Register Now

FREE PHARMACY COURSES
Certification Verification

Clinical Research Associate

PM-CCRA

Pharma Research - Certified Clinical Research Associate

Course Fee: 24999/- Duration: 3 Months

To impart an in-depth training and skills on specialized job functions of a Clinical Research Associate (CRA).

If you are International student- Please pay here through PayPal


Online Examination fee
Name
Contact Number



Course Overview

About Clinical Research Associate Certificate

Currently, the Clinical Trails industry tracks 200,000 + clinical trials worldwide and the data show that there has been a substantial increase in global clinical trials performed by sponsors over the past decade.

The challenge of producing reliable and useful data has also increased as a result of globalisation. Since the effectiveness of the clinical trial depends largely on the quality of the clinical trial data generated, it is the primary responsibility of the Clinical Research Associate (CRA) to track the clinical trial. “A Clinical Research Associate (CRA), also known as the Clinical Trial Track, is a healthcare professional primarily responsible for overseeing, planning, reporting and maintaining the overall progress of a GCP-compliant clinical trial.” The online course “Certification Training for Clinical Research Associate (CTCRA)” would provide you with an in-depth knowledge of all positions.


Who Should Take This Course?

  • Clinical Research Professionals
  • Aspirants (students/ working professionals) from the following health science background: Pharmacy, Medicine, Dental, Nursing, Public Health, Life-Science, Physiotherapist, Traditional/ Alternative Medicine etc.

What am I going to get from this course?

  • 15 high-quality learning modules with an online exam.
  • In-depth knowledge in applicable guidelines
  • Learn clinical trial study process
  • Learn detailed roles and responsibilities of clinical research associate (CRA)
  • Hands-on-Training via mock clinical trial documents
  • Certificate and Performance Card on successful completion
  • Opportunity to explore your career in Clinical Research Operations as CRA.

Curriculum

CLINICAL RESEARCH

Module 1 1. Introduction to Clinical Research and Drug Development
Unit 1 1. What is Clinical Research (CR) and its significance(CR)
Unit 2 1.2 Phases of Drug Development (Pre-clinical to Post-marketing)(CR)
Unit 3 1.3 Types of Clinical Trials (Interventional vs. Observational)(CR)
Unit 4 1.4 Key stakeholders in CR Sponsor, CRO, Investigator, IRBIEC, Regulatory Authorities(CR)
Module 2 2. Overview of ICH GCP E6 (R3) & Quality Systems
Unit 1 2.1 History and purpose of ICH GCP
Unit 2 2.2 The Core Principles of ICH E6(R3)
Unit 3 2.3. Quality_by_Design
Unit 4 2.4 QMS_in_Clinical_Trials
Unit 5 2.5 Training requirements and documentation within a QMS
Module 3 3.Good Clinical Practice (GCP) Principles
Unit 1 3.1 Ethical Principles (Belmont Report, Declaration of Helsinki).
Unit 2 3.2 Principles of GCP Data integrity, records retention, proportionate procedures
Unit 3 3.3 Trial Processes and Measures being Proportionate to Risk.-Risk-Proportionate_Trials
Unit 4 3.4 Essential Documents for the Conduct of a Trial
Module 4 4. Clinical Trials Protocol, Design, and Methodology
Unit 1 4.1 Clinical Trials Protocol, Design, and Methodology
Unit 2 4.2 The Clinical Trial Protocol Components and Amendments
Unit 3 4.3 Trial Designs Parallel, Crossover, Factorial
Unit 4 4.4 Adaptive Clinical Trial Designs Concepts, Advantages, Challenges
Unit 5 4.5 Blinding and Randomization
Module 5 5. Institutional Review Board (IRB) & Independent Ethics Committee (IEC)
Unit 1 5.1 Purpose, Composition, and Authority of the IRB & IEC
Unit 2 5.2 Types of Review (Full, Expedited, Exemption)
Unit 3 5.3 Continuing Review and Reporting Requirements
Module 6 6. The Investigator’s Responsibilities to the IRB/IEC
Unit 1 6.1 Investigator’s Role and Responsibilities
Unit 2 6.2 Communication with the IRB_IEC
Unit 3 6.3 Global Regulatory Bodies
Module 7 7.Investigator Responsibilities in Clinical Trials
Unit 1 7.1 Qualifications and Resources of the Investigator Site
Unit 2 7.2 Investigator Oversight and Delegation of Tasks (Delegation Log)
Unit 3 7.3 Informed Consent Process Oversight
Unit 4 7.4 Accountability for Investigational Product (IP)-IP_Accountability
Unit 5 7.5 Compliance with the Protocol and Regulatory Requirements-Compliance_in_Clinical_Trials
Module 8 8.Roles and Responsibilities of Sponsor & Clinical Trial Monitor
Unit 1 8.1 The Sponsor’s Overall Responsibilities
Unit 2 8.2 Risk-Based Quality Management (RBQM)
Unit 3 8.3 The Role of the Clinical Research Associate (CRA)
Unit 4 8.4 Monitoring Types Centralized, On-site, and Remote Monitoring
Unit 5 8.5 Monitoring Plan Components and Requirements
Module 9 9.Informed Consent Process & Patient-Centricity
Unit 1 9.1 Key Elements of a Valid Informed Consent Form (ICF)-english
Unit 2 9.2 The Informed Consent Discussion (The Process, Not Just the Document)
Unit 3 9.3 Special Considerations for Vulnerable Populations
Unit 4 9.4 Electronic Consent (eConsent) and Regulatory Acceptance
Unit 5 9.5 Participant Rights and Withdrawal from the Study
Module 10  Safety Reporting: Adverse Events & Pharmacovigilance
Unit 1 10.1 Definitions (AE), (SAE), (ADR)
Unit 2 10.2 Seriousness Criteria and Expectedness
Unit 3 10.3 Immediate Reporting Requirements and Timelines
Unit 4 10.4 Overview of Pharmacovigilance (PV)
Unit 5 10.5 Safety Data Reconciliation
Module 11 Site Initiation Visit (SIV) and Essential Documentation
Unit 1 11.1 Purpose and Execution of the Site Initiation Visit (SIV)
Unit 2 11.2 Reviewing the Investigator Site File (ISF) Setup
Unit 3 11.3 Trial Master File (TMF) and Electronic TMF (eTMF) systems
Unit 4 11.4 Regulatory Inspection Readiness in Clinical Trials

