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clinical research
Clinical Data Management

PVCR102: Advanced PG Diploma in Clinical Research & Clinical Data Management

6 Months Certification Program

FEE: 15999/-

To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.

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About this course

Clinical Research

The demand for clinical trials is expected to hit a market value of $64B by 2020 compared to the present value of $38.4B. The market is expected to reflect CAGR at 9% between 2015 and 2020. Currently, ClinicalTrial.gov lists more than 200,000 trials worldwide, creating a number of career options for clinical trial operations and related fields. The Professional Certification in Clinical Research (PCCR) & CDM course allows learners to gain in-depth knowledge of the relevant ICH-GCP and regulatory requirements, clinical trial study methods, duties and responsibilities of various stakeholders, reporting procedures, terminology, etc. This course will allow clinical research candidates and working professionals to succeed in their careers as Clinical Trial Operations Coordinator (CRC), Clinical Research Associate or Clinical Trial Investigators.

Clinical Data Management
Clinical Data Management Course equips you with the knowledge and skills needed for making a successful career. Clinical Data Management (CDM) is an important stage in Clinical Research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management helps collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research. This program will help you to understand the technical part of Clinical Data Management process. What you’ll learn Become a Clinical Data Management Professional and work with world’s leading Contract Research Organisations. Are there any course requirements or prerequisites? A Life Science professional willing to work for Clinical Data Management sector Who this course is for: Life Science, Pharma or Medical Graduate, Clinical Research and IT Professionals


Who Should Take This Course?

  • Clinical Research Professionals
  • Aspirants (students/ working professionals) from 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?

  • 12 high-quality learning modules with an online exam.
  • In-depth knowledge in applicable ICH-GCP and regulatory guidelines.
  • Learn various clinical trial study processes.
  • Learn roles and responsibilities of clinical trial personnel.
  • Certificate and Performance Card on successful completion.
  • Opportunity to explore your career in Clinical Research Operations.
  • In-depth training and guide on Clinical Data Management

International authors Clinical research, Phamacovigilance & Clinical Data Management eBooks lifetime accessibility

CLINICAL RESEARCH

  1. Introduction to Clinical Research & Good Clinical Practice
  2. Overview ICH GCP
  3. Good Clinical practice
  4. Clinical Trails
  5. Institutional Reviews board
  6. Investigation Responsibilities in clinical trails
  7. Roles and Responsibilities of Sponsor & Clinical Trial Monitor
  8. Informed Consent Process
  9. Serious Adverse Event (SAE), Adverse event reporting
  10. Site Initiation visit
  11. Site close visit
  12. Test Your Self
  13. Apply Your Certificate

CLINICAL DATA MANAGEMENT

Module 1 Introduction to Clinical Data Management
Unit 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 Data Capture
Unit 2 Data Collection
Unit 3 Data Validation
Unit 4 7. Lab Data Management
Unit 5 Query Management
Module 5 Case Report Form
Unit 1 Electronic Case Report Form
Module 6 Quality & Regulatory System
Unit 1 Regulatory Systems

– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.

  1. What will be 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 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 internet connect.
  1. How will you deliver the course modules?
    You simply need to log in with the Username and Password at our Online Moodle Portal to start learning. The access will be granted to you via email within 24 hrs. of fee payment.
  1. I am a student at present; can I take this course along with my studies?
    Yes, you can take 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 the 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 examination, you just need to drop a request mail at info@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 7 business days to evaluate and issue Certificate of Completion along with Performance Card
  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 info@pharma-research.in

You can also view our FAQs page for further queries.

Student 3200

Length: 4 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

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