Clinical Research & Careers
"Advancing Healthcare Through Rigorous Exploration: Pioneering Clinical Research Initiatives at Rising Medicare"
CLINICAL RESEARCH SPACE
It is our desire that you enjoy this course, learn from it and gain experience from the internship programs which will give you a feel of working in a live setup. It is our aim that you will increase the pool of bright, enthusiastic and knowledgeable students who will enter the healthcare industry and make its future even brighter.
Careers
Exam Details
Twice in a 6 Months Course
1st Term after 3 months (Written Exam)
2nd Term after 6 Months (Presentation + Written Exam)
RISING MEDICARE HOSPITAL & RESEARCH CENTER
Syllabus for PG Diploma in Clinical Research Module
Module 1: Introduction to clinical research
Module 2: Pharmacology and drug development Module
Module 3: Ethics and Guidelines in Clinical Research
Module 4: Regulation in Clinical Research
Module 5: Clinical Trial Management
Module 6: Clinical Data Management & Biostatistics
Module 7: Career Pathways in Clinical Research
Course Modules
Module 1 – Clinical Research
- Introduction to Clinical Research
- Terminologies and definition in Clinical Research
- Origin and History of Clinical Research Clip Research and Clinical Practice
- Difference between Cl
- Types of Clinical Research
Module 2: Pharmacology and drug development
- Introduction to Pharmacology
- The concept of Essential Drugs
- Routes of Drug Administration
- Introduction to Drug Discovery and Development
- Hurdles in Drug Development
Module 3: Ethical Considerations and Guideline in Clinical Research
- Historical guidelines in Clinical Research Nuremberg code Declaration of Helsinki Belmont report
- International Conference on Harmonization (ICH) Brief history of ICH Structure of ICH ICH Harmonization Process
Guidelines for Good Clinical Practice Glossary:- The Principles of ICH GCP Institutional Review Board / Independent Ethics Committee Investigator Sponsor Clinical Trial Protocol and Protocol Amendment(S) Investigator’s Brochure Essential Documents for the conduct of a Clinical Trial
- Self Assessment Questions
Module 4: Regulation in Clinical Research
- Introduction of Clinical Trial Regulation
- European Medicine Agency
- Food and Drug Administration (US FDA)
- Drug and cosmetic act
- Schedule Y
Module 5: Clinical Trial Management
- Project Management
- Protocol in Clinical Research
- Informed Consent
- Case Report Form
- Investigator’s Brochure (IB)
Module 6: Clinical Data Management
- Introduction to CDM
- CRF Design
- Clinical Data Entry
- Electronic Data Capture
- Data Validation
Award and Certification
Certification is awarded to candidates only on successful completion of the course and after having paid all the dues with stipulated attendance.
Overall grades shall reflect on the final certificate as under:
Grade A – 85% and above
Grade B – 70-85%
Grade C – 50-70%
Grade D – Below 50% (Unsuccessful)
Only candidates who have duly filled in and signed the acknowledgement of the Code of Conduct in the Registration Form, and provided evidence that they meet the eligibility criteria shall be eligible to receive the final certificate. The management reserves the rights to change, delete, amend or modify its rules & regulations and schedules from time to time and this will be binding on all candidates currently enrolled in programs of an ongoing course. Rising Medicare reserves the right to make any updates to the programs through changes in title, methodology contents and structure.There may be changes in the schedule, postponement and cancellations of the sessions conducted in classes.
Cancellation of Admission
A candidate’s admission may be canceled if the candidate becomes a fee defaulter, or if it is found that evidence of compliance with eligibility criteria is false. In case of cancellation, a candidate is not eligible for a refund of installments already paid and shall not be marked for performance or issued a certificate.
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