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Clinical Research

clinical research1

Clinical Research Courses

In todayโ€™s time when new ailments are being diagnosed among people, the need for medicinal advancement has become a must. To create the right medicine for every ailment needs an expert in clinical research. There is a huge scope for those who have a certification in Clinical Research and job opportunities that offer attractive salaries both in India and in abroad.
Our Professional Certification in Clinical Research course opens the opportunities for you, in the field of clinical research.

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

 

Eligibility: Life science/ Medical/ Pharma graduates and post graduates

Duration: 2 – 3 months theoretical (self paced)+ 3 months internship*

 

Course Curriculum:

  • Introduction to Clinical Research
  • Evolution of GCP
  • Principles of GCP + Practical Application + Case Studies
  • Phases of clinical trials and drug development process
  • Medical terminologies in clinical research
  • Drug & Cosmetic Act 2019ย 
  • Informed Consent, Elements and Documentation
  • Essential documents in clinical research
  • Source Documentation
  • Overview of Trial Design and Protocol Writingย 
  • AE / SAE Reporting
  • Fundamentals of Clinical Data Management
  • Fundamental of Pharmacovigilance

* Internship opportunity: Offered to selected students who excel in the exams.

 

Other benefits:

  • Notesย 
  • Regular doubt clearing sessions
  • Periodic revision
  • 100% placement assistance

 

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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of appropriate data.

 

Eligibility:

  • Life Science/Medical/Pharma Graduates
  • Candidates with more than six months experience in Clinical Research can directly apply for Advanced Clinical Data Management module of 3 months

Duration: 5 – 6 months (self paced)

 

Course Curriculum:ย 

 

Entire course curriculum of the Clinical Research course + Clinical Data Management courseย 

 

Clinical Data Management course curriculum:

  • Medical Writing: Trial design
  • Protocol Writing Theory
  • Medical Writing: Protocol Writing-2 [Practical]
  • Medical Writing: CRF design
  • Medical Writing: e CRF design + Practical
  • CDM Theory: Overview of Clinical Data Management (CDM)
  • CDM Theory: Study startup
  • CDM Theory: Study Conduct
  • CDM Theory: Study Closeout
  • CDM Theory: Discrepancy Management+GCDMP+21CFR
  • CDM Practical: Data entry in eCRF solution
  • CDM Practical: Double Data entry in eCRF solution
  • CDM Practical: Query raising
  • CDM Practical: Query resolution + Source Data verification

 

Other benefits:ย 

  • Notesย 
  • Regular doubt clearing sessions
  • Periodic revision
  • 100% placement assistance

 

 

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Pharmacovigilanceย (PVย orย PhV), also known asย drug safety, is theย pharmacologicalย scienceย relating to theย collection, detection, assessment, monitoring, and preventionย ofย adverse effectsย withย pharmaceutical products.

 

Eligibility:

  • Life Science/Medical/Pharma Graduates
  • Candidates with more than six months experience in Clinical Research can directly apply for Advanced Pharmacovigilance module of 3 months

Duration: 5 – 6 months

Course Curriculum:

 

Entire course curriculum of the Clinical Research course + Pharmacovigilance courseย 

 

Pharmacovigilance course curriculum:

  • General Overview of Pharmacovigilance
  • PV – Basic principles of PV and AE / ADR reporting systemย 
  • Global Pharmacovigilance Regulatory Requirements in Pharmacovigilanceย 
  • Safety Data Management
  • Safety Data Reporting
  • General Overview of GVP
  • Quality in Pharmacovigilance
  • Safety Signal Management
  • Drug Safety in Clinical Trialsย 
  • Overview of Safety Database and forms used in the actual scenario

 

Other benefits:

  • Notesย 
  • Regular doubt clearing sessions
  • Periodic revision
  • 100% placement assistance

 

 

Register Now

Clinical Research Course
Clinical research course
  • **conditions apply
  • **Rights of admission are reserved
  • **JCL is not affiliated to any university. Courses offered by JCL are autonomous & not approved by AICTE