Clinical Data Management

The clinical data management(CDM) is responsible for case report form (CRF/eCRF) design, database design and setup, data entry, data cleaning, data coding, data quality control(QC), and providing the clinical trial(CT) data for analysis.

The Clinical Data Management (CDM) plays an essential role in setting up and conducting a clinical trial. The evidence obtained during a clinical trial emphasis the foundation for the eventual protection and effectiveness review, which in effect guides decision-making in the pharmaceutical industry on drug growth.

Cleaning of the clinical data involves purgation of the data programmatically and manually.

Coding the data means applying generic codes to free form of text fields using dictionaries (WHO DD, MEDRA and COSTART) for adverse events(AEs), medications, and medical histories.

Quality control(QC) of the clinical data involves auditing the data to make sure that it was entered properly.

Finally, the data management team provides the data to the statistical programmers through some kind of relational database management system(RDBMS), which can then be imported into SAS.

CDM save time when data management gives a well cleaned and coded clinical database.

The clinical data management(CDM) plan provides data entry instructions, coding instructions, data review instructions, and a data QC plan.

Objectives:

EDC Tool Navigation CRF/eCRF Designing (on EDC Tool) CRF Tracking Development of Specifications for CRFs Data Entry Data Validation Coding (MEDRA, COSTART, and WHO) Test Data Preparation User Acceptance Testing (UAT) Batch Validation Procedures Lab and SAE Reconciliation Export Data Extraction Vendor Management Database Lock

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Introduction to POWER BI

Power BI is a Business Intelligence and Data Visualization tool which used to create an interactive dashboards and BI reports.

It retrieve data from multiple data sources and shape the data based on requirements, perform data analysis and report the results through different types of visualizations.

Power Bi Desktop is a downloadable app for free of cost and is used to create reports. Power BI Desktop is divided into three categories both conceptually and physically which enables how to interact with data and create reports.

Report view

Data view

Relationships view

Power BI components:

Power BI Desktop

Power BI Service

Power Apps

Power BI Gateway

Power BI Mobile Apps

Power BI API

Power BI Report Server

Concepts for Learning

Basics

What is Power BI and why?
Overview of BI concepts and Reporting Tools
How to install Power BI Desktop
Exploring workflow of the Power BI
Settings of the Power BI Desktop
Work spaces
Extracting/ Importing of data from various sources
Import vs Direct Query vs Live Connection
Power Query
Query Editor/Data Transformation
Relationships
M Language
Measures and Calculated Columns

Data Modelling

Creating table relationships
How to Manage Data Relationship
Cardinality and Cross filtering
Data Analysis Expressions (DAX)
Functions: Time Intelligence, Date and Time, Logical, Mathematical, Statistical, Aggregate and Text; Measures in DAX

Data Visualizations

Creating Visualisations
Conditional Formatting
Charts
Tooltips
Slicers
Filtering: Visual level, Page level and Report level
Drill down or up options
Hierarchies
KPI's
Maps
Grouping & Binning
Bookmarks
Buttons
Custom Visuals

Advanced Concepts

Parameters
Drill down or up options
Bookmarks
Security
Dynamic measures, filters, connections
AI enabled Q&A

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Simple introduction to SQL

Introduction

SQL (Structured Query Language) is a common tool for retrieving data from relational databases such as MySQL, SQL Server, MariaDB, and PostgreSQL. Together with R and Python, SQL is one of the top skill in mastering Data Science.

What is SQL?

SQL stands for Structured Query Language, it’s a language for manipulating and talking about data in databases but was originally called SEQUEL for Structured English Query Language.

SQL is the standard language for Relational Database System and all the Relational Database Management Systems (RDMS) like MS Access, Microsoft Transact-SQL or T-SQLMySQL, SQLite, Oracle, Postgres, SQL Server, Sybase and Informix.

What is Syntax?

SQL is followed by a unique set of rules and guidelines called Syntax.

We need to understand what are the basic parts of a statement to start building SQL statements. To get an answer from a database or to make any change to database is called a statement.

All the statements start with any of the keywords like SELECT, INSERT, UPDATE, DELETE, ALTER, DROP, CREATE, USE, SHOW and all the statements end with a semicolon (;).

Statement.

What is a Statement?

A statement is made up of Clauses and Clauses are the basic components of statements that make up the whole and these clauses are constructed out of keywords, which tell to the the database to take some action.

Note: SQL is case insensitive which means SELECT and select have same meaning in SQL statements.

Most Important Commands for daily use

CREATE DATABASE  => To create a new database
CREATE TABLE  => To create a new table
INSERT INTO  => To insert new data into a database
SELECT => To extract data from a database
UPDATE => To update data in a database
DELETE  => To delete data from a database
ALTER DATABASE  => To modify a database
ALTER TABLE  => To modify a table
DROP TABLE  => To delete a table

You can download this Class table and try yourself.

class.xlsx

Download XLSX • 10KB

If want to select all columns from a table we can use an asterisk (*) following a SELECT to select all columns.

SELECT * FROM Class;

If require only Name and Age columns then we can use those particular columns in SELECT clause.

SELECT Name, Age FROM Class;

Happy Learning !!! :)