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An electronic forum, NGC-L for exchanging information on clinical practice guidelines, their development, implementation and use; An Annotated Bibliography database where users can search for citations for publications and resources about guidelines, including guideline development and methodology, structure, evaluation, and implementation.
A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine
FDA: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA Regulated Clinical Trials. This guidance describes the FDA policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data.
Based upon the work of the international AGREE Collaboration for the quality of clinical practice guidelines, [3] an organised network for organisations and experts working in the field of evidence-based guidelines was proposed in early 2002 at the first international guideline conference in Berlin, Germany. [4]
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
A Clinical Decision Support System (CDSS) is a computerized tool designed to assist healthcare providers in making clinical decisions by integrating medical knowledge with patient data. These systems utilize algorithms, databases, and patient information to provide tailored recommendations, alerts, and reminders to healthcare professionals at ...
The National Collaborating Centre appoints a Guideline Development Group whose job it is to work on the development of the clinical guideline. This group consists of medical professionals, representatives of patient and carer groups and technical experts.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).