Clinical Trials Data Management and Quality Assurance from Coursera

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Syllabus

Data Collection Instruments

This module covers the design and organization of data collection instruments to be used in a clinical trial. A well-designed data collection instrument is critically important to the success of a trial because it determines the way that the data are defined, collected, and organized. A study without a well-designed data collection instrument is likely to encounter otherwise avoidable problems.

Data Management

In this module, you’ll learn about data management in the context of clinical trials. You’ll learn definitions and core concepts and explore a few different frequently used data management systems. We’ll look closely at Excel and other spreadsheet programs because they are widely used and help illustrate broader data management principles. You'll also learn about data integrity, which incorporates features of data security, redundancy, and preservation.

Data Assembly and Distribution

Data assembly involves preparing data for distribution to others. In this module, you’ll learn the necessary steps for creating datasets for sharing. We’ll cover data freezes and data locking as well as cleaning, de-identification, sharing, and standards that you and your team can use to make your data more useful.

Performance Monitoring

In this module, you’ll learn how to conduct performance monitoring in clinical trials. Specifically, we’ll discuss a framework for monitoring clinical center performance and protocol adherence through all phases of the trial from start-up through follow-up. The module will conclude with a brief overview of site visits, an important part of a performance monitoring toolkit.

Intervention Management

In this module, you’ll learn about the principles of managing treatment interventions. There’s a considerable amount of heterogeneity in clinical trials, so a number of factors can influence how you deal with the intervention. Factors include the hypothesis, the design, whether it is an improved intervention, and whether it is licensed or experimental. You’ll also learn about different types of drug formulations and how they factor into masking protocols.

Quality Assurance

In this module, you’ll learn about quality assurance, which refers to the various measures that you and your team can take to help prevent mistakes or problems in your clinical trial. These measures can differ throughout the stages of the trial, so we’ll discuss the specific context in which these measures should be used.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Teaches performance monitoring, which clinical research professionals use to track and improve the progress of studies

Taught by Janet Holbrook, PhD, MPH; David M. Shade, JD; and Ann-Margret Ervin, PhD, MPH, who have extensive experience in clinical data management

Covers data integrity, which is essential for ensuring the accuracy and reliability of clinical trial data

Explores different types of data management systems, helping learners make informed decisions about the best system for their needs

Requires some background knowledge in clinical research, which may be a barrier for some learners

Does not cover data analysis, which is a key aspect of clinical trial data management

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Clinical Trials Data Management and Quality Assurance with these activities:

Review clinical trial ethics

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Reviewing clinical trial ethics will help you understand the ethical considerations and guidelines that are essential in conducting clinical trials.

Browse courses on Informed Consent

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Read the Belmont Report and the Declaration of Helsinki
Discuss the principles of informed consent with a colleague
Consider the ethical implications of different clinical trial designs

Review Statistical Methods for Clinical Trials

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This book provides a comprehensive overview of the statistical methods used in clinical trials, and will help you understand the statistical principles underlying the design, conduct, and analysis of clinical trials.

View Fundamentals of Clinical Trials on Amazon

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Read Chapters 1-3 to understand the basic concepts of clinical trial statistics
Work through the examples in Chapters 4-6 to practice applying statistical methods to clinical trial data
Discuss the statistical methods used in your own clinical trial with a statistician

Practice calculating sample size

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Practicing calculating sample size will help you understand how to determine the appropriate number of participants for your clinical trial.

Browse courses on Sample Size Calculation

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Use a sample size calculator to calculate the sample size for a variety of different scenarios
Discuss your sample size calculations with a statistician

Five other activities

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Follow a tutorial on data management in clinical trials

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Following a tutorial on data management will help you understand the principles of data management in clinical trials, and how to ensure the integrity of your data.

Browse courses on Data Management

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Search for a tutorial on data management in clinical trials
Follow the steps in the tutorial to learn about the different aspects of data management
Apply the principles of data management to your own clinical trial

Join a peer group for clinical trial investigators

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Joining a peer group will provide you with the opportunity to connect with other clinical trial investigators and share experiences and advice.

