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In total, 1174 study notifications were reviewed.
The aim of our study was to investigate the validity of clinical drug study notifications reviewed by the regulatory agency in Finland during the 1990s.
As the inclusion criteria were based upon end of study notifications, original ethics applications were dated between 2003 and 2011.
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For this study, notification data for the period January 1997 to December 2003 were used.
Study notification and requests for voluntary participation were distributed via department manager announcements, hospital-wide emails, posters, and informational plasma screens throughout the hospital.
As part of an internal audit we accessed Integrated Research Application System IRASS) records of research projects that submitted an end of study notification to the South Central, Hampshire A research ethics committee (formally Southampton A) between 1st January 2010 and 31st December 2011.
Where required and before the start of the study, notification and/or approval of the protocol was also obtained from the relevant local competent authorities, ethics committees and/or institutional review boards in each country.
The main weakness of this study was the short time available to researchers for data analysis and publication (a maximum of three years since end of study notification), especially as the literature seems to show that especially clinical drug trials publish on average between 4 and 8 years after a study [ 14].
PrefMiner Algorithm has the ability to determine automatically rules that reflect user's preferences by studying notifications collected in advance in databases.
For our study, public notification was applied according to the requirement of the ethical committee.
" I' ve had very little, if any involvement with the study except notification from you that a particular patient has been included on the study" GP004.
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