Pharma Clinical Research Inc

Healthcare through Research


The following is a list of courses that we offer.

Course # 9201: Clinical Site Management
Course # 9202: Site Management For Investigator
Course # 9203: Good Clinical Practice For Investigators
Course # 9204: HIPAA Privacy Rule Compliance

Course # 9201: Clinical Site Management

The course is designed for a wide audience seeking training and expertise in real-world clinical trial management. It is designed especially for those interested in collaborative research, is a series of lectures and seminars designed to introduce students to concepts and issues in data collection and database management, protocol development, regulatory affairs, and research ethics.

This course satisfies the practical applications requirement as well as the scientific and ethical conduct requirement for the Certificate Program.

Who should attend the course?

Physicians, Physicians Assistants, Pharmacists, Pharmacologists, Medical Technologists, Laboratory Technicians, Physical Therapists, Respiratory Therapists

The Participant will be able to:

  • Describe the drug development process and roles/opportunities in Clinical Research.
  • Institute and obtain proper Informed Consent.
  • Understand the latest Good Clinical Practices.
  • Learn to employ efficient subject recruitment methods.
  • Develop a suitable clinical trial protocol and suitable study budget.
  • Identify adverse effects and proper reporting format.

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Course # 9202: Site Management For Investigator

Drug Development

  • Definitions and Background
  • Pharmacokinetics & Pharmacodynamics
  • Phases and Concepts of IND and NDA
  • Subject Populations (Pediatric, adult, aged and WOCBP)

Clinical Study Management

  • Patient recruitment
  • Patient screening
  • Informed Consent Administration
  • Randomization and Drug Titration
  • Patient Maintenance and data collection

Investigational Drug

  • Drug Storage and Administration
  • Concomitant Medications Side Effects
  • Breaking the Blinding Code
  • Controlled Substances

Data Collection and Documentation

  • Organized data collection and tracking
  • Case Report Forms
  • Study File Supervision
  • Source Documents Maintenance
  • Regulatory Records
  • Queries Supervision

Drug Adverse Events

  • Adverse Events Diagnoses
  • Differences between AE and SAE
  • Documentation and Reporting of SAE

Investigational Device

  • Federal Regulation (21 CFR Parts 50, 312, 812)
  • General definitions and concepts
  • Differences between drug and NDE studies
  • Handling and shipment of devices
  • FDA and IRB Requirements

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Course # 9203: Good Clinical Practice for Investigators

 The course provides the basic knowledge of clinical research and describes methods to conduct clinical trials according to the US and internationally agreed-upon guidelines for Good Clinical Practice.

Good Clinical Practice (GCP)

Description: Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensures the protection of the rights, safety, and well-being of trial subjects and the credibility and integrity of clinical trial data. This course reviews clinical trials, GCP guidelines and informed consent.

 Human Subjects Protection

  • Development of Ethical Concepts
  • Helsinki Declaration
  • Belmont Report
  • Role of FDA
  • Role of Institutional Review Board
  • Informed Consent Elements

ICH Guidelines

  • Organizational Structure
  • Classification and Implementation Steps
  • Safety
  • Efficacy
  • Multi-Disciplinary Factors
  • Common Technical Documents (CTD)
  • Future Implementation Plans

GCP Guidelines

  • Introduction
  • FDA and Code of Federal Regulations (CFR)
  • Comparison between ICH and GCP
  • Safety of human subjects
  • Efficacy of drug
  • Safety of drug: Adverse Events
  • Documentation Strategies

Role and Responsibilities of Clinical Investigator

  • Investigator Participation (FDA-1572)
  • Financial Declaration (FDA-3454)
  • Staff Assignment and training
  • Privacy of Medical Information Training
  • Contracts and Budgetary Issues
  • Study Protocol Training

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Course # 9204: HIPAA Privacy Rule Compliance

The course will explain and outline the requirements of new Federal Law known and HIPAA (Health Insurance Portability and Accountability Act-1996), which focuses on safeguarding the privacy and confidentiality of personal Health Information of patients.

The course will provide specific details of the HIPAA Privacy Rule (45CFR Part 160, 162 and 164) Standards and their applications to all health care providers, health plans, clearing houses and their business associates.

After successful completion of the course , the participant will be able to understand the requirements of HIPAA compliance and sanctions for non-compliance.

Overview of HIPAA

  • Definitions and Background
  • 51 CFR Parts 160-164 and Role of DHHS
  • Covered Entities
  • Components of HIPAA
  • Requirements and Non-Compliance Penalties

Privacy Rule-1: Basic Concepts

  • Overview
  • Concepts of PHI, TPO and MNI
  • Privacy Officer and Management
  • Authorization and Disclosures
  • Implementation of Privacy Rule

Privacy Rule-2: Privacy Notice

  • Policies for TPO disclosures of PHI
  • Policies for Non-TPO issues
  • Patients Rights
  • Policies for complaints
  • Role of Privacy Officer in Implementation

Privacy Rule-3: Policies and Procedures

  • General Administration
  • Staff Responsibilities
  • Education and Training of Staff
  • Documentation and Record Keeping
  • Policies for Disclosures of PHI
  • Relationship with Business Associates
  • Electronic Transactions

Privacy Rule-4: Business Associates

  • Definition and Kinds
  • Use or Disclosure of PHI
  • Availability or Access of PHI
  • Safety and Destruction of PHI
  • New or Revision of Contracts

Privacy Rule-5: Privacy Plan

  • Privacy Overview
  • Privacy Officer and mechanics of privacy management
  • PHI: Access, authorization, disclosure and safety Plan
  • List of contracted Business Associates
  • EDI Plan for testing and implementing HIPAA standards

HIPAA Education and Training Program

  • Definitions and Responsibilities of Staff
  • Old and New Staff Training
  • Training for Privacy and Security Issues
  • HIPAA Standards Training
  • Electronic hardware and software training for EDI

Electronic Health Care Transactions & Code Sets Standards

  • Goal and Objectives
  • ICD-9, CPT-4 and HCPCS Codes
  • New HIPAA Standards Implementation
  • Electronic Data Interchanges (EDI)
  • EDI Testing and Implementation

Security Rule

  • Overview and Current Status for Compliance
  • Comparison with Privacy
  • Electronic and Non-Electronic Data Security
  • Methods of Implementation

National Identifiers

  • Types of Identifiers
  • Goals and Objectives

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