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Search for a peer group for clinical trial investigators
Join the group and introduce yourself
Participate in discussions and ask questions

Attend a workshop on clinical trial quality assurance

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Attending a workshop on clinical trial quality assurance will help you understand the principles of quality assurance in clinical trials, and how to implement quality assurance measures in your own trial.

Browse courses on Data Quality Management

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Search for a workshop on clinical trial quality assurance
Attend the workshop and take notes
Apply the principles of quality assurance to your own clinical trial

Mentor a junior clinical trial investigator

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Mentoring a junior clinical trial investigator will help you to reinforce your knowledge of clinical trial conduct, and to develop your leadership skills.

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Identify a junior clinical trial investigator who you can mentor
Meet with your mentee regularly to provide guidance and support
Help your mentee to develop their clinical trial skills

Contribute to an open-source clinical trial data management platform

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Contributing to an open-source clinical trial data management platform will help you to develop your technical skills and to make a contribution to the clinical trial community.

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Identify an open-source clinical trial data management platform that you can contribute to
Contact the project maintainers and express your interest in contributing
Make a contribution to the project

Career center

Learners who complete Clinical Trials Data Management and Quality Assurance will develop knowledge and skills that may be useful to these careers:

Quality Assurance Specialist

A Quality Assurance Specialist is responsible for ensuring that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines. This course can help you build a foundation in quality assurance by teaching you about the principles of quality assurance, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Quality Assurance Specialist

Clinical Data Manager

A Clinical Data Manager is responsible for managing the collection, storage, and analysis of clinical data. This course can help you build a foundation in clinical data management by teaching you how to design and organize data collection instruments, manage data, and perform performance monitoring. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Clinical Data Manager

Clinical Research Associate

A Clinical Research Associate (CRA) is responsible for managing the day-to-day operations of a clinical trial. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Clinical Research Associate

Biostatistician

A Biostatistician is responsible for designing and analyzing clinical trials. This course can help you build a foundation in biostatistics by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Biostatistician

Data Analyst

A Data Analyst is responsible for collecting, cleaning, and analyzing data. This course can help you build a foundation in data analysis by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Data Analyst

Medical Writer

A Medical Writer is responsible for writing clinical trial protocols, reports, and other documents. This course can help you build a foundation in medical writing by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Medical Writer

Regulatory Affairs Specialist

A Regulatory Affairs Specialist is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements. This course can help you build a foundation in regulatory affairs by teaching you about the principles of quality assurance, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Regulatory Affairs Specialist

Project Manager

A Project Manager is responsible for planning, organizing, and executing clinical trials. This course can help you build a foundation in project management by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Project Manager

Clinical Trial Coordinator

A Clinical Trial Coordinator is responsible for coordinating the day-to-day operations of a clinical trial. This course can help you build a foundation in clinical trial coordination by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Clinical Trial Coordinator

Investigator

An Investigator is responsible for conducting clinical trials. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

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Site Manager

A Site Manager is responsible for managing a clinical trial site. This course can help you build a foundation in site management by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

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Clinical Research Scientist

A Clinical Research Scientist is responsible for conducting clinical trials. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.

See salaries and explore the career path for Clinical Research Scientist

Data Entry Clerk

A Data Entry Clerk is responsible for entering data into a clinical trial database. This course can help you build a foundation in data entry by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.

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Laboratory Technician

A Laboratory Technician is responsible for performing laboratory tests in a clinical trial. This course may help you build a foundation in laboratory testing by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills may be helpful for success in this role.

See salaries and explore the career path for Laboratory Technician

Pharmacist

A Pharmacist is responsible for dispensing medications in a clinical trial. This course may help you build a foundation in pharmacy by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills may be helpful for success in this role.

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Clinical Trials Data Management and Quality Assurance

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