Diploma In Clinical Research + Syllabus

Give me syllabus of Diploma in Clinical Research course which offer at Acedemy of Clinical Excellence?

[Saksham]

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

what is procedure of admission and age criteria for part time diploma in clinical research analysis and about placement