Clinical Research
What Clinical Research?
Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. … Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients.
Materials :
Books and Daily notes will be provided by us along with that recording also will be provided for reference . Step by step notes will be provided and excersises also.
Sample Videos : We request you that first don’t join the course directly as we provide the sample videos in the cirriculam first watch that try to understand. If you understand and feel comfortable with trainer explanation then gohead for classes. Join the course.
Working hours : 9:00 am ist to 8 pm ist .
Introduction to Clinical
INDA
NDA
ANDA applications
Types
Designs
Fundamentals of Trial Design
Alternative Trial Designs
Clinical Research Methodology
ICH GCP guidelines (ICH E6)
Roles and Responsibilities of Investigator and CRA
Roles and Responsibilities of Sponsor and CRC
Contract Research Organizations-CRO
Case Report Form and its Contents with live example
Contents of protocol
Explanation of Research protocol with live example
Informed Consent Form
Institutional Review boards(IRB)/IEC
Participant safety and Adverse events reporting
Participant safety and Adverse events reporting
Monitoring of Study at participating sites
Source Data Verification
Investigator's Brochure (IB)
XIX. Standard operating procedures
Essential documents
Data Coding using MedDRA and WHODD
CRF Design Guidelines
SAE/AE Reconciliation
Productivity Hacks to Get More Done in 2018
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