The Veritas Healthcare Solutions LLC 469 7th Ave (between 35th & 36th St...

) NY , 10018 (212) 359 9474 / (212) 470 8252 www.theveritashealthcare.com Email:Info@theveritashealthcare.com

Training Course Description Syllabus Clinical Research Associate / Coordinator

The Veritas Healthcare Solutions LLC NEW YORK | NEW JERSEY www.theveritashealthcare.com Info@theveritashealthcare.com

2012

The Veritas Healthcare Solutions LLC 469 7th Ave (between 35th & 36th St...) NY , 10018 (212) 359 9474 / (212) 470 8252 www.theveritashealthcare.com Email:Info@theveritashealthcare.com

Introduction to the Clinical Research, Drug and Medical Device Development Process,. Bioavailability and Bioequivalence Studies

February 5
Module 1

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 investigators brochure Clinical steps in BA/ BE studies, Volunteer recruitment and selection, Administration of the drug and biologic material collection, Reporting of AE and SAE.

February 12
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, and Describe the site selection process, Structure and content of research protocols, Explain site evaluation of a protocol to determine feasibility.

February 19
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.

The Informed Consent, HIPAA and the Investigational Review Board , Pharmacovigilance

February 26
Module 4

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. Clinical Drug Safety and Pharmacovigilance, Good Pharmacovigilance Operations, Pharmacoepidemiology, The Regulatory and Legal Basis of Pharmacovigilance, Benefit-Risk Management of Healthcare Products

Clinical Trial Conduct, Monitoring and Record Keeping

Ma rc h 4
Module 5

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.

The Veritas Healthcare Solutions LLC 469 7th Ave (between 35th & 36th St...) NY , 10018 (212) 359 9474 / (212) 470 8252 www.theveritashealthcare.com Email:Info@theveritashealthcare.com

M ar c h 1 1
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.

March 18
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.

M ar c h 2 5
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.

Data Management in Clinical Research

A p ri l 1
Module 9

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.

Clinical Research Contracts & Budgets, Negotiation & Evaluation

April 8
Module 10

Discuss components of a budget & tools needed for budget completion, Describe the process of building a budget, Evaluate the financial feasibility of conducting a study, Identify the ethical and regulatory considerations that impact a clinical trial budget, Discuss the financial and legal contract issues and the negotiation process, apply principals of negotiation to clinical research budget finalization.