Learn More about Clinical Data Science, Understanding EHRs and Informatics using real world Clinical Data.
MODULES - 25
HRS OF LEARNING- 300+
MONTHS - 3
FAQs- 450+
MOCK INTERVIEW FAQs- 150+
The primary role of clinical data management is to produce and maintain high-quality data from data entry through analysis. Performed correctly, the result of clinical data management is a dataset that is accurate, secure, reliable, and ready for analysis at the end of a study.
Who this program is for: Life Science, Pharma or Medical Graduate, Clinical Research and IT Professionals
- To Understand study data that is collected, organized, and saved to meet compliance requirements, such as CFR21 Part 11, good manufacturing practices (GMP), and good clinical practice (GCP).
- Develop advanced knowledge of the roles and responsibilities of various functionaries in CDM department such as Clinical Data Manager, Data Management Assistant, Data Team Lead (DTL), Database Programmer/Designer, Medical Coder/Writer, Clinical Data Coordinator, Clinical Data Analyst, Biostatistician.
- Practice the process of Query writing
- Detailed training in EDC tool and medical writing
- Thorough knowledge of Protocol Review and CRF Review
- Competence in managing end to end process in Data Management Plan.
- Working experience in EDC tool and edit checks writing.
- Soft skills development for Interview success.
- History and Why Pharmacovigilance
- Drug Development process
- ICH -GCP guidelines – PV perspective
- Oracle Argus suite training
- Adverse Drug Reactions (ADRs)
- ICSR – Work flow states and timelines
- Serious Adverse events (SAEs) & SUSARs
- MedDRA
- Drug coding
- Labelling Assessment
- Causality Assessment
- Narrative writing
- Query generation
- Follow up assessment
- Report generation and submission
- AOSE – Analysis of Similar events
- Reporting timelines
- Regulations and regulatory Databases
- Structure of Drug Safety department and cross functional teams.
- SOPS and working guidance in PV
- Medical devices
- Target medical events
- Vendor management
- Audits and Inspection
- Product quality complaints
- FAQs – Interview process
- Recent Updates to Drug Safety
- Future trends in Drug Safety
- Duration : 12 weeks
- Live webinars – twice weekly – 60 min each.
- 50 Self Paced online LMS Modules.
- 500 Hours of learning material – videos/ppts/assignments.
- Updated as per ICH/FDA guidelines.
- Recommended books provided.
- Hands-on Argus Safety database operation.
- Certification upon successful completion.
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Safety lead
CLINICAL DATA MANAGEMENT PROGRAM
Clinical Data Management (CDM) is the handling of information that results from clinical trials. All aspects of processing study information are part of clinical data management. This includes developing and maintaining software systems, databases, processes, procedures, training, and protocols to support collecting, cleaning, and managing subject or trial data.
Clinical Data Management is one of the most important phases in life cycle of a clinical trial of any drug or medical device before submission to the regulatory authorities for approval.
Mission of this program is to achieve knowledge of how to obtain trial data, which is consistent, accurate, validated and archived at the end before submission.
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