| 5th November 2018 02:19 PM | |
| Unregistered | what is procedure of admission and age criteria for part time diploma in clinical research analysis and about placement |
| 11th February 2013 12:25 PM | |
| Saksham | Re: Diploma In Clinical Research + Syllabus Following is Academy of Clinical Excellence Diploma in Clinical Research course syllabus: INTRODUCTION TO CLINICAL RESEARCH Definition, Types and Scope of Clinical Research, Good Clinical Practices Drug Development Process Careers in Clinical Research ETHICS IN CLINICAL RESEARCH Integrity & Misconduct in Clinical Research Ethical Theories and Foundations, Ethics Review Committee and Informed Consent Process, Conflicts of Interest REGULATIONS IN CLINICAL RESEARCH Evolution and History of Regulations in Clinical Research, Patents US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections EURegulatory Affairs, EMEA Organization and Function, INDIAN Regulatory system, Schedule Y- Rules and Regulations CLINICAL RESEARCH METHODOLOGY Designing of Protocol, CRF, e-CRF, IB, ICF, SOP Pharmaco-epidemiology, BA/BE Studies Report writing, Publication CLINICAL RESEARCH MANAGEMENT Preparation of a successful clinical study, Study management, Project management Documentation, Monitoring, Audits and Inspections Pharmacovigilance Training in clinical research Budgeting in clinical research, Supplies and vendor management BIOSTATISTICS AND DATA MANAGEMENT Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management, Data validation, SAE reconciliation, query management Software considerations |
| 9th February 2013 12:04 PM | |
| lakshmi prann | Diploma In Clinical Research + Syllabus Give me syllabus of Diploma in Clinical Research course which offer at Acedemy of Clinical Excellence? |
