Description

This course focuses on the practical issues of case report form designs, the creation of multi-table database using Microsoft Access, data entry and data management. It provides an in-depth teaching of construction and implementation of databases using Microsoft Access with applications to clinical research, and data management techniques using the Statistical Analysis Software (SAS) relevant to the effective use of data, information and knowledge tools to perform such tasks, but not limited to, as export, manage, merge, retrieve, query, comparison of double entry data for accuracy and consistency, and prepare final database for statistical analysis.

Prerequisite

Completion of Foundation Course in Statistical Analysis Software (SAS) programming.

Learning Outcomes

After the completion of the course, participants will be able to

• Have an understanding of the principles of developing a multi-table database for clinical research studies

• Create annotated case report forms and data dictionary
• Use effectively the Microsoft Access to design a multi-table database that includes creating data entry screens, setting up integrity checks, creating queries, writing macros within the Access environment for automation of data entry tasks, etc.
• Write SAS macros to convert Access tables into individual SAS data sets, merging these SAS data sets to create a single SAS dataset for each study, perform the double-entry comparisons and resolve discrepancies and carry out edit checks to check the accuracy and the consistency of the data across all forms in the study.
• Use Interactive Matrix Language procedures and other advanced features of SAS such as multi-dimensional arrays to conduct a suite of data management tasks to prepare the databases for final statistical analyses.

Topics of Study

• Review fundamental concepts of SAS programming
• Introduction to various study designs, fundamentals of database design, and data management for clinical research studies.
• Discussion of sample clinical case report forms (questionnaires). Creation of annotated case report forms and a study data dictionary. Creation of LABELs and FORMATs files.
• Introduction to Microsoft Access. Creation of tables with validation rules, default values, primary keys, and specifying relations among the tables.
• Creation of data entry screens (Access forms) based on the tables, writing macros within Access to implement integrity checks, data entry rules and skip patterns to ensure the accuracy of data entry.
• Hands on demonstration of data entry, creating Access queries, generating sample queries and reports, and creating two databases (this will be used to illustrate double-entry comparisons later on using SAS)
• Transfer of Access Tables and Reports to Excel. Transfer of these Excel files into SAS datasets as well as Word documents and PDF files using SAS program.
• SAS macros to convert Access tables into individual SAS data sets, merging these SAS data sets to create one SAS dataset for each of the two entries. SAS macros to perform the double-entry comparisons and resolve discrepancies.
• SAS macros to perform various data management tasks such as edit checks to check the accuracy and the consistency of the data across all forms in the study, preparing data sets for various individuals within an organization (statisticians, investigators, monitors, etc).
• Use of advances features of SAS such as multi-dimensional arrays, DO loops, Interactive Matrix Language (IML procedures), SQL procedures, etc, for data manipulation. Introduction to SAS Output Delivery System (ODS) to generate reports, tables and graphs.
• Discussion of topics on data management plans, standard operating procedures (SOPs) for data quality assurance, data backup and correction of errors, ethics of dealing data, HIPAA and confidentiality.