Fast Track to Understanding Clinical Research Modules

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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 participants
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 designs  
6 Feasibility and Study Start Up 
  • 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.