it talks about the basics of clinical research, describing the common terms used related to it

1. Clinical Research:
Introduction and Ethics
Presented by- Submitted To-
Bhavya Rewari Mrs. Jyothi Y.
M.Pharm, 1st year Asst. Prof.
Dept. of Pharmacology Dept. of Pharmacology
Krupanidhi College of Pharmacy
Bangalore

2. Contents
• Definition and Scope of clinical research
• Role of sponsor
• Study director or principal investigator
• Clinical Research Associate in conduct of
Clinical Research

3. Clinical Research
• Clinical research is a branch of healthcare science that
determines the safety and effectiveness 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

4. Clinical Research
• According to the International Conference on
Harmonization (ICH), the definition of a clinical trial or
study is as follows:
Any investigation in human subjects intended to discover
or verify the clinical, pharmacological and/or other
pharmacodynamic effects of an investigational
product, and/or to identify any adverse reactions to an
investigational product, and/or to study
absorption, distribution, metabolism, and excretion of an
investigational product with the object of ascertaining its
safety and/or efficacy.

5. Clinical Research
• The National Institutes of Health defines “clinical research”
as research conducted with human subjects for which an
investigator (or colleague) directly interacts with human
subjects
• Excluded from this definition are in vitro studies that
utilize human tissues that cannot be linked to a living
individual
• Clinical research includes:
Patient-oriented research – This type of research
involves a particular person or group of people, or uses
materials from humans.

6. Clinical Research
This research can include-
1) mechanisms of human disease
2) therapeutic interventions
3) clinical trials
4) development of new technologies
• Epidemiological and behavioral studies – These types
of studies examine the distribution of disease, the factors
that affect health, and how people make health-related
decisions

7. Clinical Research
• Outcomes and health services research – These
studies seek to identify the most effective and most
efficient interventions, treatments, and services

8. Role of a sponsor
• Sponsor is an individual, company, institution, or
organization which takes responsibility for the initiation,
management, and/or financing of a clinical trial
• This is the organization or individual that initiates the
clinical trial and finances the study
• The organization may be a government department,
pharmaceutical company, university, or individual

9. Role of a sponsor
• Sponsor team contain following-
Project Manager
CRA/Monitor
CRO (Contract Research Organization)
Data Manager
Biostatician
Medical Writer

10. Role of a sponsor
• Responsibilities of sponsor:
Selection of Site and Investigator
Sponsor responsibility is to select well qualified, trained
and experienced investigator(s) for the conduct of
trial.
The selected investigator should be based at the
institutions/hospitals having sufficient resources to
properly conduct the trial

11. Role of a sponsor
Allocation of Duties and Responsibilities
Prior to initiating a Study the Sponsor should define and
allocate all Study related duties and responsibilities to the
respective identified person(s)/organization(s)

12. Study director or principal
investigator
• The Investigator is the person who conducts the trial
• If there is a team in the investigation, then there is a
Principal Investigator
• This person is normally an expert in the field of the
disease to be investigated
• The Investigator ’ s responsibility is to ensure that GCP is
being implemented during the course of the trial and the
subjects ’ rights and welfare are respected
• Another important point is that the Investigator has to
maintain impartiality

13. • He/she is not an employee of the company (the Sponsor
where the drug is developed), to show that there is
transparency and no conflict of interest, nor is there
financial gain if the drug is successful

14. References
• DRUGS-From Discovery to Approval, Second
Edition, by RICK NG
• http://keck.usc.edu/Research/Clinical_Researc
h/Definition.aspx
• http://en.wikipedia.org/wiki/Clinical_research
• http://www.slideshare.net/santoshzarkariya/spo
nsor-responsibilities-ppt