in the study.
What are Inclusion Criteria?
A process of randomly assigning subjects to different treatment groups
What is Randomization?
International ethical and scientific quality standard for designing, conducting, or recording, and reporting trials that involve the participation of human subjects.
What is Good Clinical Practice (GCP)?
A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial
What is a Medical Monitor?
Characteristics that eliminate a potential subject from the study to avoid extraneous effects?
What is Exclusion Criteria?
In an experiment, the group that is not exposed to the treatment; contrasts with the experimental group and serves as a comparison for evaluating the effect of the treatment.
What is a control Group?
The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal Requirements. (21 CFR, sec. 56.102)
What is IRB approval?
Systems and procedures designed to ensure that a study is being performed in accordance with Good Clinical Practice guidelines and that all the data being generated is accurate.
What is Quality Assurance?
committee of administrators, scientists, and community members that reviews proposals for research involving human participants
What is the Intuitional Review Board (IRB)?
An experiment in which neither the participant nor the researcher knows whether the participant has received the treatment or the placebo.
What is a double Blind Study?
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2)
Adverse Event (AE)
What clinical research phase is a drug's safety tested by increasing the dose to establish which doses are safe and well tolerated?
What is Phase I
A clinical trial in which subjects and investigators are aware of the treatment received.
What is an Open Label Study?