| # | Module Title | Objectives: Upon completion of this course, you will be able to: |
|---|---|---|
| 1a | Clinical Research and the Drug Development Process, Part 1 | Summarize and differentiate the phases of drug development, testing and approving new prescription medications (i.e., drugs, biologics, devices) including safety and efficacy for human use. Discuss the purpose and timing of review and approval by the US Food and Drug Administration (FDA). |
|
1b |
Understand the importance of a package insert. | |
| 2 | Clinical Research and the Drug Development Process, Part 2 | Describe the roles and responsibilities of key stakeholders in clinical research, including, sponsors, CROs, site personnel (investigators, coordinators) IRB, and participant. |
| 3 | Ethical Considerations and development of GCP | Discuss historical examples leading to clinical research regulations and guidelines and heightened awareness of drug safety. Explain key conceptual documents developed for the protection of human subjects in clinical research: identify ethical considerations for evaluating vulnerable populations for clinical studies; differentiate between negligence, error and research misconduct. |
| 4a | Regulations and Good Clinical Practice, Part 1 | Describe US regulations and international guidelines that are specific to clinical research operations and protection of human subjects. Identify requirements for investigator financial disclosure. Distinguish between an Investigational New Drug application (IND) and New Drug Application (NDA). Recall the 8 sections of ICH GCP. Differentiate between sponsor and investigator responsibilities according to ICH GCP guidelines. |
| 4b | Regulations and Good Clinical Practice, Part 2 | Summarize FDA and OHRP requirements for the informed consent process and IRB responsibilities. Describe the purpose of the IRB. Differentiate between sponsor and investigator responsibilities according to ICH GCP guidelines. Identify three responsibilities of study monitors (Clinical Research Associates). |
| 5a | Study Protocol Development and Content | Discuss the collaborative development of a study protocol, involving multiple professionals for interdisciplinary input. Discuss the requirements for research versus real world practice and the amount of data collected. |
| 5b | Locate and discuss key elements of study protocol (e.g., objectives, study flow, variables for assessing safety and efficacy, study procedures, study visit). | |
| 5c | Basic Study Design Elements | Describe a parallel group study design. Discuss the concepts of randomization, blinding, and control groups. Identify rationale for alternative study design. |
| 6 | Describe the purpose of feasibility analysis to support the selection of sites and participants for a study, including feasibility of the indication. Discuss methods for recruiting, enrolling, and collecting prospective data on participants participating in clinical trials. | |
|
7 |
Documentation and Data Integrity |
Describe the purpose and importance of essential documents. Discuss monitoring in the context of data integrity, including source document verification. Discuss the role of various personnel at the sponsor/CRO and sites regarding essential documents. |
| 8 | Safety Reporting and Implications | Differentiate between the types of adverse events (AE) encountered in clinical trials and examine the role of various professionals in timely AE reporting. Explain AE reporting in the context of drug safety, regulations, implications for product labeling (e.g., boxed warnings), reporting requirements, and study discontinuation. |
| 9 | Monitoring, Quality Assurance, and Audits | Describe the role of the clinical research associate (CRA), clinical study coordinator, and investigator during a monitoring visit. Describe why data quality is important and how taking time early on can save time on the back end as you approach database lock. |
| 10 | Collecting/Managing Data from Clinical Trials | Briefly describe data flow and discuss basic data management concepts, such as data cleaning, queries, electronic data capture, and tools for recording and managing of study data. Identify challenges with remote data monitoring. |
| 11 | Drug Safety and Risk Management | Discuss safety risk management through the clinical development and post-marketing phases including trial discontinuation, risk evaluation and mitigation strategies (REMS), and post-marketing studies. Discuss safety implications for off-label use. |
| 12 | Lifecycle Management | Discuss reasons for lifecycle management of a compound including the business aspects of clinical research, including financial relationships between sponsors, CROs, and investigative sites, other vendors, IRBs, and participants. Identify risks to successful completion of a study and downstream implications. |