Dual Certification in Clinical Research and Clinical Data Management (DCCRCDM)

INDUSTRY OVERVIEW

With the globalization of clinical research and advancement in technologies clinical research and clinical data management are the two major growing sectors over the past 5 to 7 years. When the worth of global clinical research market has reached to US$ 64 billion with more than 155000 trials till date, clinical data management is also predicted to reach US$ 1.37 billion in 2015.

Low cost, higher recruitment rate, sound infrastructure, large population size, qualified professionals are the driving factors to shift the focus of clinical research and clinical data management towards countries like India, China, Brazil, Russia etc. India is expected to conduct 5% of clinical trial (currently 2600+ trials) and worth of clinical data management is estimated to US$60 million. This tremendous growth has resulted in requirement of large number of trained and qualified manpower from health sciences domain.

LEARNING OBJECTIVES

  • To impart clear understanding on various essential elements of Clinical Research and Clinical Data Management.
  • To provide theoretical knowledge on various essential CDM topics: Regulatory Guidelines, CDM workflow, Data Management Plan etc.
  • To provide theoretical knowledge on various essential CR topics: Drug Discovery, Regulatory, GCP, Ethics etc.
  • To train you on different aspects and activities involved: CRF Designing, Data entry, Data Collection, AE Management, and Report Creation etc.
  • To train you on different aspects and activities involved during a clinical trial: Informed Consent, SAE Reporting etc.
  • Roles and Responsibilities CR and CDM personnel along with its application required to execute at various levels.

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Curriculum

Module1: Clinical Research

  • Introduction to Clinical Research and Clinical Data Management
  • Ethics in Clinical Research
  • Roles & Responsibilities of Clinical Research Personnel
  • Guidelines & Regulation Associated with Clinical Research
  • Essential Clinical Trial document
  • Importance of Informed Consent Documentation
  • Importance Safety Reporting
  • Recent Trends in Clinical Research
  • Careers in Clinical research
  • Clinical Research Glossary & Common Abbreviation

Module 2: Clinical Data Management

  • Clinical Data Management and Clinical Information Flow
  • Roles & Responsibilities of CDM Personnel
  • Guidelines Associated with CDM
  • Data Management Plan
  • CRF Designing
  • Data Entry, Collection, cleaning and validation
  • Study Setup & Database Designing
  • Laboratory Data & AE Management
  • Report Creation & Data Closure
  • Data Archiving, Privacy & Security 

Eligibility

  • Pharmacy Students (Pursuing or completed): B.Pharm, M.Pharm
  • Life-Sciences Students (Pursuing or completed): B.Sc, M.Sc
  • Medicine Students (Pursuing or completed): BDS, MDS, MBBS. M.D., M.S, MCh
  • Alternative Medicine (Pursuing or completed): Ayurveda, Unani, Yoga, Siddhi, Homeopathy, Traditional Medicine etc.
  • Nursing (Pursuing or completed): B.Sc., M.Sc.
  • Industry Personnel
  • Clinical Research Personnel: CRC, CRA, CTA, Clinical Trial Investigators
  • Computer Sciences/ IT candidates
  • PhD

Online Enrollment Procedure

Step 1

Click button Enroll Online and then Click Checkout button

Step 2

Complete and submit the Registration Form, followed by Checkout button

Step 3

Choose convenient Mode of Payment and Make the Payment

Step 4

Get Instant Access* to Login Details along with Study Material & Assignment.

*Instant access is applicable only to participant who have selected online mode of learning. For offline (distance) mode of learning, the study material and assignment will be dispatched to their corresponding address on the last date of registration of that batch.



Offline Enrollment Procedure

Step 1

Download the Offline Enrollment Form present on respective pages of courses

Step 2

Send the completed enrollment form along with the fee (details mentioned on enrollment form) on our official address

Step 3

Dispatch of course material along with assignment on your corresponding address.

Course FAQs

What is Clinical Data Management (CDM) or Clinical Trial Data Management (CTDM)?

CDM is an activity performed during the clinical trial to maintain and manage the planning, preparation, performance, and reporting of clinical trials, with emphasis on tracking participants, deadlines and milestones. The systems are used by Sponsor companies to manage the large amounts of data involved with the operation of a clinical trial.

What is Clinical Research?

“Clinical research is a branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use” or “We can say that clinical research is an important part of the drug/device discovery and development to ensure that the drug/device to be marketed is safe and effective on human usage”.

What are the career opportunities in CDM after completing DCCRCDM Training?

The career opportunities after DCCRCDM are as follows:

Clinical Data Coordinator, Clinical Data Associate, Data Validation Executive, QA Executive, Data Manager, Data Reviewer, Data Base Designer/Programmer.

What is the career growth in Clinical Research industry after completing DCCRCDM Training?

The career growth in CR industry is as follows:

Physicians:Principal Investigator, Co-investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager and Clinical Research Physician etc. 

Others:Clinical Research Coordinator (CRC)/ Clinical Research Associate (CRA) >> Sr. CRA >> Project Manager >> Team Leader >> Operations Manager >> Director

Why should I pursue this course?

CPCDM will offer you following inherent advantages to excel your career growth by:

  • providing an in-depth knowledge of Clinical Research and Clinical Trial Data Management essential elements.
  • increasing the visibility of your CV among potential recruiters
  • Increase the acceptance in companies’ for jobs against non DCCRCDM candidates.
  • An opportunity to explore career in two domains simultaneously as CRC/ CRA in clinical research or Clinical Data Coordinator/ Data Validation Executive in CDM.

Where I can apply after completing DCCRCDM course?

After successfully completing DCCRCDM course, one can explore career in CDM and CR companies as:

Clinical Data Coordinator/ Data Validation Executive with Pharmaceuticals, IT Companies, KPOs, CROs, SMOs, Clinical Trial Consulting companies etc.

Clinical Research Associate/ Clinical Research Coordinator (CRC) with Sponsor Companies (Pharmaceuticals/ Biotech), Hospital Sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), Research Institutions etc.

For more details on courses, fees, enrollment, Result, Assignments, Certificates, Placements visit our General FAQs section.

Course Code : DC-201-01
Level : Beginner
Mode of Learning : Online/ Distance
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 14500
Current Batch : May'16 (Till 31st)
Duration : 24 weeks

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