What is a CRA? Flyer.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
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
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
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.