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2. Clinical research associate - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_associate

   Clinical research associate. 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 ...

3. Clinical trial management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial_management...

   Clinical trial management system. A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and ...

4. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...

5. Good clinical practice - Wikipedia

   en.wikipedia.org/wiki/Good_clinical_practice

   Good clinical practice. In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...

6. Clinical research coordinator - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_coordinator

   Clinical research coordinator. 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 ...

7. Clinical data management - Wikipedia

   en.wikipedia.org/wiki/Clinical_data_management

   Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...