The data is defined as any information or fact related to clinical trial. Management of data capture and data flow process is an important part of clinical data management. It is an integral, respected and highly valued member of clinical development team. Before starting the trial, the consideration is given to data management, including data privacy, data storage, record keeping, data protection, destroying the data and sharing and reporting the data.
Faster drug development process and in place quality systems to ensure to ensure generation of high-quality data for accurate drug evaluation are the benefits achieved from CDM.CDM professionals ensures standards for improving data quality.
This program is developed with the primary objectives of Introduction to the Clinical Data Management process, understanding of tools and management of clinical data.
The module based approach in Executive Diploma programme via distance cum e learning mode is designed for working professionals in full-time employment who wish to complete the course in shorter time duration. This course is beneficial for professionals from different streams to help them intensify their knowledge.
Module 1: Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders
Module 2: Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions
Module 3: Introduction to Data Management
Module 4: CRF Design Considerations
Module 5: Data Entry, Remote Data Entry
Module 6: Identifying and Managing Discrepancies
Module 7: Data Management Plan
Module 8: Electronic Data Capture
Module 9: Tracking CRF Data
Module 10: Managing Lab Data
Module 11: Collecting Adverse Event Data
Module 12: Creating Reports and Transferring Data
Module 13: Case Studies
After completion of this course, students will have clear understanding on various essential elements of clinical data management, theoretical knowledge on regulatory guidelines, CDM work flow, data management plan, different activities involving CRF designing, data entry, data collection, AE management, report creation etc. along with roles and responsibilities of CDM personnel.
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
The course will be completed over a period of Six months which will include the tenure applicable for examinations as well as case studies completion.
The registration dates for this bi-annual executive programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
All the participants are obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Clinical Data Management by Faculty of Clinical Research, IGMPI. For all the above mentioned modules elaborate course material and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical giants like Syneos Health, Novartis, Parexel, Medtronic, IQVIA, Genpact, Covance, Accenture, PPD, Alcon, Makrocare, Cytel, Pfizer, Panacea Biotec, Bioclinica, Teva Pharmaceuticals, Cliantha Research Ltd. etc.
Clinical Data Management (CDM) has long way with increased importance within and outside biopharmaceutical research and development. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. Major companies hiring clinical data management professionals are CTS, TCS, PPD, BMS, Pfizer, Accenture, ICON, Novartis, Quintiles, Parexel, Neeman Medical etc. This programme provides person, professional benefits such as sense of accomplishment, validation of CDM knowledge, recognition by company, ability to train others as well as assisting others and organizational benefits such as well trained and updated professionals, excellent professional development opportunities with increased efficiency and improved quality within the company. This course ensures a professional career in the clinical research industry as a Case Report Designer / Clinical Data Quality Assurance/ Quality Control/ Clinical Data Associate etc. in pharmaceutical/biotechnology sectors, CROs, etc.
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like