Clinical Trials Management and Advanced Operations from Coursera

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Syllabus

Protocol Events

Protocol events are problems of varying magnitude that happen over the course of a clinical trial. They can affect patient safety, data integrity, or other aspects of the trial and need to be appropriately categorized and reported. You and your team need to be prepared to recognize, document, and respond to every type of protocol event.

Regulatory Affairs and Trial Misconduct

In this module, you’ll learn about regulatory affairs in clinical trials and how to avoid trial misconduct, which is handled differently from protocol events. Trial investigators are held to federal and local standards in their study conduct, and Institutional Review Boards (IRBs) along with federal agencies are in charge of enforcement. The ramifications for trial investigators engaging in fraud or trial misconduct can result in loss of funding or even legal consequences, so you and your team need to be aware of these expectations and plan for strict compliance throughout your trial.

Standardization, Transparency, and Research Reproducibility

In this module, we'll be discussing standardization of research practices, transparency of study activities, and research reproducibility. Standardization improves dissemination of results, easing the possibility of selective reporting between trials and facilitating a complete view of the full body of evidence. Standards for research practice enable study replication, allowing other investigators to duplicate your results for verification purposes. Transparency allows for effective adjudication by journal editors and others who might wish to review your study data. Finally, protocol development and trial registries hold the investigators to the outcomes they pre-specified in their protocol development.

Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis

In this module, you’ll learn about addressing a clinical trial question of interest by synthesizing evidence from various trials. A systematic review focuses on a specific question, and systematic reviewers use explicit, transparent, and replicable scientific methods to identify, select, appraise, and summarize similar but separate studies. Meta-analysis is an optional component of systematic reviews that allows quantitative assessments of outcomes from similar trials.

Study Documents

In this module, you’ll learn about the standardized study documents used in a clinical trial, including the types of documents and why they’re used. You’ll also learn best practices for creating study documents and the principles for maintaining and managing them.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Develops essential clinical trial management skills, including protocol development and adverse event handling, which are core skills for clinical research coordinators, project managers, and clinical trial investigators

Taught by experienced instructors Ann-Margret Ervin, Anne Shanklin Casper, and Sheriza Baksh, who are recognized for their work in clinical trials, research, and public health

Covers advanced elements of clinical trial management, including regulatory affairs, trial misconduct, and data synthesis, which are essential for ensuring the integrity and validity of clinical research

Examines best practices in study document development and management, which are crucial for maintaining the integrity and reproducibility of clinical trials

May require a strong foundation in clinical research concepts and methodologies to fully benefit from the advanced content

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 Management and Advanced Operations with these activities:

Organize and Review Course Materials

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Enhance your understanding of the course content by organizing and reviewing materials.

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Gather and organize lecture notes, readings, and other study materials.
Review materials regularly to reinforce learning.
Identify areas where additional clarification or study is needed.

Review Clinical Trials: Design and Conduct

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Reinforce your understanding of clinical trial design and execution with an established text.

Browse courses on Clinical Trial Design

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Read the introduction and first three chapters.
Create a set of notes summarizing the key concepts.
Identify examples or case studies you encounter in your work that relate to the text.
Prepare questions you have after reading each chapter.

Review basic statistics

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Solidify your understanding of fundamental statistical concepts.

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Review notes from previous statistics courses or textbooks.
Complete practice problems.
Take a practice quiz or exam to assess your understanding.

Nine other activities

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Refine experience reading research articles

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Reading and interpreting research articles is key for synthesizing evidence to inform best clinical practices, which can support understanding of Advance Clinical Trial Management concepts.

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Search for research articles related to clinical trial management
Read and analyze the research articles
Identify the key findings and conclusions of the research articles
Summarize the key findings and conclusions of the research articles

Systematic Reviews in Health Care: A Practical Guide

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Enhance your knowledge of systematic reviews and meta-analysis for evidence-based decision-making.

Browse courses on Systematic Reviews

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Read chapters relevant to your clinical trial research.
Take notes on key concepts and methods.
Identify areas for further exploration or discussion.

Drill on recognizing and responding to protocol events

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Recognizing and responding to protocol events is critical for maintaining participant safety and data integrity. This activity will help you practice these skills.

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Review the different types of protocol events
Practice identifying protocol events in mock scenarios
Develop strategies for responding to protocol events
Practice implementing strategies for responding to protocol events

Practice Regulatory Affairs Simulations

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Develop practical skills in regulatory affairs through simulated scenarios.

Browse courses on Regulatory Affairs

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Review regulatory guidelines and protocols.
Participate in online simulations as an investigator or IRB member.
Analyze case studies and identify potential regulatory issues.

Prepare a Presentation on Standardized Study Documents

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Gain a deeper understanding of standardized study documents by creating a presentation.

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Research and gather information on standardized study documents.
Develop a presentation outline covering the purpose, types, and benefits of these documents.
Create visuals and examples to illustrate the content.
Present the findings to a group of peers or colleagues for feedback.

Participate in Online Discussion Forums

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Engage with peers to enhance your understanding and gain diverse perspectives.

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Join online discussion forums related to the course topics.
Participate in discussions by asking questions, sharing insights, and responding to others.
Seek clarification and perspectives from peers.

Complete Meta-analysis Tutorial Series

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Develop proficiency in meta-analysis techniques through guided tutorials.

Browse courses on Meta-Analysis

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Follow a series of video tutorials on meta-analysis methods.
Apply the methods to a sample dataset provided in the tutorials.
Interpret the results and draw conclusions.

