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For all drugs appraised by both NICE and SMC, we calculated the time from marketing authorisation (obtained from the European Medicines Agency website) until publication of guidance.
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The district medical officers were informed and local administrative authorisation obtained for the project before fieldwork started.
Specific authorisation was obtained from each enrolled patient.
Additional authorisation was obtained from the local health committee and the village chief.
Written site authorisation was obtained from the Child and Adolescent Community Health Executive (CACH), Health Department of Western Australia, to display posters advertising the study at all immunisation clinics and child health centres registered with the CACH in the Perth metropolitan area.
A clinical trial authorisation has been obtained from the Medicines and Healthcare products Regulatory Agency MHRAandand the study runs in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, the principles of GCP, the Research Governance Framework for Health and Social Care (Second edition, 2005) and the Data Protection Act 1998.
The appropriate authorisation for the study was obtained from the individual consultants in the Hospitals audited.
All patients included in this study signed a patient authorisation form allowing the information obtained from the Symptom Inventory to be stored in a Symptom Inventory database that is maintained by the James P Wilmot Cancer Center Behavioral Medicine Unit for research purposes.
Authorisation to use the data was obtained from the National Institute for Health and Welfare as required by the national data protection legislation law in Finland (Reference number 1749/5.05.00/2011).
Authorisation to carry out the survey was obtained from the Ministry of Health and Child Welfare of Mali and the district health administrators.
An ethical clearance was obtained from the Cameroon National Ethical Committee and an authorisation to conduct research from the Ministry of Scientific Research of Cameroon for fieldwork.
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