PG Diploma in Clinical Trial Management(Part Time)

Course Curriculum

* 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