These 10 learning modules were designed to provide clinical research teams with fundamental information about clinical trials. They were developed by the Center for Cancer Research's (CCR) Office of Education and Compliance (OEC) to be consistent with U.S. Federal Regulations and Good Clinical Practice. OEC provides clinical research training and compliance activities for the CCR's clinical research staff.
Each module has a list of objectives, required content (e.g., WebEx recordings, PDF of handouts, links to YouTube videos), recommended content (i.e., readings, videos), list of resources, and a link to the evaluation.
Once you have viewed all of the required content for each module, we ask that you complete a short evaluation. After completing the evaluation, you will be redirected to a certificate of completion for your education record. You can add your name and date completed on the certificate and keep with your training records. If at any time the evaluation link doesn't take you to the evaluation but rather the certificate of completion, please copy the evaluation url, paste into your browser, and complete the evaluation.
We hope you find the information helpful.
Adherence to the principles of good clinical practices (GCPs), including appropriate human subjects protection (HSP) is a critical requirement when conducting clinical research. This overview module is divided into 3 required components and 2 recommended readings. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Identify the federal regulations related to human subjects protection (HSP).
- Describe the major historical events that have influenced how research involving human subjects is conducted.
- Describe how the 3 ethical principles of the Belmont Report are applied to clinical trials.
- Define Good Clinical Practice (GCP).
- Describe the 13 principles of GCP.
Required
| Part 1 | Code of Federal Regulations (14 minutes) | Part 1 Handout |
| Part 2 | Nothing basic about it, but we'll try to make it so - Common Rule ABCs with OHRP (35 minutes) | Part 2 Handout |
| Part 3 | Introduction, History and Principles of ICH-GCP (7 minutes) |
Recommended
Readings
Clinical research is research conducted on humans with the goal of generating useful knowledge about human health and illness. A clinical trial is one type of clinical research that seeks to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication or device. This module is divided into 3 required videos and 2 recommended videos. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe five types of clinical trials.
- Discuss basic concepts associated with clinical trial designs.
- Discuss the objectives, endpoints and standard design for Phase I clinical trials.
- Discuss the objectives, endpoints and standard design for Phase II clinical trials.
- Discuss the objectives, endpoints and standard design for Phase III clinical trials.
- Discuss at least 2 goals that can be used for Phase IV clinical trials.
Required
| Part 1 | Types of Clinical Trials (8 minutes) | Part 1 Handout |
| Part 2 | Key Concepts (21 minutes) | Part 2 Handout |
| Part 3 | Phases of Clinical Trials (16 minutes) | Part 3 Handout |
Recommended
What are Clinical Trial Phases? (2 minutes)
Randomization in Clinical Trials (2 minutes)
The clinical trial protocol is the heart of any research project. It is a “recipe” for ensuring that the procedures/measures outlined in the research study are carried out in a consistent, reproducible manner. Once a protocol is written, but before it can be initiated, the protocol must go through a review and approval process. This includes scientific, safety, and ethical reviews.
The module is divided into 3 required videos and 1 recommended video. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe the basic elements of a protocol.
- Identify the types of review that a protocol may go through before it can be initiated.
- Discuss the roles and responsibilities of the institutional review board (IRB).
Required
| Part 1 | Overview of Protocol Development, Review and Approval (15 minutes) | Part 1 Handout |
| Part 2 | Elements of a Protocol (13 minutes) | Part 2 Handout |
| Part 3 | The Who, What, Why and Where of IRB Meetings and Membership (62 minutes – final 12 minutes is Q&A, this is optional) | Part 3 Handout |
Recommended
How Do I Review Thee? Let me Count the Ways: The Types and Manners of IRB Review (47 minutes) Handout
A successful clinical trial program is typically comprised of a team of individuals who are committed to conducting high-quality clinical trials. All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. All research teams are led by a Principal Investigator (PI) and have research participants. Other key staff include, but are not limited to: Nurses, Study Coordinators, and Clinical Data Managers. This module will provide an overview of key roles of the research team. The module is divided into 3 required components (videos) and 3 recommended videos. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe the role and responsibilities of the Investigator as described by OHRP, FDA, and ICH GCP.
Describe the role and responsibilities of the research participant.
- Describe the role and responsibilities of the Research Nurse/Clinical Research Coordinator.
- Describe the role and responsibilities of the Clinical Data Manager.
- Identify clinical research professional organizations.
Required
| Part 1 | Principal Investigator (26 minutes) | Part 1 Handout |
| Part 2 | Clinical Trials Team Members (14 minutes) | Part 2 Handout |
| Part 3 | Clinical Research Professional Organizations (6 minutes) | Part 3 Handout |
Recommended
What is a Principal and Sub-Investigator? (4 minutes)
Introduction to Clinical Research Nursing: Changing and Transforming Patient Care (26 minutes)
The cornerstone of clinical research is the informed consent process. History has taught both investigators and research participants many valuable lessons of the importance of informed consent. For historical milestones related to informed consent and humans subjects protection, refer to the GCP & HSP module. This module is divided into 3 required videos and 1 recommended interactive training. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Discuss the guiding principles of informed consent.
- Discuss the essential elements and regulatory requirements of the informed consent document.
- Discuss strategies to ensure participant-centered informed consent documents and discussions.
- Discuss the difference between consent and assent.
- Discuss the assent process in pediatric clinical trials.
- Discuss the process for obtaining informed consent from non-English speaking research participants.
