PG Diploma in Clinical Research and Clinical Data Management
Admission Procedure For Class Room Courses
PG Diploma in Clinical Research & Clinical Data Management Download Brochure
ICBio is collaborated with University of Mysore to offer globally recognized PG Diploma in Clinical Research and Clinical Data Management. We use high-quality and innovative approaches, methodologies and fulltime staff members, in research & teaching, to improve the job prospects for learners and aspirants of Life sciences thereby enabling them to meet the growing demand of skilled manpower for the Pharma, Healthcare, Life Sciences, and Biomedical industries.
The different wings of ICBio like CRO, BA BE , R & D Centre, fully equipped with state of art facilities, is involved in research projects in collaboration with its industry partners and our students are given practical training here by our experienced staffs who also holds faculty appointments. This fosters an environment of inquiry and discourse that stimulates innovation and enables the students to make the most of physical and intellectual resources.
As part of the Curriculum the students undergo 3 months of On Job Training/ Internship per Semester in a CRO/SMO or Pharmaceutical companies where they get experience in Designing protocols and Essential documents, Medical writing, Project Management, Regulatory Submission, Data Handling etc., there by enabling them to be at par with experienced candidates. We also conduct regular workshops, seminars and mock interviews and soft skill development programs thus preparing them to join the working environment.
Course Duration: 12months/ II Semester Regular Program
Certification: University of Mysore
Eligibility:
1. The candidates must have studied any Bachelor degree in Life science including Medicine, Pharmacy, Dental, BE in Biotechnology or any graduation in Allied Health Science/Life Science Graduates from a recognized University. B.Sc., in Nursing / B. Tech (BT) B.M.L.T / B.Sc., M.L.T
/ B.P.T /B.A.M S / B H.M.S
2. The candidates must have completed bachelor degree with an aggregate of 45% marks excluding languages(Relaxable to 40% for SC & ST candidates)
3. 50% marks of the entrance test and 50% marks of the bachelor degree examination excluding languages will be considered for preparing the merit list at the time of admission.
Course Curriculum
Credit based Choice Based continuous evaluation pattern System |
||||
| SEMESTER | HARDCORE | SOFTCORE | OPEN ELECTIVE | TOTAL |
| I | 16 | 04(08) | - | 20 |
| II | 12 | 04(08) | 04 | 20 |
| 28 | 08 | 04 | 40 | |
| Semester I | Semester II | ||
| Paper Code | Title | Paper code |
Title |
| 1.1 | Introduction to Clinical Research | 2.1 | Pharma Regulatory Affairs |
| 1.2 | Guidelines, Regulations and Ethics in Clinical Research | 2.2 | Clinical Trial Management |
| 1.3 | Site Management Organization | 2.3 | Good Manufacturing Practices |
| 1.4 | Perspective in Clinical Evaluation | 2.4 | Clinical Data Management |
| 1.5 | On Job Training | 2.5 | Dissertation work on ethics committee submission-Viva Voce |
| 1.6 | Minor project work Viva Voce |
2.6 | Project Work-Live project at CRO/Site Viva Voce |
Note: Each Semester will have 5 Courses, each Course of 4 credits,
Semester I & II are same for PGDCRCDM & M.Sc., in Clinical Research thereby enabling students to continue through lateral entry scheme.
Students' Presentations:
Each student will be given 3 presentations per semester
Group Project:
This innovative learning approach allows the students to apply the knowledge and skills gained during the taught course to prepare a substantial dossier of required documentation for a clinical research programme. The student will need to be able to do this as a member of a team, contributing to the overall project and taking responsibility for a particular area.
Individual Project:
A four month personal research project undertaken in industry or academia to allow each student to demonstrate their independent learning ability and interest in advancing their knowledge through the pursuit of independent research and/ or development work in an area related to clinical research. The research project is undertaken either in a pharmaceutical company, CRO, clinical research site, hospital or academic facility. During the research project you will be supported by your ICBio tutor to help you through the critical months establishing yourself as a clinical research professional.
