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1What are the Courses IGCP is providing?
  • Clinical Trials/ Clinical Research
  • ICH GCP Guidelines
  • Clinical Data Management
  • Pharmacovigilance
  • Medical Writing/Coding
  • SAS
  • TLF’S
2What is Clinical Research?

A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.

3Is Clinical Trials same as Clinical Research?

Yes, the term clinical trials also refer to clinical research.

4How a Clinical Trial is conducted?

A clinical trial is conducted in a phase-wise manner. There are four phases of a clinical trial (I,II, III, and IV) each designed to address different questions. The knowledge gained from one phase is assessed before progressing to the next phase. Phase-I clinical trials are generally done to establish the initial safety of a drug usually on healthy human volunteers. Phase-II and Phase- III clinical trials are done to establish the safety and efficacy of a drug in patients with relevant indication.Phase-IV clinical trials are post marketing studies done to collect the additional safety data on a drug after its marketing authorization.

5Describe the phases of clinical trials?

Ans :- These are the following four phases of the clinical trials:
Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety.
Phase 2: The experimental drug or treatment is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.
Phase 3: The experimental drug or treatment is given to a large group of people (1000-3000) to see its effectiveness, monitor side effects and compare it to commonly used treatments.
Phase 4: The 4 phase study includes the post marketing studies including the drug's risk, benefits etc.