Clinical Research Associate (CRA)

This module explores how scientific principles inform study design and protocol development. It defines what qualifies as a research question and study hypothesis, lists the components of rigorous clinical research, notes some common weaknesses of different protocol designs, details the central elements of a study protocol, explores how to interpret protocols, and delineates the CRA’s role in monitoring a study site’s implementation of a protocol.

Recommended Use: Required
ID (Language): 21178 (English)
Author(s): Jessica Rosenbluth, MS - Syneos Health

This module examines the relevant national and international principles of participant protection in clinical research. It explains the ethical issues involved when working with vulnerable populations and describes the additional safeguards that should be in place to protect such subjects. The module also details the role of the study monitor in ensuring protection of participant rights in an ongoing clinical study.

Recommended Use: Required
ID (Language): 21179 (English)
Author(s): Natasha Williams, BSc - Narra Consulting LLC

This module explores the conception, development, testing, and approval of biomedical products and details the key stages of a biomedical product’s lifecycle. It defines the regulatory pathways for drugs, biologics, and medical devices, while describing how sponsors work with the U.S. Food and Drug Administration to gain approval for product marketing. The module provides CRAs with a working knowledge of the biomedical product lifecycle necessary to facilitate interactions between clinical research sponsors and sites.

Recommended Use: Required
ID (Language): 21180 (English)
Author(s): Robert Michalik, JD, RAC - RegulatoryPro Consulting

This module provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) guideline, with a particular focus on sections that are most relevant to the work of a CRA. The module describes how a CRA’s monitoring activities help a site comply Good Clinical Practice (GCP). The module concludes with introduction to the proposed changes found in the E6(R3) update of the ICH guideline.

Recommended Use: Required
ID (Language): 21181 (English)
Author(s): Chinonso Singleton, MS - LIBRE, LLC

This module covers the roles and responsibilities of study monitors and details a monitoring plan's creation, purpose, and contents. It outlines risk-based and remote monitoring approaches and contrasts these with an earlier traditional model for monitoring. The module also focuses on the essential components of a monitor’s communication with investigators, study staff, and sponsors.

Recommended Use: Required
ID (Language): 21182 (English)
Author(s): Natasha Williams, BSc - Narra Consulting LLC

This module describes the preparation for and conduct of different site visits. It identifies the central actors involved and the common interactions among them. The module also details the key components of a visit follow up.

Recommended Use: Required
ID (Language): 21183 (English)
Author(s): Natasha Williams, BSc - Narra Consulting LLC

This module defines the purpose and use of emerging technologies for study management and data collection. It describes how these technologies enhance risk-based monitoring (RBM). In addition, the module discusses how decentralized clinical trial (DCT) modules are shaping the future of clinical trial conduct.

Recommended Use: Required
ID (Language): 21184 (English)
Author(s): Natasha Williams, BSc - Narra Consulting LLC

This module defines the core aspects of data management, describes quality clinical trial data, defines data-related milestones, and connects data processes to related systems and software. The module also outlines selected data-handling processes and provides CRAs with information on operational activities to maintain data quality at their assigned clinical trial sites.

Recommended Use: Required
ID (Language): 21185 (English)
Author(s): Chinonso Singleton, MS - LIBRE, LLC

This module describes some principles and practices of leadership, communication, professionalism, and teamwork related to clinical research. It describes how a CRA can leverage soft skills to effectively manage stakeholder relationships in a clinical trial.

Recommended Use: Required
ID (Language): 21186 (English)
Author(s): Clareece West, BSc - West-Fenn Enterprise, LLC