| A clinical trial is the application of the scientific method to human health. Since such trials require the use of human test subjects and can severely impact the well-being of the subjects, as well as treatments of other people and large amounts of capital for those performing the trial, the proper management of clinical trials is crucial.
Course Content:
• Drug Development Process, Clinical Trial terminology (New Drug Discovery)
• Various Stages in Clinical Drug development (Phase I to IV)
• Clinical Trial Budgeting
• Principles of good clinical practices
• Ethics in Clinical Research
• Roles and responsibilities of IRB/IEC
• Informed Consent Process
• Roles and responsibilities of:
I. Sponsor
ii. Investigator
iii. Research Coordinator
IV. Contract Research Organization
v. Clinical Data Manager
• Clinical Trial Documents
• Regulatory requirements in India, Japan, USA, Europe
• Quality Assurance and Patent Laws
• Audits & Inspection in Clinical Research
• Conducting BA/BE Studies
• Patient recruitment and retention in Clinical Trials
• Preparation of Protocol, CRF and trial related documents
• Clinical Trial Designing
• Management of Clinical Trials
• Biostatistics in Clinical Research
• Medical Writing |