PHARMACOVIGILANCE

Module 1 1. Introduction to pharmacovigilance
Unit 1 Introduction to Pharmacoviginalce
Unit 2 The history of PV
Unit 3 The Burden Of Adrs And The Need For Pv
Unit 4 Aims Of Pv
Unit 5 The Scope Of Pv Part 1,2,3
Module 2 2. Signal detection and causality assessment
Unit 1 What Is A Signal, When Does Signal Detection Start & Why Do We Need Signal Detection
Unit 2 Where Can We Find Signals, What Triggers A Signal, How Do We Assess A Signal
Module 3 3. Statistical reasoning and algorithms in pharmacovigilance
Unit 1 Statistical Reasoning And Algorithms In Pv, Dis-proportionality, Relative Reporting Ratio (Rr)
Unit 2 Random Variability, Decision Rules,Aspects Of Strength Of Evidence, A Cautionary Note
Module 4 Medical Dictionary for Drug Regulatory Activities (MedDRA)
Unit 1 Medical Dictionary for Drug Regulatory Activities (MedDRA)
Module 5 Individual Case Safety Reports (Icsrs)
Unit 1 Individual Case Safety Reports (Icsrs)
Module 6 Pharmacovigilance Aggregate report
Unit 1 PV-1.Development Safety Update Report (Dsur)&Benefit-Risk Evaluation Reports (Pbrers)
Unit 2 Aggregate report writing in PV- 2. Dsur And Pbrer(Section1 To Section-5)
Unit 3 Aggregate report writing in PV- 3 Dsur And Pbrer(Section 6 & Section-7)
Unit 4 Aggregate report writing in PV- 4. Dsur And Pbrer( Section 8 To Section-15)
Unit 5 Aggregate report writing in PV- 5. Dsur And Pbrer( Section 16 To 18)
Unit 6 Aggregate report writing in PV-6. Dsur And Pbrer (Section -19)
Unit 7 Aggregate report writing in PV-7. Practice Dsur And Pbrer
Unit 8 Aggregate report writing in PV-8. Periodic Adverse Drug Experience Report (Pader)
Unit 9 Aggregate report writing in PV-9. Risk Management Plan(Rmp)
Module 7 Periodic safety update report (PSUR)
Unit 1 Periodic safety update report (PSUR)
Unit 2 Dsur Vs Psur in Pharmacovigilance
Module 8 Oracle Argus Safety – Theoretical Software Training
Unit 1 Session 2 – Process Of Login, User Interface And Navigation – Oracle Argus Safety
Unit 2 Session 3 – Active Cases And Case Actions In Argus Safety
Unit 3 Session 3.1 – Worklist In Argus Safety
Unit 4 Session 3.2 – Reports Tab In Argus Safety
Unit 5 Session 3.3 – Dashboards And Utilities In Argus Safety
Unit 6 Session 4 – Tabs And Fields Of Case Form & Management Of Cases In Argus Safety
Unit 7 Session 5 – Drug And Event Coding In Argus Safety
Unit 8 Session 6 – Case Management Workflow In Argus Safety
Unit 9 Session 6.1 – Case Processing Of Spontaneous Case In Argus Safety
Unit 10 Session 7 – Overview Of Advanced Conditions And Building Complex Queries In Argus Safety
Unit 11 Session 8 – Aggregate Reporting – Generating Psur In Argus Safety
Unit 12 Session 8.1 – Aggregate Reporting – Clinical Trial Periodic Reports (Ctpr) In Argus Safety
Unit 13 Session 8.2 – Aggregate Reporting – Ind And Nda In Argus Safety
Unit 14 Session 8.3 – Aggregate Reporting – Case Data Analysis, Case Listing, Cioms Ii Line Listing
Module 9 Online Examination
Unit 1 Quiz

