To learn the applications of Good Clinical Practice (GCP) in clinical research.
ICH-GCP Guidelines are international standards of ethical and scientific consistency for the preparation, implementation, monitoring, evaluation, analysis, review and reporting of biomedical and behavioral research in the human population. Good clinical practice provides a framework of principles aimed at ensuring the safety of research participants and the integrity and validity of the data. The guideline came into force in 1997 as a guide by a steering group called the Tripartite International Harmonization Council (ICH) which included the regulatory agencies of the three major regions referred to above.
It is compulsory and necessary for a person to undergo training on the GCP guidelines before taking part in any clinical research operation. The Professional Certificate in Advanced Good Clinical Practices (GCP) course is designed to prepare clinical research personnel in accordance with the applicable GCP guidelines. This on-line training program is covered by 12 quality course modules to do so in-depth training on the ICH-GCP guidelines and related clinical research procedures.
Module 1: Introduction to Clinical Research
Module 2: Evolution of ICH-GCP
Module 3: GCP Guidelines and Code of Federal Regulations (CFR)
Module 4: Roles and Responsibilities
Module 5: Institutional Review Board (IRB)
Module 6: Informed Consent
Module 7: Study Subject Recruitment and Retention
Module 8: Safety Reporting and Adverse Event Management
Module 9: Monitoring and Quality Assurance
Module 10: Research Protocol
Module 11: Essential Research Documents
Module 12: Research Misconduct
Clinical Trials Terminology
Assessment through Online Exam
You can also view our FAQs page for further queries.
Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All
one of the best institute in guntur city for science students.Satisfied with teaching.Placements available all over india including MNC's
Thanku Pharma Research I would like to recommend Pharma research to anyone who wants to make career with advance clinical research programme and management. Co - operative & experienced trainer. Hands-on practice provided from the first day. Course instructor will help you in each and every small things. I have got a many reference calls for job from the institute itself. And I placed in MNC now. Thanks to Pharma Research
I had a wonderful time with PHARMA RESEARCH. Pharma research is one of the 1st and best clinical research institute in Andhra Pradesh. The study materials are extensive designed. The support team gets regular feedback and managed to resolve any technical issues. The assignments are very well designed. It is definitely worth the money and time spent. I especially wanted to thank the faculties and support team for the follow ups and quick replies to my queries. I had a very positive experience with pharma research. On the whole, it's definitely worth the money, effort and time spent. I would truthfully suggest pharma research to anyone interested in expanding their skills.
Pharma research is a first clinical research institute in andhra pradesh. It was an amazing experience in PHARMA RESEARCH, GUNTUR. I would recommend to join if you have any interest in Clinical research, pharmacovigilance or CDM, well experienced staff, Thank you rehmat medam for your valuable support through out the period. Thank You PHARMA RESEARCH, GUNTUR. Well trained faculty and good knowledge sharing. Excellent placement service. International certified course material and globally recognized certificates. More over, you certificate 100% verified from pharma research website.
I never seen ever such a good organization with Live senario faculty I'm very proud to be a part in this organization... Thank you Pharma Research
PHARMA RESEARCH, one of the finest clinical research training institution in ANDHRA PRADESH. The method of teaching is awesome, comparing with other clinical research institution, they has good training faculties and good atmosphere and most important is FEE. its very affordable fee. I suggested to all b.pharma, m.pharma and all pharma student and science students should learn clinical research in PHARMA RESEARCH. PHARMA RESEARCH you are going good and all the best.