1. GCP (GOOD CLINICAL PRACTISE)

2. History of Good Clinical Practice
Prior to an actual set of guidelines to follow for good clinical practice, clinical studies were dangerous and could result in serous disease, or possibly death.
The Nuremburg Code of 1947
Experiments performed in Germany during WWII opened the eyes of the world for guidance for clinical testing on humans. The code did set ethical guidelines, but it lacked legislation to back it up.
Declaration of Helsinki
In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. These guidelines influenced national legislation, but there was no set standard between nations.

3. Quality Data + Ethics = GCPs
DEFINITION
Good Clinical Practice (GCP) is defined as a ‘standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected’
Quality Data + Ethics = GCPs

4. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human patients.
Compliance with this standard provides public assurance that the rights, safety and well-being of trial patients are protected and clinical trial data are credible.

5. FOCUS
Are mainly focused on the protection of human rights in clinical trial.
Provide assurance of the safety of the newly developed compounds.
Provide standards on how clinical trials should be conducted.
Define the roles and responsibilities of -
Clinical Sponsors,
Clinical Research Investigators,
Clinical Research Associates, And
Monitors.

6. Elements of GCPs IRB/IEC Investigator Sponsor
Clinical trial protocol and protocol amendment(s)
Investigator’s brochure

7. ICH Guidelines are divided into 4 main topics:
Quality Topics – relate to chemical and pharmaceutical quality assurance
e.g. Q1 Stability Testing
Safety Topics – relate to preclinical studies
e.g. S1 Carcinogenicity Testing
Multidisciplinary Topics – cross-cutting topics
Efficacy Topics – relate to clinical studies in human subjects
e.g. E6- Good Clinical Practice;
e.g. E2A- Clinical Safety Data Management:
e.g. E9 -Statistical Principles for Clinical Trials

8. Essential Documents Study protocol with all amendments
Signed consent form for all subjects
IRB submission forms/approval memo(s)
All versions of consent form
Samples of all recruitment advertisements
For all investigational drug studies
Investigator’s brochure

9. GCP – Benefits and Risks
International acceptance of studies
Clarified responsibilities
Research is more acceptable to patients, clinicians etc.
Avoidance of wasteful research
Standardized procedures
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject & society.
Benefits
RISKS

10. Importance of ICH-GCP guidelines
Protection of clinical trial subjects
Ensuring ‘good’ science
Avoiding unethical processes
Applicability across geographical locations
Ensure ‘quality of care’
Data accuracy and reliability
Prevention of data alterations
Sets a benchmark for global clinical trials
Will permit modification of regulatory procedures wherever deficient or inconsistent with ethics & GCP. Aimed at improving clinical development process

12. Principles of ICH GCP Conduct trials according to GCP
Weigh risks vs. benefits
Protect the subjects
Have adequate information to justify trial
Write a sound protocol
Receive IRB/IEC approval
Use qualified physicians
Use qualified support staff
Obtain informed consent
Record information appropriately

13. Protect confidentiality
Handle investigational products appropriately
Implement quality systems
May have more detailed regulations that apply locally
Do not conflict with national regulations
Standard Operating Procedures (SOPs)-Detailed instructions describing the what, when, where, and by whom of performing an activity

14. Institutional Review Board (IRB), Independent Ethics Committee (IEC)
A formally designated group that oversees research involving human subjects.
Approves and disapproves human subject research.
According to the standards of the community or the institution, the IRB/IEC may require modifications to a protocol to ensure patient safety.

15. The primary function of an IRB/IEC is to safe guard the rights ,safety ,and well being of all trial subjects. This is accomplished by initial, continuing and annual review.
An IRB should consist of members who collectively have the qualifications and experience to review and evaluate the science , medical aspects, and ethics of the proposed trial.
All studies must be approved prior to recruiting participants
IRB must review all documents given to participants
Reporting AEs and Deviations from protocol to the IRB
Maintenance of Records

16. Investigator Responsibilities
Adequate Resources
Recruitment
Time
Qualified Staff
Facilities
Training
Medical Care
Compliance with Protocol
Progress Reports
Safety Monitoring
Final Reporting

17. Clinical Trial Protocol
General Information
Background Information
Trial Objectives & Purpose
Trial Design
Selection & Withdrawal of Participants
Treatment of Subjects
Assessment of Efficacy
Assessment of Safety

18. Sponsor Responsibilities
Trial Design
Trial Management, Data Handling, Recordkeeping, & Independent Data Monitoring Committee (DMC)
Qualified personnel to supervise overall conduct of the study
DMC assesses the progress of the clinical trial
Maintain SOPs for electronic data processing
Inform Investigator of guidelines for record retention

19. Essential Documents for the Conduct of a Clinical Trial
Preclinical trial commencement
During clinical conduct of trial
After completion or termination of trial

20. REFERENCES http://www.fda.gov/oc/gcp/guidance.htm
Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development -2nd ed., WHO Library Cataloguing-in-Publication Data, 2nd ed., 7,15-20.