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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.
ICH E6(R2): Good clinical practice [1] is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. [2]
They are suggested in clinical practice guidelines released by various national and international diabetes organizations. [12] [13] The targets are: Hb A1c of less than 6% or 7.0% if they are achievable without significant hypoglycemia [14] [15] Preprandial (before eating) BG: 3.9 to 7.2 mmol/L (70 to 130 mg/dL) [14]
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The American Diabetes Association (ADA), which produces guidelines for diabetes care and clinical practice recommendations, recently updated its "Standards of Medical Care" in January 2019 to acknowledge that routine self-monitoring of blood glucose in people who are not using insulin is of limited additional clinical benefit. [49]
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.
Since its establishment it developed several evidence-based guidelines or wherever possible expert consensus to drive quality of inpatient diabetes care. [3] [4] The guidelines have been widely used across the UK and helped reduce variations by standardising approach to inpatient diabetes care. [1] Hypoglycaemia [5]
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