clinical trial reading + follow-up definicje 13.11 | Quizlet

delivery method, route of administration

the way a drug or treatment is given to a participant, such as by mouth, injection, or infusion

dose/dosage

the specific amount of a drug to be taken at one time or over a certain period, often measured in milligrams or similar units

eligibility criteria

the set of rules that determine who can or cannot take part in a clinical study, usually based on factors like age, health status, or medical history

interventional study

a type of clinical research in which participants receive a specific treatment or procedure, and researchers measure its effects on health outcomes

principal investigator

the main researcher who leads and oversees the clincal study, ensuring it is conducted safely, ethically, and according to the study plan

study staff

the team of professionals who assist in running a clinical study, such as nurses, coordinators and laboratory technicians

protocol

a detailed plan that describes the study's goals, methods, and procedures, including how participants will be treated and what data will be collected

informed consent/consent form/consent to participate

a document that explains all important details about a study - including its purpose, procedures, risks, and benefits - so that participants can decide whether to join

regulatory body/authority

an official organization, often a government agency, that ensure clinical trials follow laws, ethical standards, and safety regulations

U.S. Food and Drug Administration (FDA)

The agency in the U.S. federal government that has the power to approve and disapprove new drugs

corollary

(n.) a proposition that follows from one already proven; a natural consequence or result; (adj.) resultant or consequent; associated, supplementary

to conduct

to lead; to oversee

to yield

to give or supply

side effects

reactions to medicine other than the one intended

comprehensively

of large scope; covering or involving much; inclusive

to evaluate

form an idea of the amount, number, or value of; assess.

to outweigh

to be more important or valuable than something else

efficacy

the ability to produce a desired or intended result

extensively

in a way that covers or affects a large area

to lengthen

to make or become longer

to compensate

to make up for; to repay for services

pivotal

(adj.) vitally important, essential

to vary

to be different

to design

to produce a plan, simulation or model

guideline

an official recommendation or advice that indicates policies, standards, or procedures for how something should be accomplished

to outline

to give a brief account or summary

symptom

subjective evidence of a disease, such as pain or a headache

observational study

a study based on data in which no manipulation of factors has been employed

study coordinator

typically a member of a research team that is responsible for such things as recruiting, screening, and enrolling study participants, and ensuring the adherence to Good Clinical Practice guidelines

research assistant

research employee who provides technical assistance with questionnaire design, data analyses, and similar activities

research nurse

professional member of a research team who provides direct patient care for participants in clinical trials (at any level)

to enroll

to sign up to become a member of some group or activity; to register

completion

the state of being finished

disease progression

the sequence of events that occur during the development of a disease or abnormal condition

to withdraw

to pull out or remove; to move back or away, retreat

to reimburse

(v.) to pay back; to give payment for

to approach

speak to (someone) for the first time about a proposal or request

to distill

purify; refine; concentrate

as appropriate

in a way that is suitable, fitting, or necessary for a particular situation

to enforce

to make people obey a rule or law

to inquire

to ask for information

to assess

to estimate the value of; to measure

to satisfy conditions

to meet or fulfill all the requirements, criteria, or expectations that have been set

clinical trial

consensual experiment directed toward developing a treatment

objective

a thing aimed at or sought; a goal

to bear responsibility

to be responsible for something

compliance

the tendency to agree to do things requested by others

scientific integrity

commitment to intellectual honesty and adherence to ethical principles in scientific research

oversight

responsibility for a job or activity and for making sure it is being done correctly

regulatory requirements

the rules, laws, and guidelines that organizations must follow to operate legally within a specific industry or jurisdiction

quantity

something that has magnitude, size, or amount