Clinical Data Management & SAS Programming
Clinical Data Management (CDM) is an important phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research.
About This Course
Clinical Data Management (CDM) specialist is responsible for clinical study databases and associated data. The Clinical Research Data Management training program provides insights into Clinical Research Data Management activities along with exposure to real-time documentation and scenarios pertaining to roles and responsibilities performed by Clinical Data Management specialist. SAS is the most popular software for clinical data management.
What does Clinical SAS Programmers do?
- Build SAS datasets from Clinical database.
- Develop SAS macros, templates, and utilities for data cleaning and reporting.
- Utilize SDTM guidelines to build datasets.
- Communicate with an internal team to engender deliverables for pharmaceutical and biotechnology clients.
- Implement analyses designated in the protocol.
- Ascertain CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Inscribe SAS programs to engender tables, listings, and figures and analysis datasets.
- Review CRF annotations and data designations.
- Work in tandem with Biostatistics and Data Management member on sundry clinical projects.
- Identify and edit checks per the data validation plan or data management plan.
- Study management reports utilizing SAS.
- Validate the programmed analysis datasets, tables, listing and figures.
- Perform analyses defined in the statistical analysis.
- Prepare clinical and statistical summary reports.
- Communicate with programming and statistics leads.
- Utilize SAS programming skills within the protocol team and perform all programming required for clinical tribulation analysis and reporting.
- Perform quality control on final reports.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Establish monitoring of data transfers for perpetual tribulations to identify study conduct or data quality issues.
Role of SAS in Pharma Industry
- The major role of SAS in Pharma Analytics mainly focusses on generating the TLF’s or TLG’s.
- The CDISC standards like SDTM and ADAM which are used to standardize and to analyze the clinical trial data and the generation of reports can be only done by using Clinical SAS since the FDA accepts only SAS reports.
- The department of BIO- Statistics is using clinical SAS for writing the SDTM and ADAM specifications and in the creation of SAP (Statistical Analysis Plan).
- CDM team is using SAS to perform data analysis before loading the data into certain databases.
- Analysis with clean data and validating the clinical trial data will reduce the pain on the FDA to have a good overview of the clinical reports. Hence most CRO’s are preferring clinical SAS as the best tool to use for its safety and efficiency when compared with other software tools.
What if I belong to Non-Programming background?
The training is from very basic level and people from non-programming backgrounds can easily learn SAS and get jobs in SAS.
Job Roles
- Clinical SAS Consultant
- SAS Analyst
- SAS Associate
- Jr SAS Programmer
- SAS Data Scientist
- Clinical Programmer
- Statistical Programmer
- Statistician Job
- Clinical Trial Programmer
- SAS Developer
- Clinical Data Analyst
- Statistical Programmer Consultant
- Sr. Statistical Programmer
- Principal SAS Programmer
Learning Objectives
Clinical data concepts
Logistic regression using clinical data
Different statistical tools using clinical data
Accessing Clinical Data
Exploring data & Filtering rows
Summarizing Clinical Data
Creating summary statistics reports
Interpreting Statistical measures using univariate procedure
Performing one-way and two-way ANOVA on clinical data
Understanding the concepts of Linear Regression with clinical data
Target Audience
- Bachelor’s / Master’s degree in B. Pharmacy, M. Pharmacy, Pharm D, Bio- Technology, MBBS, MD, BDS, BHMS, BUMS, BAMS, BPT/ M.Sc. (Microbiology/ Biochemistry/ Biotechnology/ Bioinformatics/ Chemistry/ Genetics/ Botany/ Zoology/ Life Sciences/ Biomedical Genetics / Molecular Bio Sciences / Statistics)
Curriculum
28 Lessons30h
Clinical Data Management
Introduction to Data Management
What is Clinical Data?
CRF Design Considerations
Data Entry, Remote Data Entry
Identifying and Managing Discrepancies
Clinical Database & Types
Data Management Plan
Electronic Data Capture
Tracking CRF Data
Managing Lab Data
Collecting Adverse Event Data
Creating Reports and Transferring Data
Enterprise Clinical Data Management Tools
Clinical Data Analysis and Reporting Using SAS Software
SAS Programming
Projects