Required
| Part 1 | Respecting Persons – From Basic Requirements to Embracing Participant-Centered Informed Consent (60 minutes – final 10 minutes is Q&A, this is optional) | Part 1 Handout |
| Part 2 | Pediatric Assent (9 minutes) | Part 2 Handout |
| Part 3 (NIH Staff Only) | An overview of IRB expectations when non-English speaking persons enroll in research: The importance of ensuring comprehension (60 minutes) | Part 3 Handout |
Recommended
Participant-Centered Informed Consent Training (95 minutes)
Clinical research documentation involves a variety of documents from various sources and is authored by several individuals. This overview module is divided into 1 required video. Once you have completed the required part, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe best practices for clinical research documentation.
- Define source documentation.
- Discuss how to handle discrepancies among various source documents.
- Describe the purpose of the regulatory file/binder.
- List the essential elements of the regulatory file/binder.
- Describe when it is appropriate to centralize essential documents.
Required
| Part 1 | Documentation and Document Management in Clinical Research (53 minutes) | Part 1 Handout |
Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring quality data. This module will provide an overview of AEs, including assessment, documentation, recording, and reporting including non-AEs that are reportable to the IRB. The content of this module is from the “Introduction to the Principles and Practice of Clinical Research” course presented by Elizabeth Ness, MS, BSN, RN, CRN-BC™ in July 2023. Once you have completed all 4 required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Define adverse event (AE).
- Define serious adverse event (SAE).
- Define life-threatening event.
- Define unexpected adverse event.
- Define suspected adverse reaction (SAR).
- Define unexpected adverse device effect (UADE).
- Describe what to assess when evaluating an adverse event.
- Describe appropriate documentation of an adverse event.
- Describe common data elements typically captured on case report forms.
- Define when an Investigator is to report an adverse event to the sponsor in an expedited manner.
- Define when a Sponsor is to report an adverse event to the FDA in an expedited manner.
- Define what types of events are reportable to the Institutional Review Board (IRB).
Required
Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity. This module will provide an overview of clinical data management, the development of case report forms, data privacy and security, and quality control. The required content of this module is from the “Introduction to the Principles and Practice of Clinical Research (IPPCR): Data Management Overview,” a four-part video series presented by Christine Gordon, Clinical Data Management Project Manager, CCR, NCI, NIH, in September 2023. There is one recommended video.
Once you have completed the four required videos, please complete the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Discuss what constitutes data management activities in clinical research.
- Describe regulations and guidelines related to data management practices.
- Discuss the data handling processes.
- Describe what a case report form is and how it is developed.
- Discuss quality management activities related to CDM.
Required
Recommended
IPPCR 2016: Data Management & Case Report Form Development in Clinical Trials (60 minutes)
Monitoring and auditing of clinical trials is necessary to assure the rights and safety of patients (i.e., human subjects) are protected, reported trial data are accurate, complete, and verifiable from source documents, and the conduct of trial is in compliance with protocol, good clinical practice (GCP) and applicable regulatory requirements. This module has one video to review which discusses quality management activities in clinical research. Once you have viewed the required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe quality management.
- Describe the purposes, regulations, and guidances related to monitoring of clinical trials.
- Explain the difference between monitoring and auditing.
- Describe the different types of monitoring plans.
- Describe the preparation required for and what is reviewed during a monitoring visit.
Required
| Part 1 | Quality Management in Clinical Research (43 minutes) | Part 1 Handout |
Recommended
FDA Regulatory Requirements for Clinical Investigators and Case Examples (41 minutes)
Understanding the history of the FDA, its role and the Sponsor’s role in the drug development process will provide research team members with a better understanding of how their roles fit into the process. For those investigators who also serve as a sponsor, it is important to understand what that entails and for the research team, what other responsibilities might be required of them. The five required parts of this module are from the “Introduction to the Principles and Practice of Clinical Research” course regarding FDA Product Regulations from February 2023. There are seven recommended videos.
Once you have completed the required parts, please complete the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe the historical perspective of the FDA's regulations governing drug development.
- Explain the drug development and review process in the United States.
- Describe the roles of the Sponsor and investigator in the conduct of clinical trials.
- Identify the mechanisms in place for monitoring the safety of drugs and biologics.
- Explain the importance of study data standards throughout drug development.
Required
| Part 1 | FDA Product Regulations Part 1 of 7 FDA’s Mission and Organization (28 minutes) |
| Part 2 | FDA Product Regulations Part 2 of 7 Investigational New Drugs (INDs) (19 minutes) |
| Part 3 | FDA Product Regulations Part 3 of 7 IND Safety (14 minutes) |
| Part 4 | FDA Product Regulations Part 5 of 7 Licensing Applications for Drugs and Biologics (13 minutes) |
| Part 5 | FDA Product Regulations Part 7 of 7 Study Data Standards (16 minutes) |
Recommended
Videos:
- How a Drug Becomes a Drug (4 minutes)
- How Do Drugs Get Their Name (5 minutes)
- Is There a Difference Between Brand Name Medications and Generics? (9 minutes)
- Early Clinical Trials (18 minutes) - Provides an overview of the drug development process from pre-clinical to early phase clinical trials. NOTE: This was a recommended video in the Trial Design Module as well.
- FDA Product Regulations Part 4 of 7 Expedited Programs (9 minutes)
- FDA Product Regulations Part 6 of 7 Medical Devices and Combination Products (8 minutes)
- FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond (90 minutes)
This activity explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA’s Center for Drug Evaluation and Research, or CDER’s, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States. Continuing Education credits are available through 6/7/2024.