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A standardised operating procedure for the DMEC has been developed specifically for the PREVIEW Study based on MRC guidance, the template produced by the DAMOCLES Study Group and the ICH Harmonised Tripartite Guideline, for Good Clinical Practice.
A CRC or KMD with more than 2 years of clinical experience will record the outcomes in a separate room according to the standardised operating procedure without knowing to which group the patients have been assigned.
Blood samples were collected according to a standardised operating procedure using 0.109 M buffered sodium citrate for the CTC preparation, BD Vacutainer tubes containing K2EDTA for plasma samples and BD Vacutainer tubes containing clot activator and gel separation for serum samples.
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Standardized operating procedures were implemented and controlled.
Some surgeons have objected to complying with standardised operating procedures on the grounds it compromises their freedom, as if the prostrate body before them is simply a canvas waiting for the artist's scalpel.
All procedures during the study will be guided by an extensive set of specifically developed standardised operating procedures (SOPs).
This includes the use of standardised operating procedures, including details of sampling, transport, storage and measurement of the analytes.
Standardised operating procedures for analysing these genetic factors were adopted, and criteria for proper nomenclature were developed.
Standardised operating procedures for image acquisition, nodule evaluation, positive screening results and their management, monitoring of false-positive results and rate of iatrogenic complications, and appropriate follow-up.
All data was anonymised using standardised operating procedures by a data analyst at Beaumont hospital to protect patient confidentiality and privacy.
Physiotherapists will be also be provided with written definitions and quick reference illustrations of standardised operating procedures for each clinical examination used in the study.
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