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• Human subject research
  ...rm "human subject research" is derived from the use of human beings as the subjects of scientific research. The term "subject" in this context refers to a pers ...rch that involves testing new medical treatments or interventions on human subjects.
  2 KB (233 words) - 02:38, 12 February 2024
• Good Clinical Practice
  == Good Clinical Practice (GCP) == ...provides public assurance that the rights, safety, and well-being of trial subjects are protected and that the results of the trials are credible.
  2 KB (254 words) - 21:59, 11 February 2024
• Clinical investigator
  == Clinical investigator == ...ced: klin-i-kal in-ves-ti-ga-tor) is a medical professional who conducts [[clinical trials]] to evaluate the safety and effectiveness of [[medicinal products]]
  1 KB (183 words) - 05:58, 11 February 2024
• SOP
  ...ls, SOPs are established to store records, collect data, screen and enroll subjects, and submit Institutional Review Board (IRB) applications and renewals.  ...ls, SOPs are established to store records, collect data, screen and enroll subjects, and submit Institutional Review Board (IRB) applications and renewals. Als
  692 bytes (98 words) - 01:01, 14 January 2023
• Human Subject Research
  ...h|behavioral]] studies, and can involve either direct interaction with the subjects or the use of their personal data. * [[Clinical Trial]]: A type of Human Subject Research that tests the safety and effecti
  2 KB (221 words) - 23:09, 14 February 2024
• Sponsor
  ...kes responsibility for the initiation, management, and/or financing of a [[clinical trial]]. ...medical field, it signifies the entity that pledges to oversee and fund a clinical trial or research.
  2 KB (242 words) - 02:02, 5 February 2024
• MBBS
  ...macology, microbiology, and forensic medicine. The clinical phase includes subjects like medicine, surgery, obstetrics and gynecology, and pediatrics.
  2 KB (284 words) - 20:41, 12 February 2024
• Standard procedure
  ...ocedures are established to store records, collect data, screen and enroll subjects, and submit Institutional Review Board (IRB) applications and renewals.  ...ocedures are established to store records, collect data, screen and enroll subjects, and submit Institutional Review Board (IRB) applications and renewals. Als
  880 bytes (111 words) - 02:50, 8 January 2023
• Clinical Trials Directive
  == Clinical Trials Directive == ...as implemented by the [[European Union]] (EU) to regulate the conduct of [[clinical trials]] across its member states.
  2 KB (261 words) - 02:57, 12 February 2024
• Phase I clinical trials
  == Phase I Clinical Trials == ...tion: /feɪz wʌn klɪnɪkəl traɪəlz/) are the first stage of testing in human subjects, designed to assess the safety, tolerability, pharmacokinetics, and pharmac
  2 KB (267 words) - 06:33, 12 February 2024
• Monitoring in clinical trials
  '''Monitoring in Clinical Trials''' ...n accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
  2 KB (277 words) - 19:44, 12 February 2024
• Randomized clinical trial
  == Randomized Clinical Trial == A '''Randomized Clinical Trial''' (pronounced: ran·duh·myzed kli·ni·kul try·uhl), also known as
  2 KB (329 words) - 04:07, 12 February 2024
• Belmont Report
  ...It was published by the [[National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research]] in 1979. ...ree fundamental ethical principles for conducting research involving human subjects. These principles are:
  2 KB (244 words) - 00:27, 9 February 2024
• Treatment and control groups
  ...atients who receive the treatment or intervention that is the focus of a [[clinical trial]]. The results from the treatment group are typically compared to tho ...of subjects or patients who do not receive the experimental treatment in a clinical trial. Instead, they may receive a [[placebo]] or the standard treatment. T
  2 KB (258 words) - 19:42, 7 February 2024
• Clinical data management
  == Clinical Data Management == ...he generation of high-quality, reliable, and statistically sound data from clinical trials.
  3 KB (370 words) - 22:14, 13 February 2024
• Human experimentation
  ...testing new [[medical treatments]], [[drugs]], and [[procedures]] on human subjects. * [[Clinical trial]]: A type of research that studies new tests and treatments and evalu
  2 KB (319 words) - 05:49, 11 February 2024
• Code-break procedure
  ...e''' (pronunciation: /ˈkəʊd breɪk prəˈsiːdʒər/) is a critical process in [[clinical trials]] that involves revealing the treatment assignments in a [[double-bl ...e 'code' or the concealed information about the treatment assignments in a clinical trial.
  2 KB (268 words) - 06:12, 11 February 2024
• Vaccine trial
  A '''vaccine trial''' (pronunciation: /ˈvæksiːn traɪəl/) is a type of [[clinical trial]] that specifically tests the safety and efficacy of a [[vaccine]] be ...h involves several stages including exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing, and quality con
  2 KB (288 words) - 23:04, 8 February 2024
• Sufficient similarity
  * [[Clinical Trial]]: A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy * [[Control Group]]: In a clinical trial, the group of subjects that do not receive the experimental treatment. The results from the contro
  2 KB (263 words) - 06:53, 11 February 2024
• Phase II clinical trial
  == Phase II Clinical Trial == ...ɪnɪkəl traɪəl/) is a second-stage study in the process of [[Clinical Trial|clinical trials]] conducted to assess the effectiveness and side effects of a new [[
  2 KB (227 words) - 06:24, 12 February 2024

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