Certification Course Overview
Diploma certificate Program in Clinical Data Management (CDM) and Clinical Research
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. The course covers core topics essential for clinical research.
Course Duration: 6 Months
Mode: Online/Hybrid
Key Features
Certificate of program completion from the Rapture Biotech International Pvt. Ltd.
Exclusive hackathons and “ask-me-anything” sessions by Rapture Biotech.
Curriculum delivered in live online classes by experienced field veterans.
It helps you get noticed by top hiring companies.
What you'll learn
Syllabus
- Introduce the basics of clinical research and its relationship with data management.
- Overview of Clinical Research: Scope, stakeholders, and types of studies.
- Role of Data in Clinical Trials: Importance of accurate and compliant data.
- Basics of Clinical Data Management (CDM): Definition, scope, and life cycle.
- Regulatory Framework: ICH-GCP, CDISC standards, and global guidelines.
- Explore how data management integrates with the drug development process.
- Drug Development Process: Preclinical to post-marketing phases.
- Data Management in Drug Development: From protocol development to regulatory submission.
- Regulatory Submissions and Data Requirements: IND, NDA, ANDA, and safety reports.
- Learn to design studies with a focus on data collection and analysis.
- Clinical Trial Design: Randomized, blinded, observational, and interventional studies.
- Protocol Development: Defining study objectives, endpoints, and data collection plans.
- Data Points in Protocol: Identifying key parameters for collection and analysis.
- Case Report Forms (CRF): Designing CRFs aligned with the study protocol.
- Gain an understanding of CDMS tools and processes.
- Types of CDMS: Paper-based, electronic (eCRF), and hybrid systems.
- Electronic Data Capture (EDC): Tools (e.g., Medidata, Oracle Clinical, REDCap).
- Database Design and Validation: Building robust and compliant databases.
- Data Migration and Integration: Importing/exporting data between systems.
- Learn techniques to ensure high-quality clinical data.
- Data Collection Processes: On-site vs. remote data entry.
- Data Cleaning: Identifying and resolving discrepancies.
- Query Management: Raising, resolving, and tracking data issues.
- Quality Control (QC) and Quality Assurance (QA): Ensuring data integrity.
- Understand the role of statistical methods in clinical trials.
- Statistical Methods: Descriptive, inferential statistics, and hypothesis testing.
- Randomization and Blinding: Ensuring unbiased results.
- Data Analysis Tools: SAS, R, SPSS, or Python.
- Interpretation of Results: Relating statistical outputs to clinical endpoints.
- Learn ethical and regulatory aspects of data management.
- GCP Principles and Compliance: Ensuring subject safety and data integrity.
- Regulatory Guidelines for CDM: FDA 21 CFR Part 11, GDPR, and HIPAA.
- Audit Trails: Tracking data changes for compliance.
- Data Anonymization and Privacy: Protecting participant identities.
- Integrate safety data handling with pharmacovigilance processes.
- Adverse Event Reporting (AER): Collecting and managing safety data.
- Safety Signals: Identification and risk assessment.
- Risk-Benefit Analysis: Using data for regulatory decisions.
- Safety Databases: Argus, ArisGlobal, and similar tools.
- Learn to document and report clinical and data management activities.
- Trial Master File (TMF): Essential documents for oversight.
- Clinical Study Reports (CSR): Compiling and summarizing trial data.
- Data Listings, Tables, and Figures: Preparing for submission.
- Regulatory Submissions: eCTD and other submission formats.
- Stay updated on the latest developments in the field.
- Intelligence (AI) in Data Management: Predictive analytics and automation.
- Decentralized Trials and Data Collection: Remote monitoring and wearable devices.
- Real-World Evidence (RWE) Integration: Combining clinical trial and real-world data.
- Blockchain in CDM: Enhancing data security and traceability.
Companies Hiring
Trainer’s Profile & Program Advisors
Dr. Annie Jessica
Dr. Annie Jessica Toppo holds a Ph.D. in Biotechnology from Birla Institute of Technology, Mesra, Jharkhand, and brings over seven years of experience in research and industry. She specializes in biochemistry, bioinformatics, pre-clinical trials, plant biotechnology, and nanotechnology, with a strong focus on drug-based research and scientific publications. Dr. Annie has led interdisciplinary projects at organizations like Digianalix and ICAR-IIAB, focusing on bioinformatics, agriculture, and plant-based drug formulations. Currently, Dr. Annie serves as a Scientist at Rapture Biotech Bengaluru, where she is responsible for Designing and implementing advanced biotechnological research projects and modules. Leading pre-clinical studies and developing plant-based drug formulations. Conducting training programs and workshops in biotechnology and bioinformatics. Preparing technical reports, and scientific publications. Collaborating with cross-functional teams to ensure successful project outcomes.
Dr. Surbhi Goyal
Dr. Surbhi Goyal, a dedicated scientist at Rapture Biotech in Mohali, Punjab, holds a PhD in Applied Microbiology from Punjabi University, Patiala. Throughout her doctoral studies, she focused on developing an antibiofilm biosurfactant from food isolates, guided by Dr. Jagdish Singh. With nine international research publications, including articles, reviews, book chapters, and authored books, she demonstrates proficiency in scientific writing. With over 8 years of experience in biotechnology through research and supervising 15 Masters dissertations during her time as an assistant professor, she possesses expertise in core microbiology, bioanalytical techniques, biostatistics, process optimization, molecular biology, and data analysis. Dr. Goyal actively participates in both national and international conferences, seminars, and workshops, reflecting her commitment to staying abreast of advancements in her field.
Job Profiles
Clinical Data Manager
Biometrics Project Associate
Clinical Data Coordinator
Clinical Data Lead
Clinical Data Scientist Lead
Data Management Project Manager
Clinical Data Standards Consultant
Clinical System Developer
Clinical System Designer
Clinical System Lead
Who can apply for this course?
Persons pursuing or passed out of M.B.B.S, BDS, B.Sc., M.Sc., B.Tech, M.Tech, Ph.D. in Biotechnology, Bioinformatics, Microbiology & other relevant qualifications and Corporate employees in the respective areas are eligible.
Course Fees
Duration | Indian | International |
6 months | 50,000 | 1000 USD |
Note:
Customized trainings are also available.
Special discounts are offered.
EVALUATION & AWARD OF CERTIFICATE
- Select Distance Learning Program of your choice.
- Fill online application form & Pay fees.
- Confirmation of admission & enrolment number.
- Transfer of Course material via E-mail.
- Download & submit Assignment.
- Evaluation.
- Award of Certificate based on performance in Assignment.
HOW TO APPLY
Step 1 – Click on “Apply Online Form from the website.
Step 2 – Completely fill the application form and submit online.
Step 3 – Submit application fee using:
For Indian students:
- NEFT from anywhere in India or Pay Via Phone Pay (9910181655).
- Name of the Account: Rapture Biotech International Pvt. Ltd.
- Account Number: 2612431210
- IFSC Code: KKBK0005033
For International Students:
- Bank to Bank Transfer by Swift Mode.
- Bank Name: Kotak Mahindra Bank, Sec-18, Noida
- Name of the Account: Rapture Biotech International Pvt Ltd
- Account Number: 2612431210
- Swift Code: KKBKINBB
- IFSC Code: KKBK0005033
Important Links
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Clinical Data Manager
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