Connect with professionals in the clinical research field

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Networking with professionals in the field can provide valuable insights, guidance, and support for your learning and career development.

Browse courses on Regulatory Affairs

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Identify potential mentors who work in the clinical research field
Reach out to potential mentors and express your interest in connecting
Schedule meetings or calls with your mentors to discuss your career goals and seek advice

Develop a Protocol Event Management Plan

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Enhance your ability to manage protocol events effectively.

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Review best practices and regulations for protocol event management.
Identify potential protocol events and develop strategies to address them.
Create a written plan outlining the protocol event management process.
Review and update the plan regularly based on feedback and experience.

Career center

Learners who complete Clinical Trials Management and Advanced Operations will develop knowledge and skills that may be useful to these careers:

Data Manager

A Data Manager position is responsible for maintaining data quality and compliance with regulations throughout the duration of a trial. These data are critical for the success of the trial, as they form the basis of all clinical trial results. Taking this course can help someone who wants to be a Data Manager excel in their role by providing advanced training in managing trial data, ensuring protocol compliance, and accurately reporting protocol events.

See salaries and explore the career path for Data Manager

Regulatory Affairs Specialist

Regulatory Affairs Specialists ensure that clinical trials are conducted in compliance with all applicable regulations. They work with investigators to prepare and submit regulatory documentation, and they may also be involved in the review of clinical trial protocols and data. A Regulatory Affairs Specialist needs to stay up-to-date on the latest regulatory requirements, and taking this course can help build a foundation in regulatory affairs and help someone who wants to be a Regulatory Affairs Specialist succeed in their role.

See salaries and explore the career path for Regulatory Affairs Specialist

Clinical Research Associate

Clinical Research Associates (CRAs) monitor ongoing clinical trials to ensure that they are conducted in accordance with Good Clinical Practice (GCP) guidelines and regulations. They also work with investigators to ensure that the rights and safety of trial participants are protected. This course may be useful for someone who wants to be a CRA because it provides training in recognizing and responding to problems and adverse events, complying with regulations, and participating in frameworks that promote transparency.

See salaries and explore the career path for Clinical Research Associate

Medical Writer

Medical Writers create documents that communicate clinical trial information to a variety of audiences, including patients, investigators, and regulators. They need to be able to write clearly and concisely, and they must also have a strong understanding of clinical research. This course may be useful for someone who wants to be a Medical Writer because it provides training in writing clinical trial protocols, reports, and other documents.

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Quality Assurance Auditor

Quality Assurance Auditors evaluate the quality of clinical trials to ensure that they are conducted in accordance with GCP guidelines and regulations. They work with investigators to identify and correct any deficiencies in the trial process. Taking this course may be useful for someone who wants to be a Quality Assurance Auditor because it provides training in recognizing and responding to problems and adverse events, complying with regulations, and participating in frameworks that promote transparency.

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Clinical Project Manager

Clinical Project Managers oversee the day-to-day operations of clinical trials. They work with investigators, sponsors, and other stakeholders to ensure that the trial is conducted on time and within budget. This course may be useful for someone who wants to be a Clinical Project Manager because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Regulatory Affairs Manager

Regulatory Affairs Managers oversee the regulatory affairs function for a clinical trial sponsor. They work with investigators to prepare and submit regulatory documentation, and they may also be involved in the review of clinical trial protocols and data. A Regulatory Affairs Manager needs to stay up-to-date on the latest regulatory requirements, and taking this course can help build a foundation in regulatory affairs and help someone who wants to be a Regulatory Affairs Manager succeed in their role.

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Biostatistician

Biostatisticians design and analyze statistical methods for clinical trials. They work with investigators to develop a research protocol, collect data, and analyze results. This course may be useful for someone who wants to be a Biostatistician because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Investigator

Investigators are responsible for the design and conduct of clinical trials. They work with a team of researchers to develop a research protocol, recruit participants, and collect data. This course may be useful for someone who wants to be an Investigator because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Data Analyst

Data Analysts collect, analyze, and interpret data from clinical trials. They work with investigators to develop a research protocol, collect data, and analyze results. This course may be useful for someone who wants to be a Data Analyst because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Quality Assurance Specialist

Quality Assurance Specialists work with investigators to identify and correct any deficiencies in the clinical trial process. This course may be useful for someone who wants to be a Quality Assurance Specialist because it provides training in recognizing and responding to problems and adverse events, complying with regulations, and participating in frameworks that promote transparency.

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Clinical Research Coordinator

Clinical Research Coordinators assist investigators with the day-to-day operations of clinical trials. They work with participants to recruit, enroll, and follow up with them throughout the trial. This course may be useful for someone who wants to be a Clinical Research Coordinator because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Medical Science Liaison

Medical Science Liaisons provide scientific information to healthcare professionals about a company's products or services. They work with healthcare professionals to educate them about the latest clinical research and to help them make informed decisions about patient care. This course may be useful for someone who wants to be a Medical Science Liaison because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Pharmacist

Pharmacists dispense medications to patients and provide information about their use. They also work with physicians to develop and manage medication plans. This course may be useful for someone who wants to be a Pharmacist because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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Nurse

Nurses provide care to patients in a variety of settings, including hospitals, clinics, and long-term care facilities. They work with physicians to develop and manage care plans, and they also provide education and support to patients and their families. This course may be useful for someone who wants to be a Nurse because it provides training in managing clinical trials, complying with regulations, and participating in frameworks that promote transparency.

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