Post Graduate Diploma in Clinical Research and Data Management
This course is run jointly by two premier institutions in the field of Clinical Research – Ruby Hall Clinic & PPCE, who impart quality education to students looking for a career within the industry.
Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug. The clinical trials conducted all over the world follow universally accepted guidelines and regulations. These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical studies and which have an approval from the required health and ethical authorities.
Designed to turn Life Sciences graduates into well-rounded, thinking individuals who will add value to the companies who hire them, the course includes a balance of theory, internship, and honing of soft skills that will increase your chances of employability.
We 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 more brighter.
MBBS, BDS, BAMS, BHMS, B.PHARM, B.Sc. (LIFE-SCIENCES, BIOTECH, NURSING)
NOTE: Candidates must provide self-attested copies of certificates of completion of their educational qualification to Ruby Hall at the time of registration.
Offered thrice a year. Six Months duration.
Rs. 50,000/- + GST – 18% (Total = Rs. 59,000/-)
This course is designed for maximum impact and consists of two parts:
Module1: Clinical Research Operations
Module 2: Clinical Data Management
The course shall be conducted on weekends for a period of SIX months,
Module 1 shall be conducted on Sundays at Ruby Hall Clinic and shall span 3 months, with one month internship.
Module 2 shall be conducted on Sundays at PPCE and shall span 3 months, including one month internship.
The course will include sessions on improving soft skills and interview techniques.
A candidate’s admission may be cancelled 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 refund of installments already paid and shall not be marked for performance or issued a certificate.
- Introduction to Clinical Research
- History and evolution in Clinical research
- Introduction to Pharmaceuticals
- Drug Discovery and Development
- II Practical Aspects in Clinical Research
- Clinical Research process flow
- Stakeholders in clinical research
- Essential documents
- Bioethics in clinical research
- III QA in Clinical Research
- SMV, Audit, Inspections and Quality Assurance in Clinical research
- IV Regulatory Affairs in Clinical Research
- Regulatory Authorities involved in Clinical Research
- Statutory Guidelines in Clinical Research
- Regulatory Submission
- V Career pathways in Clinical Research
- Overview to Data Management
- Protocol Review
- Data Management Plan
- CRF Designing
- Database Designing and User Acceptance Testing
- Edit Check Designing and Validation
- CRF Tracking and Data Entry Processes
- Data Validation & Query Writing
- Medical Coding
- Serious Adverse Event Reconciliation
- Laboratory Data Handling
- Database Closure
- Data Management Standards in Clinical Research – CDISC
- Overview to Electronic Data Capture
- Internship on Data Management Applications
- Activities/Assignments Duration: Ongoing
(Note: All the activities below are based on recruiter requirements and general interview patterns within industry)
- Designing CRF in Microsoft Word based on Protocol
- Identifying discrepancies on CRF pages
- Generating queries to the sites
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.
Ruby Hall-PPCE 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.