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These include: * Electronic data capture (EDC) * Clinical trial management systems (CTMS) * Electronic trail master files (eTMF) Types of information available from EDC systems are: * Enrollment rate * Screen failures * Protocol violations/deviations * Response data * Serious adverse events He added that types of information available from CTMS or eTMF are site documents, IRB approvals, protocol amendments, informed consent documents and monitoring trip reports. Available real-time data access technology includes: * Web reports * Ad hoc reporting * Data exports * SAS exports * PDF IPPs * EDC workflow * Safety data * Lab data * IVRS/EDC integration * Drug supply data * CTMS integration In real-time analytics, "capturing clean data is required," Hume said. |
CTMS |
CTMF CTMG CTMGA CTMH CTMHA CTMI CTMIS CTML CTMM CTMMA CTMN CTMNC CTMO ctmo. CTMP CTMPC CTMPG CTMPS CTMQ CTMR CTMRC CTMRD CTMRG CTMRM CTMS CTMSICTMT CTMTC CTMU CTMUN CTMV CTMX ctn ctn ctn ctn CTN-A CTNA CTNBP CTNC CTND CTNDH CTNE CTNERHI CTNFS CTNG CTNi CTNJ CTNM CTNMG CTNN CTNNB | |||||
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