The document outlines key terms related to clinical research, including definitions of clinical research, clinical trials, hypothesis, and informed consent. It discusses various participant roles such as healthy volunteers and patient volunteers, as well as important concepts like randomization, placebo, and study endpoints. Additionally, it describes the responsibilities of the principal investigator and the roles of sponsors and collaborators in clinical studies.

1. Clinical Research
Terms
Dr. Chavan P. R.
Pharm D

2. Clinical Research
 Clinical research is medical research that
involves people to test new treatments and
therapies.

3. Clinical Trial
 A research study in which one or more human
subjects are prospectively assigned to one or
more interventions (which may include
placebo or other control) to evaluate the
effects of those interventions on health-related
biomedical or behavioral outcomes.

4. Hypothesis
 A supposition or assumption advanced as a
basis for reasoning or argument, or as a guide
to experimental investigation.

5. Healthy Volunteer
 A Healthy volunteer is a person with no known
significant health problems who participates in
clinical research to test a new drug, device, or
intervention.

6. Investigational drug
 The drug being evaluated in the trial; this
definition is synonymous with “investigational
new drug” or “investigational medicinal
product.”

7. Inclusion/Exclusion Criteria
 Inclusion/Exclusion Criteria are factors that
allow someone to participate in a clinical trial
are inclusion criteria.
 Those that exclude or not allow participation
are exclusion criteria.

8. Informed Consent
 Informed consent explains risks and potential
benefits about a clinical trial before someone
decides whether to participate.

9. Patient Volunteer
 A patient volunteer has a known health
problem and participates in research to better
understand, diagnose, treat, or cure that
disease or condition.

10. Baseline
 Information gathered at the beginning of a
study from which variations found in the study
are measured.
 Initial time point in a clinical trial, just before
a participant starts to receive the experimental
treatment that is being tested.

11. Arm
 Any of the treatment groups in a randomized
trial. Most randomized trials have two “ arms, ”
but some have three “ arms, ” or even more.

12. Phases of Clinical Trials
 Categories, defined by the Food and Drug
Administration (FDA), for describing the
clinical trial of a drug based on the study's
characteristics, such as the objective and
number of participants.

13. Placebo
 A placebo is a pill or liquid that looks like the
new treatment but does not have any
treatment value from active ingredients.

14. Protocol
 A Protocol is a carefully designed plan to
safeguard the participants’ health and answer
specific research questions.

15. Study endpoint
 A primary or secondary outcome used to
judge the effectiveness of a treatment.

16. Principal Investigator
 A Principal Investigator is a doctor who leads
the clinical research team and, along with the
other members of the research team, regularly
monitors study participants’ health to
determine the study’s safety and effectiveness.

17. Sponsor
 The Sponsor is the organization or person who
oversees multiple sites conducting the clinical
trial.

18. Collaborator
 An organization other than the sponsor that
provides support for a clinical study.
 This support may include activities related to
funding, design, implementation, data
analysis, or reporting.

19. Randomization
 Randomization is the process by which two or
more alternative treatments are assigned to
volunteers by chance rather than by choice

20. Single- or Double-Blind Studies
 Single- or double-blind studies (also called
single- or double-masked studies) are studies
in which the participants do not know which
medicine is being used, so they can describe
what happens without bias.

21. Thank you