data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring of a clinical trial is conducted... 7 KB (808 words) - 01:54, 9 December 2023 |
 | Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical... 112 KB (12,658 words) - 10:41, 24 April 2024 |
time Monitoring in clinical trials, oversight and administrative efforts that monitor a participant's health during a clinical trial Monitoring (disambiguation)... 357 bytes (72 words) - 13:45, 2 June 2014 |
Heart rate monitoring Intraoperative neurophysiological monitoring Monitoring in clinical trials, oversight and administrative efforts that monitor a participant's... 3 KB (379 words) - 00:08, 10 March 2023 |
 | A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient... 5 KB (679 words) - 22:58, 29 February 2024 |
many drugs undergoing Phase III clinical trials in the market. The design of individual trials may be altered during a trial – usually during Phase II or... 32 KB (3,806 words) - 19:25, 5 January 2024 |
self-monitoring Clinical monitor or clinical research associate, a health-care professional who works in monitoring of clinical trials Monitor (warship)... 4 KB (575 words) - 14:22, 1 January 2023 |
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving... 6 KB (677 words) - 01:43, 9 December 2023 |
practice as a clinical research associate. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials, such as... 10 KB (1,054 words) - 19:34, 13 December 2023 |
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a... 13 KB (1,626 words) - 01:43, 9 December 2023 |
enrolled in clinical trials. In some cases, academic members participate in clinical trials as members of SMOs. Clinical investigator Clinical monitoring Clinical... 3 KB (375 words) - 22:22, 5 January 2022 |
S. N. (2007). "Stopping at nothing? Some dilemmas of data monitoring in clinical trials". Annals of Internal Medicine. 146 (12): 882–887. doi:10... 13 KB (1,279 words) - 04:33, 1 January 2024 |
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood.... 13 KB (1,500 words) - 16:06, 10 January 2023 |
participant cannot be eligible to be in the definitive clinical trial. (NLM) Treatment trials Refers to trials which test new treatments, new combinations... 78 KB (11,553 words) - 14:26, 27 October 2023 |
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health... 19 KB (1,865 words) - 18:50, 13 December 2023 |
 | a clinical trial must publicly document it in the Clinical Trials Registry - India. Various government agencies and laws regulate clinical trials. The... 47 KB (5,533 words) - 01:19, 16 December 2023 |
biotechnology Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic... 13 KB (1,428 words) - 12:06, 30 October 2023 |
Contract research organization (redirect from Clinical research organization) development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real... 11 KB (1,075 words) - 13:01, 20 March 2024 |
Sequential analysis (section Clinical trials) ; Lan, K. K. Gordan; Wittes, Janet Turk (2006). Statistical monitoring of clinical trials : a unified approach. Springer. ISBN 9780387300597. OCLC 553888945... 13 KB (1,480 words) - 21:30, 4 January 2024 |
Case report form (redirect from Query (clinical trials)) protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report... 5 KB (582 words) - 05:55, 5 February 2024 |
concept commonly used in the pharmaceutical industry including by health authorities to support decision making. In clinical trials, PPOS is the probability... 10 KB (1,369 words) - 11:51, 2 August 2021 |
Serious adverse event (category Clinical trials) relationship with this treatment.” Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that... 5 KB (597 words) - 01:43, 9 December 2023 |
 | summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results... 24 KB (2,335 words) - 01:58, 1 December 2023 |
Independent safety officer (category Clinical trials) complexity of the trial. Large, multi-site clinical trials are commonly overseen by a Data Monitoring Committee or Data and Safety Monitoring Board (DSMB)... 7 KB (894 words) - 10:44, 10 March 2024 |
Investigator's brochure (category Clinical trials) compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials. An IB is intended to provide the investigator... 6 KB (606 words) - 18:48, 19 July 2023 |
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain... 19 KB (2,588 words) - 06:11, 25 September 2023 |
 | patient monitoring (RPM) is a technology to enable monitoring of patients outside of conventional clinical settings, such as in the home or in a remote... 40 KB (4,511 words) - 16:05, 5 April 2024 |
Cytel (category Companies based in Massachusetts) markets. Cytel specializes in adaptive trials – a type of randomized clinical trial that allows modifications of ongoing trials while aiming to preserve... 9 KB (945 words) - 17:48, 28 April 2024 |
in Pharmaceutical and Biologics Clinical Trials". PR Newswire. 2020-01-23. Retrieved 2024-03-28. Reviews of Statistical Monitoring of Clinical Trials:... 7 KB (799 words) - 00:56, 4 April 2024 |
before entering the clinical trial are discontinued.[citation needed] Data management Randomized controlled trial Safety monitoring Serious adverse event... 2 KB (197 words) - 14:53, 26 November 2023 |