What is a CRA? Flyer.pdf     Course Description.pdf

 A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor.  The title will vary from company to company.  The job description will be the same.  A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials. 

Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and experience to monitor their studies 21 CFR 312.53 (d).  ICH Guidelines 5.18.2 (b) also states that Monitors be appropriately trained and their qualifications documented. 

The major responsibilities of a CRA are:

• Assure the protection of the rights, safety and well being of human study subjects.

• To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.  

• Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.

• To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately. 

• To make certain that the scientific integrity of the data collected is protected and verified.

• Assure that adverse events are correctly documented and reported.

• Review all case report forms and compare them to source documents.

• This onsite training program teaches you all the responsibilities of the CRA. 

CRA / CRC Clinical Research Training Course Description

Module 1 Introduction to the Clinical Research, Drug and Medical Device Development Process: Summarization of the drug and device development process, Review of regulatory oversight governing drug and medical device studies, Define the scientific method and its place in clinical research, Recognize study designs in clinical research, The role of statistics in clinical research, Review the structure of the Investigator’s Brochure

Module 2 Clinical Research Personnel, Service Providers and Site Selection Process: Describe the roles of clinical research personnel and responsibilities, Compare the role of service providers and services, Describe the site selection process, Structure and content of research protocols, Explain site evaluation of a protocol to determine feasibility

Module 3 Regulatory Oversight and Human Subject Protections: Review the evolution and role of human subject protections, Review the roles and responsibilities of regulatory agencies, Identify regulations that govern clinical research, Review and summarize Good Clinical Practice (GCP) Guidelines

Module 4 The Informed Consent, HIPAA and the Investigational Review Board: Review IRB roles and responsibilities, Review informed consent document requirements, Describe strategies for conducting and documenting the informed consent process, Review informed consent considerations for medical devices, Review and summarize privacy issues and the impact of HIPAA on clinical research.

Module 5 Clinical Trial Conduct, Monitoring and Record Keeping: Describe the importance and logistics of the investigator meeting and site initiation visits, Identify and describe good study conduct, Describe and recognize the different types of site study visits, Review and explain the importance and logistics of monitoring visits, Describe standard operating procedures (SOPs) for clinical research.

Module 6 Subject recruitment & retention, Study Medication Compliance & Accountability and Study Site Close-out Procedures: Identify and review recruitment and retention strategies, Apply key regulatory requirements to study medication accountability and compliance, Describe the logistics and content of the study site close-out visit, Review best practices for study site close-out

Module 7 Safety Monitoring for Adverse Events and unanticipated Problems: Define and classify adverse events, Describe adverse event recording, Distinguish between reporting requirements for adverse events and unanticipated problems, Review the relevance and impact of adverse event reporting.

Module 8 Audits, Inspections and Quality Assurance in Clinical Research: Identify pertinent regulations related quality assurance, audits, and inspections, Review the audit process, Audit & inspection preparation, Describe expectations of an audit or inspection, Explain potential outcomes of an audit or inspection.

Module 9 Data Management in Clinical Research: Review the role of data management in the clinical research process, Describe the process used to define, collect, and review clinical data, Review the differences between paper-based and electronic data capture systems, Recognize poor quality data and learn the corrective actions, Describe the differences between regulated and non-regulated research in data management.

Module 10 An overview of Medical Device Trials for the CRA and CRC: Define medical devices, Review the different classes of medical devices, Review the differences between medical device trials and drug trials for the CRA and CRC, Review the pathway to medical device approval.