The section of the CSR that represents a factual summary of a full CSR. A CSR synopsis provides information in a condensed format.
A group of individuals with training, qualifications and experience who review access to Clinical Research Data and Information requests that have been denied by AbbVie. The ATCRIB will include as members scientists and/or health care professionals who are not employed by AbbVie.
A written study report that provides details on the design, methods and study results. AbbVie submits CSRs to health regulatory authorities.
Data or information that AbbVie generates for and through the conduct of a clinical trial, including subject-level data, study-level data and protocols.
An evaluation of an investigational or marketed medicine in human subjects.
A general description of the disease or condition the drug will diagnose, treat, prevent, cure or mitigate, including the patient population that is supposed to use the drug.
A clinical study in which participating subjects receive a study-specific intervention (referred to as treatment or a control), as defined by the study protocol, for the purpose of evaluating the intervention and/or collecting data. Interventions may be investigational drugs or marketed products.
An active pharmaceutical or placebo being tested in a clinical trial, including a marketed medicine when formulated or packaged in a different way.
A written document intended for submission to a scientific/medical journal for publication that describes a clinical trial and the results of the trial.
An observational study draws inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus control group is outside the control of the investigator. This is in contrast to an interventional trial/study, where each subject is randomly assigned to a treated group or a control group.
Clinical trials involving new drugs are commonly classified into four phases (I through IV). Each phase has a different purpose and helps scientists answer a different question. If the drug successfully passes through Phases I-III, it will usually be approved by the health regulatory authority. Phase IV studies occur after the drug is marketed and are intended to optimize use of the drug.
A document that describes the objectives, design and methods of a clinical trial. A protocol summarizes how to conduct the study.
The process of submitting clinical trial protocol information and tabular results for posting on public websites such as ClinicalTrials.gov and EudraCT, pursuant to laws and guidance that govern such postings.
The individual who is responsible for utilizing data and information to investigate a scientific hypothesis.
Results that are organized to interpret the outcome of a clinical study. Study-level results present clinical trial data in an objective manner, without subjective analysis or interpretation, usually in tabular or graphic form.
The individual who participates in a clinical trial, either as a recipient of the investigational product or as a control. Subjects may also be patients.
Information on individual study subjects collected during a clinical trial such as demographics, lab results and drug concentrations.