SAS CDM Online Training Course Content
A CDMS (Clinical Data Management System) is the tool utilized in the clinical research for managing clinical trial data. The data of clinical trial gathered with investigator site within case report type are stored within CDMS. For reducing the error’s possibility because of human entry, systems employ different means to authenticate the data.
Adithyaelearning provides SAS CDM Online Training to the candidates having knowledge in the SAS. Throughout this course the participants will become qualified on the Clinical programming models as well as their usage in field of clinical research. The center areas for the course incorporate data integration, data manipulation, data listings production, figures and tables as per Statistical Examination Plan, as well as generation of reports and graphs. Besides this participants can be trained based on fundamental principles as well as concepts in the statistical methodology as well as clinical trials.
Import and Export Clinical Trials Data
Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).
Manage Clinical Trials Data
Access DICTIONARY Tables using the SQL procedure.
Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc)
Manage Clinical Trials Data
Access DICTIONARY Tables using the SQL procedure.
Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).
Apply Statistical Procedures for Clinical Trials
Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE,
MEANS, SUMMARY).
Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association).
Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample ttests).
Create output data sets from statistical procedures.
Validate Clinical Trial Data Reporting
Explain the principles of programming validation in the clinical trial industry.
Utilize the log file to validate clinical trial data reporting.
Use programming techniques to validate clinical trial data reporting (PROC COMPARE,
MSGLEVEL).
Identify and Resolve data, syntax and logic errors.
Macro Programming for Clinical Trials
Create and use user-defined and automatic macro variables.
Automate programs by defining and calling macros.
Use system options to debug macros and display values of macro variables in the SAS log
(MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).
Report Clinical Trials Results
Use PROC REPORT to produce tables and listings for clinical trials reports.
Use ODS and global statements to produce and augment clinical trials reports.
Clinical Trials Process;
Describe the clinical research process (phases, key roles, key organizations).
Interpret a Statistical Analysis Plan.
Derive programming requirements from an SAP and an annotated Case Report Form.
Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on
Harmonization, Good Clinical Practices)
Clinical Trials Data Structures
Describe the structure and purpose of the CDISC ADaM data model.
Describe the contents and purpose of define.xml.
Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication,
etc.).
Identify key CDISC principals and terms.
Describe the structure and purpose of the CDISC SDTM data model.
Clinical Data Management Course Content;
Components of SAS Different data types
Base/SAS
SAS/STAT
SAS/Graph
SAS/ACCESS
SAS procedures
SAS Procedures
SAS Macros
SAS (working with sql)
Open clinical
Data management
Study planning
Study design
Oracle clinical (overview)
Data base design
Protocol planning
CRF Data entry
Clinical Trails and Clinical Data Management :
Pharmacokinetics
Pharmacovigilance
Clinical data management process
CDISC introduction
CTM systems
Data management plan
Phase trails: preclinical1,2,3 and 4
Drug discovery and development
ICH GCP
Computer system validation
21 CFR 11
CRF designing
Sub Chapter
Introduction to SAS in CDM
Informed consent form
ICH history
GPC guidelines
FDA history
FDA guidelines
IND,NDA reviews
Clinical research study document
CRF reviews and sample CRF’s
CRF data submission
CRF receiving
General abbreviated terms
Introduction to clinical trails
Responsibilities of CRA
Activities of CRA in house
CRA monitoring
Clinical trail monitoring
Responsibilities of PI
IRB
At Adithyaelearning we provide finest SAS clinical research online or the SAS CDM Online Training through offering hands-on workshops, environment of dedicated training away from the office distractions, as well as our tutors are positioned at worldwide locations as per your domestic timings.
Contact Information ;
SKYPE ID: adithyaelearning
Contact : +91 8790679998, 9848371343
EMAIL : adithyaelearning@gmail.com , info@adithyaelearning.com
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