Glossary

Cohort, Treatment or Procedure

Types of medical treatments or procedures patient has undergone

Consent

Explicit patient agreement which can pertain to any of the following: participation in a study, drug administration, performing a surgery, treatment, collection of a sample, and so on.

Diagnosis

Identification of presence of a disease or condition by a licensed medical practitioner.

Diagnostic Tests

Tests that have been administered to the patient or patient's specimen samples to measure patient characteristics.

Medication

Medical drugs that patient has taken.

Patient

A person who participates in a cohort study and is the focus of the research.

Patient History

Includes all patient events and characteristics that may influence medical decision making or study outcome, for example, smoking, drug abuse, alcohol, obesity, miscarriage, and so on

Protocol

A Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. It is a plan that states what will be done in the study and why. It outlines how many people will take part in the study, what types of Subjects may take part, what tests they will receive how often, and the treatment plan. The Sponsor of the Clinical Trial typically designs the Protocol.

Protocol amendment

A written description of a change(s) to or formal clarification of a protocol.

Region

A geographic region in which the translational research will be carried out.

Regulatory Authority

An authority such as FDA and EMEA regulating clinical development processes.

Risk factor

See Patient History

Workbook

Top level node containing several folders in Oracle Health Sciences Clinical Development Center.