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Necrobiosis lipoidica is a rare, chronic skin condition predominantly associated with diabetes mellitus (known as necrobiosis lipoidica diabeticorum or NLD). [1] It can also occur in individuals with rheumatoid arthritis or without any underlying conditions ( idiopathic ). [ 2 ]
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [2] as:
May 2018: Results of Phase 2b trial posted; October 2019: Results of Phase 3 trial presented [21] June 2020: Results of second Phase 3 trial published [22] The US Food and Drug Administration (FDA) approved abrocitinib based on evidence from three controlled clinical trials enrolling a total of 1615 participants supporting efficacy and safety. [11]
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site.
Necrobiosis is the physiological death of a cell, and can be caused by conditions such as basophilia, erythema, or a tumor. It is identified both with [ 1 ] and without necrosis . Necrobiotic disorders are characterized by presence of necrobiotic granuloma on histopathology.
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
Created in 1999, the CIP program is a result of many years of discussions and planning by organizational members and leaders. It is endorsed by federal regulatory officials, professional associations, many national advisory bodies and IRB professionals who are committed to improving the quality of human research protection programs.