Executive Diploma in Clinical Data Management (CDM)
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.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year Clinical Data Management program. The applicant must be a graduate in any discipline.
The course will be completed over a period of Three Months which will include the tenure applicable for examinations as well as case studies completion.
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.
- Assignments for all the programme modules for continuous evaluation and guidance.
- Interactive or recorded lectures on all key areas of the programme giving all flexibility to the participants.
- Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
- At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
- All learning and training delivery initiatives shall be conducted in English.
The registration dates for this programme run by the institute are updated timely on the webpage. The Training sessions and webinars are strictly scheduled depending on the availability of speakers. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
A one-time fees (lump sum paid at beginning of the course) for distance cum e- learning mode is Rs. 21,000/-(700 USD for overseas students) and Rs 50,000 /- for the part time (classroom) mode. This covers for the course registration fees, tuition fees, course material fees ect. Apart from this, an examination fee of Rs 400/- (USD 20) per module needs to be paid later as per the examination notification of the Institute.10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex-servicemen or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).
Examination & Certification
IGMPI follows a credit system based on all 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 timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Clinical Data Management by Institute of Good Manufacturing Practices India (IGMPI). For all the above mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
Placement Assistance & Corporate Relations
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, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Parexel, Quintiles, Biocon etc.
Future career prospects Clinical Data Management Programmes
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.
How to apply
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