CRA Terms and Definitions Flashcards
What does ALCOA-C stand for?
Attributable, Legible, Contemporaneous, Original, Accurate and Complete
What does Arm mean in Clinical Research?
A group of people in a clinical trial who receive the same intervention. Studies can have 2 or more research arms. (1 arm - standard treatment, 2nd arm - investigational treatment)
What does Assent mean?
Assent is the agreement of someone not able to give legal consent to participate in the activity. (ex. Child) Assent is not always required by law but may be an IRB requirement.
Baseline
The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. (ex. lab tests)
What does CAPA stand for? What is it?
Corrective Action Preventative Action Plan, Improvements to an organization’s processes taken to eliminate causes of non-conformities and other undesirable situations. (ex. major protocol deviations - action plan to fix the problem)
What does Conmed stand for? What is it?
Concomitant Medication - Prescription and over the counter drugs and supplements a study participant has taken along with the study intervention. (ex. vitamins, cholesterol meds)
What is a comparator?
A drug that has already been approved and licensed and is being used on the market to treat patients.
What does double-blind mean?
Only the pharmacist knows what study medication a participant is receiving, the subjects, doctors, nurses, and other clinical trial staff are not informed.
What is the definition of Eligibility Criteria?
The requirements that people who want to participate in clinical study must meet. It includes both inclusion/ exclusion criteria and are defined in the protocol.
What does ICF stand for? Define it.
Informed Consent Form - The document used in the informed consent process. It should include the purpose of research, duration, risks, benefits, visit schedule, compensation, and contact information should an injury occur during the study.
