SCRI - The Program
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- SCRI - The Program
About the course
The course is aimed at graduates who aim to be part of the clinical Industry. The course is designed by the industry experts keeping in mind latest development and multi-fold requirements of clinical Research Industry. The course intends to provide a holistic view of the Clinical Research industry and provide insights into each element which contribute the clinical research requirements. In addition to the specifics of clinical research, the course would also prepare candidates for a career in corporate setting with focus on communication and other skills.
The course will cover all the elements of clinical research and will be blend of classroom courses ( 4 hours a day , 5 days a week for 4months) and 1 month of the job training with exposure.
Course Details:
- Course Name: Post Graduate Diploma in Clinical Research
Course highlights
- Course designed by industry experts
- 100% industry trainers
- Daily case studies presentation and discussion
- Includes training on soft skills development
- Course Fees – 75000
Eligibility:
- Eligibility: Freshers / Experienced candidates can apply
- B Pharm/M pharm
- B.Sc, M.Sc, ( Botany, Microbiology, Zoology, Chemistry, Biochemistry, Life sciences, Biotechnology, and Bioinformatics or similar lifesciences graduates)
- MBBS, BDS, BAMS, BHMS
Module Details
- Introduction to drug discovery and development
- Clinical trial terminologies
- History of clinical research
- Pre-clinical trials
- Definition of clinical trial
- Phases of clinical trials
- Introduction to pharmacology
- Routes of drug administration
- Pharmacodynamics and pharmacokinetics
- Bio-availability and bio-equivalence
- History of clinical research guidelines
- International Conference on Harmonization (ICH)
- Guidelines for Good Clinical Practice
- ICMR Guidelines for human subjects research
- Drug and cosmetic act
- NDCT Rules 2019
- Ethics committee role and responsibilities
- Informed consent documents
- Clinical trial protocol designing and writing
- Informed consent preparation
- Investigator’s Brochure (IB)
- Writing clinical trial report
- Project management – basics
- Project financing
- Conducting clinical trial feasibility
- Selection of an investigator and site
- Clinical trial stakeholders
- Ethics committee and regulatory submissions
- Investigator responsibilities
- Sponsor and monitor’s responsibilities
- Recruitment techniques
- Retention of clinical trial subjects
- Essential documents
- Investigational product – labelling and packaging
- Documentation in clinical trial conduct
- Safety and adverse event reporting
- Project auditing and preparation
- Introduction to CDM and statistics
- CRF designing
- Clinical data entry
- Electronic data capture
- Data validation
- Clinical data coding
- SAE reconciliation
- External data validation and reconciliation
- Data and tests for data analysis
- Maintaining quality in clinical research
- Handling audits and inspections
- Clinical trial management system
- Electronic Trial Master File (eTMF)
- Communication and soft skills
- Presentation skills
- Developing curriculum vitae
- Attending interviews
- Corporate compliance
- 16 weeks (4 months) of off-line classroom training
- 4 weeks (1 month) of on-job training
Selection criteria
- The Selection would be based on an online general aptitude test (MCQ’s)and subjective questions followed by Personal interview. Entrance exams dates will be shared with the candidates. Students have to enrol for the entrance exams on Apply now page
- The entrance exam shall be conducted online and shall by remotely proctored
- Shortlisted candidates will be called for personal round of interview (Personal only, in exceptional cases Virtual)
- Candidates will be selected based on their Merit Rankings
- Selected candidates will be sent joining letters
- This course is completely in offline and Virtual (Online) mode
Important Dates
- Announcement of Examination dates / Pattern: 15th August 2022
- Conduction of online exam: 18th September 2022
- Announcement of results and call letters for interview: 19th September 2022
- Interview: Virtually or Face to face – 20 th to 23 rd of September 2022
- Deadline for fees: 27th to 30th September
- Course Start date: induction: 3rd October 2022
- Start of classes: 10th October 2022
- SIRO reserves the right to change the dates and is subject to COVID restrictions
Placement Assistance
- 100% Placement Assistance provided in CROs and Pharmaceutical companies
- Interview preparatory sessions
- Resume Building
- Mock Interviews
- Please note the course does not guarantee a job in either Siro or any other Group Company or any other organization. SCRI shall make all efforts in preparing the candidates for interviews and would be getting in touch with various Companies For campus interviews and placement.
