Salient Features of the Course: This course will provide an opportunity for the Life Science/Science Students to learn online about Clinical research as a science, basic terminologies used in these fields, methods, Reporting systems & Regulatory aspects, At the completion of all modules, Students will be assessed through written & oral examinations, also through the assignments. COURSE OUTCOME: After Completion of the Course Trainees will be able to 1. Explain overall process of Clinical Research 2. Remember various Regulatory Agencies and their norms 3. Make a career in CR Industry Ø Duration of Corse: 3 Months Ø Classes on Saturdays & Sundays Ø If Required More Classes can be taken Ø Certification after successful assessment post finishing following Modules · Module 1. Introduction to Clinical Research 6Hrs

ü Introduction Drug Discovery & Development Process ü History of Clinical Research
ü Clinical research its need & Career prospects ü Indian scenario

ü Module 2. Pharmaceutics & Pharmacology 4Hrs

ü Intro to Pharmacology ü Pharmacokinetics ü Pharmacodynamics
ü Dosage Forms & Route of Drug Administration

· Module Preclinical Stage of Drug Development 4Hrs ü Safety Assessment ü Efficacy Assessment · Module 4. From Lab to Human Trial 8Hrs

ü IND Submission ü Phase I & II ü Phase III
ü NDA Submission ü Phase IV

· Module 5. Regulations in Clinical Research 8Hrs

ü Drugs and Cosmetics Act 1940 & Corresponding Rules ü Schedule 'Y'
ü International regulatory Agencies (USFDA; EMEA; & Japan) ü ICH-GCP

· Module 6. Clinical Trials Documents and Development 8Hrs

ü Essential Documents ü Protocol ü Case Report Form
ü Investigator Brochure ü Clinical Study report

· Module 7. Pharmacovigilance 8Hrs

ü Introduction to Pharmacovigilance ü Adverse Event and Serious Adverse Event Reporting
ü Safety Reporting ü Periodic Safety Updates Reports

· Module 8. Quality Control and Quality Management in Clinical Research 6Hrs

ü Standard Operating Procedures ü Audits & Inspection
ü Misconduct and Fraud

· Module 9. Clinical Data Management 8Hrs

ü Clinical data Management Overview ü Data Entry ü Data Base Concepts
ü Data Validation ü Query Management

· Module 10. Clinical Trials Management 8Hrs