Clinical

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INTRODUCTION OF CLINICAL DATA MANAGEMENT

Clinical trials are designed to find specific answer to clinical question. Researchers need data to prove or disprove their theory. Hence, the quality of data comes into picture and becomes pivotal for success of whole clinical trial. For a Clinical Trial to be successful, it requires quality data to be collected. The quality of data is ensured by the Clinical Data Management d read more..
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CALCULATING BOR FROM LESION SIZE USING RECIST CRITERIA: A BRIEF GUIDE TO SAS PROGRAMMER

Background:RECIST stands for Response Evaluation Criteria in Solid Tumors and serves guidance for assessing tumor shrinkage and disease progression, an important endpoint in many Oncology Clinical Trials. Currently, the revised version is RECIST v1.1, published in 2008 (Eisenhauer E.A. et al) and is used by Physicians, Statisticians, and Clinical Scientists to asses read more..
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PATIENT PROFILE AND PATIENT SAFETY NARRATIVES

Patient profile is a listing of all (or selected, sometime) data for individual subject in clinical study organized by time. Subject can be patient or healthy volunteer, though it is referred as Patient Profiles. Patient profiles are optional in submission to FDA.However, patient profiles were recommended to submit in pdf file in CRT (Case Report Tabulation) to FDA previously (as pe read more..
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SAS LOG: ERROR, WARNINGS, NOTES -HOW TO MANAGE THEM?

SAS Clinical Solutions Let's continue SAS Clinical Solutions with SAS log's ERROR, Warning and Notes handling. We show in previous blog about ERRORS and now, let's discuss on WARNINGS and NOTES*********************WARNING************************;a. WARNING: Multiple lengths were specified for the variable state by input data set(s). This may ca read more..
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