CKD: Chronic kidney disease; CRB: Catheter-related bacteraemia; ETOH: Ethanol; HD: Haemodialysis; HEALTHY-CATH: Heparin versus EthAnol Lock THerapY for the prevention of Catheter Associated infecTion in Haemodialysis patients; ICH: International Conference on Harmonisation; NHMRC National Health and Medical Research Councill; PAH: Princess Alexandra Hospital TGA Therapeutic Goods Administrationon.
BHPM: bis- p-hydroxyphenyl -pyridyl-2-methane; CFU: colony-forming unit; CRA: Clinical Research Associates; Ibis- p-hydroxyphenyl -pyridyl-2-methanernational Conference on Harmonisation; ITT: intention-to-treat; IWRS: Interactive Webis- p-hydroxyphenyl -pyridyl-2-methaneycol; PP: per protocol; RCT: randomised controlled trial.
Monitoring of study conduct and data collected will be performed by a combination of central review and site monitoring visits to ensure the study is conducted in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines.
Following harmonisation (ISPOR stage 6) of all target language translations on the basis of back translations, the source and all four target language versions of CDIS were piloted using cognitive debriefing (ISPOR stage 7) in each country.
Thus, preclinical toxicity studies must be designed in accordance with FDA US Food andDrug Administration, International Conferencence on Harmonisation and Committee for Medicinal Products for Human Use guidelines to test the safety of the approach based on a representative process and drug products.
This study will be conducted in accordance with the International Conference for Harmonisation of Good Clinical Practice (ICH GCP) guidelines, and the Research Governance Framework for Health and Social Care.
Clinical studies using human samples are subject to ethical review, research governance and the International Committee on Harmonisation of Good Clinical Practice (ICH GCP) and may also be subject to the Human Tissue Act (2004).
The study was approved by the Institutional Review Board at each center and was carried out in accordance with the International Conference on Harmonisation of Good Clinical Practice guidelines and the Declaration of Helsinki.
The studies were conducted in accordance with the International Conference on Harmonisation of Good Clinical Practice guidelines and the Declaration of Helsinki Principles.
This prospective, phase I/II, open-label dose-escalation study was conducted at six centers in Europe Belgium, Spainn, UK) in accordance with the International Conference on Harmonisation for Good Clinical Practice.
