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Become a Certified Clinical Research Professional (CCRP)

Join in Global Largest Clinical Research Certification Program

Scope of Clinical research: There is a huge growth in scope and career in clinical research these days. Any student with any education al background can pursue their career in Clinical research. There are bulks of jobs for the students after the completion of the course. For example one can opt for career as a Clinical Research Coordinator, Business Development, Medical Writer, Regulatory Affairs, Regional CRA, Senior CRA, pharmacovigilance, Clinical data manager and many more Beginners can earn around Rs.15000 per month and after 2 to 3 years of experience one can draw salary at Rs.4 to 5 lac per annum package. Statistics reveal that by 2008 up to 30% of the global clinical trial will take place outside Us and Europe and India is a favored destination, Clinical research professional has the potential to take a highly paying job, compared to other industries. Clinical research is big revenue earner for the country. It is estimated to grow into US$ 1 billion strong industry in India by 2010 with 50000 clinical research jobs in India and 2,50,000 jobs worldwide.

Scope of Clinical research in Asia, Africa & EU Countries : Over the last three years, around the Asia, Africa & EU Countries now becoming a favored destination for the clinical traits because of development of new medical institutions, the amount of man power we have and due to the existence of large variety of diseases such as cancer, diabetes etc. Reports reveal that India is the second largest pharmaceutical market in Asia. Indian market is growing by more than 9% annual. India is now becoming a clinical research hub because of cost effectiveness. R&D costs in India are much less than those in the developed world and it are possible to conduct new drug discovery research at competitive rates. There are over 300 CRO’s operating in India. The major problems faced by these organizations are the lack of Clinical research professionals to carry out the Clinical trial activities. As a result of a huge demand, the decline rate in the industry is as high as 40%. There is a requirement of about 50000 professionals by 2010.

Scope for life science and Pharma students in clinical research: An understanding of the fundamental principles of biology is very essential for the Clinical research. Life science students involve in many experimental techniques, use instruments and reagents. Hence this research can generate new hypothesis and propel in new studies. So many life science and pharma graduates are being absorbed in many Pharma companies where Clinical trials are conducted.

Scope for doctors, physicians in Clinical research: Not only does the Life science students gain jobs in Clinical research field, but also doctors, physicians etc. For example a doctor can administer the right drug to patient at right times and he knows what is the dose required for a particular patient. They also have a good understanding on the chemistry of the disease. Thus Clinical research is an equal opportunity provider for all the students pursued their education in either of the fields.

CCRP

About this course

CCRP, Global Largest Clinical Research Certification Program

  • One certification, SCRP- CCRP, for clinical research professionals: No need to obtain multiple certifications when you transition to varying roles in the clinical research arena. The scope of the Certification Program is based on the principles of Good Clinical Practice, including the US Code of Federal Regulations, ICH GCP E6, and the Ethical Principles that guide clinical research (Belmont report, Declaration of Helsinki and the Nuremberg Code).
  • One certification covers: human clinical research of pharmaceuticals, biologics, medical devices and behavioral research within the US or internationally.
  • Available to members and non-members: If you are already a SCRP member, your certification is offered at a reduced cost. If you are not a member, you receive complimentary membership when you pass the exam.
  • Available to all persons working in clinical research (whether you are independent or affiliated with a research institution, CROs, SMO, sponsor, or government) including: 

Clinical investigators, coordinators, data managers, monitors, auditors, research nurses, pharmacists, project managers, statisticians, IRB and regulatory staff, regulators and government investigators, other clinical research professionals, Year-round testing available:

SCRP Sponsored Exams:  Computer Based Testing – Testing Centers or New! Home Proctoring,  Host an exam at your site

  • Administered independently by the Certification Committee: As a professional certification organization, SCRP and its Certification Committee act in the public interest by establishing and enforcing education, examination, experience and ethics requirements for certification.
  • Eligibility: There are multiple ways to qualify for the exam through your professional and educational experience.
  • CCRP Certification period: Your CCRP certification period is 3 years (with three year installment plan available).
  • Recertification: Maintain your certification through your professional experience and continuing education. Certificants must have completed 45 hours (45 credits) of CE during their certification period.

 

  • Administered independently by the Certification Committee: As a professional certification organization, PHARMA RESEARCH- SCRP and its Certification Committee act in the public interest by establishing and enforcing education, examination, experience and ethics requirements for certification.

 

  • Industry Recognized and Accredited:

PHARMA RESEARCH SCRP is accredited by International Accreditation Council for Clinical Research & Education (IACCRE) for demonstrating compliance with the IACCRE Standards for the Accreditation of Certification Programs.
TransCelerate BioPharma recognizes the SCRP- CCRP designation as evidence of Good Clinical Practice (GCP) training.

Module-1 : Clinical Research

  • Introduction to Clinical Trails ,
  • Overview ICH GCP
  • Investigation Responsibilities in clinical trails
  • Roles and Responsibilities of Sponsor & Clinical Trial Monitor
  • Informed Consent Process
  • Serious Adverse Event (SAE),
  • Adverse event reporting
  • Site Initiation visit, Site close visit

Module-2 : Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Signal Detection and causality assessment
  • Statistical reasoning and algorithms in pharmacovigilance
  • Medical dictionary for Drug Regulatory Activities (MedDRA)
  • Individual Case Safety Report (lcsrs)
  • Periodic Safety update report (PSUR)

Module-3 : Drug Regulatory Affairs

  • Overview of Regulatory Environment in India, US, Aus, EU
  • Clinical Trial Requirement in India
  • Import-Export of Clinical Trial Drugs
  • HIPAA Privacy Rule
  • INDIA/ANDA/New Drug Application

Module-4 : Clinical Data Management

  • Introduction to Clinical Data Management
  • Clinical Data Management
  • Medical Coding in Clinical Data
  • Clinical Data Process
  • Case Reporting Form
  • Quality & Regulatory system

– 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.

CCRP

Certified Clinical Research Professional

Duration: 6 Months

Fee: ₹ 19999/-

For Admission & Registration

INTERNATIONAL STUDENTS – PAY through PAYPAL


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