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All authors participated in study implementation and provided monitoring of trial conduct.
JD, WL, and GB participated in study implementation, and provided monitoring of trial conduct.
The Trial Manager, or where required, a nominated designee of the Sponsor, shall carry out monitoring of trial data as an ongoing activity.
Each participating country will have a study monitor who will be responsible for overview and monitoring of trial activities at each study site within each country, including maintenance of the trial master file, site pharmacy files and site investigator file.
The logistical problems relate to the rapid identification of the extra resources required to allow continued excellence in day-to-day management and monitoring of trial governance (both in participating centres and in coordinating trials units).
Monitoring of trial data shall include confirmation of informed consent; source data verification; data storage and data transfer procedures; local quality control checks and procedures, back-up and disaster recovery of any local databases and validation of data manipulation.
Similar(52)
Standard safety monitoring of trials (despite all its limitations) and crude reporting of events might be sufficient for clinical decision making in circumstances where the spectrum of harms is reasonably well known and clinically measurable.
[ 7] Visible multiplicities, such as occur with pre-specified subgroup analyses or sequential monitoring of trials are difficult enough, but at least in these circumstances the researchers (and users of the research) know how many multiple comparisons were under consideration.
The sponsor (University College London) was responsible for monitoring of the trial and provided the regulatory authorities REC (trial reference 06/Q0502/70) and MHRA (trial reference 2006-004097-28) with annual safety reports as well as reporting of any suspected unexpected serious adverse reactions.
The DSMC will ensure the safety of study participants through the monitoring of the trial procedure, adverse events, serious adverse events and impact on the trial from any relevant new literature.
Randomisation of patients and monitoring of the trial was performed according to the Standard Operating Procedures from the Coordination Centre for Clinical Trials (KKS) in Heidelberg.
More suggestions(15)
inspection of trial
monitoring of hearing
monitoring of cases
monitoring of testing
monitoring of radiation
monitoring of staff
monitoring of job-search
monitoring of anyone
monitoring of system
monitoring of soil
monitoring of progress
monitoring of activation
monitoring of water
monitoring of groundwater
monitoring of pupil
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