This is my 43rd powerpoint......on GCP Guidelines ..... It gives an introduction about GCP guidelines, the rules involved, with appropriate references.... Happy Reading!

2.  International quality standard, provided by ICH
 GCP  enforces tight guidelines on ethical aspects of a clinical study
 Provides standards for the following aspects of a clinical trial:
a. Design
b. Conduct
c. Performance monitoring
d. Auditing
e. Recording
f. Analysis
g. Reporting.

3.  GCP guidelines  provide assurance that:
a. Data & results are credible & accurate
b. Rights, integrity & confidentiality of trial subjects are maintained
c. Newly developed compounds  are safe & efficacious.

4. A. 2.1 :
- Clinical trials  should be conducted in accordance with ethical principles (as
elucidated in Declaration of Helsinki)
- Trials should be conducted in harmony with GCP & other applicable regulatory
requirements.
B. 2.2 :
- Before a trial is initiated, focus on risk vs benefit ratio
- Foreseeable risks & subject inconveniences  should be weighed against
anticipated benefits for the trial subject & society.
- Trial should be initiated & continued only if anticipated benefits outweigh risks.

5. C. 2.3:
- Consider the following aspects of trial subjects as paramount, which should
prevail over interests of science & society:
a. Rights
b. Safety
c. Well-being.
D. 2.4:
- Existing/ available non-clinical & clinical informations with respect to an
investigational product  sufficient enough to conduct the proposed clinical trial.

6. E. 2.5:
- Clinical trials should be :
a. Scientifically sound
b. Described in a clear, detailed protocol.
F. 2.6:
- Trial  should be conducted in compliance with the protocol, that has been
approved by IRB/IEC.

7. G. 2.7:
- A qualified physician  responsible for the following aspects of trial subjects:
a. Medical care
b. Medical decisions made on behalf of the trial subjects.
H. 2.8:
- Each individual conducting the clinical trial  should be qualified by education,
training & experience, in order to perform his/her respective tasks.

8. I. 2.9:
- Freely given informed consent  should be obtained from every subject prior to
clinical trial participation.
J. 2.10:
- All clinical trial information  should be recorded, handled & stored in a way,
such that it can help in accurate reporting, interpretation & verification.
K. 2.11:
- Confidentiality of records (that help in subject identification)  should be
protected, in accordance to applicable regulatory requirements.

9. L. 2.12:
- Investigational products  should be manufactured, handled & stored, in
accordance with applicable GMP guidelines.
- Investigational products  should be used in accordance with approved protocol.
M. 2.13:
- Systems with procedures that assure quality of every aspect of the trial should be
implemented.

10. 1. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products_Guide
lines/Efficacy/E6/6_R1_Guideline.pdf
2. Malaysian Guidelines for Good Clinical Practice. 2nd edition.
Ministry of Health Malaysia; 2004.
3. Otte E, et al. Good Clinical Practice: Historical background and key
aspects. 2005;26:563-74[PubMed].

11. THANK YOU!!!