CLINICAL DATA MANAGEMENT

Module 1 Introduction to Clinical Data Management
Unit 1 1. Introduction To Clinical Data Management
Module 2 Clinical Data Management
Unit 1 CDMS
Module 3 Medical Coding in Clinical Data
Unit 1 Medical Coding And Medical Dictionaries
Module 4 Clinical Data Process
Unit 1 4. Data Capture
Unit 2 5. Data Collection
Unit 3 6. Data Validation
Unit 4 7. Lab Data Management
Unit 5 8. Query Management
Module 5 Case Report Form
Unit 1 9. Electronic Case Report Form
Module 6 Quality & Regulatory System
Unit 1 11. Regulatory Systems
Module 7 Online Examination
Unit 1 Quiz

FAQs

  1. What is the mode of learning and do I need to visit anywhere to take this course?
    The mode of learning is completely online and you are not to required visit anywhere to take this course. You can easily learn and complete this course from your location. You should have a device (laptop/ desktop) with an internet connection.
  1. How will you deliver the course modules?
    You simply need to log in with your Username and Password at our LMS Portal to start with. The access will be granted to you via email before Course Start Date.
  1. I am a student at present; can I take this course along with my studies?
    Yes, you are eligible to this course along with your regular studies.
  1. Is there any specific timing to take the course modules?
    We have made it very convenient for you. All the course modules are pre-loaded on our website, so you can learn the modules as per your convenient timings.
  1. How will you conduct the exams?
    Exams will be online. Once you are through with course modules and want to take the exams, you just need to drop a request mail at admin@pharma-research.in
    Request to take the online exam can be sent at any time.
  1. When will I receive the Certificate and Performance Card?
    Once you attempt and submit your online exam for evaluation, we generally take 14 working days to evaluate and issue Certificate of Completion along with Performance Card via email.
  1. How will you send the Certificate of Completion?
    The Certificate would be issued through email upon successful completion. The issued certificate would be print-ready but if you wish to receive a hard copy of Certificate then a minimal charge towards processing, printing and courier would be applicable.
  1. How to enroll and pay the fee?
    To enroll, you simply need to view the link HOW TO ENROLL.
  1. Can I pay the fee in installments?
    Yes, you can pay the fee in maximum 3 installments. To pay the fee in installments, you need to contact us at admin@pharma-research.in

You can also view our FAQs page for further queries.

Student 1056

Length: 7 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

Submit your Query !

Testimonials - Happy Learners.

[wprevpro_usetemplate tid=”1″]