Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Includes resume support, narrative and mock.
Qtech-Learning Management System (Q-LMS)
Save on tuition and gain scholarship
Qtech-Sol is a Clinical Science Training Provider. This course provides Foundation learning to work as CDM Manager or Specialist. This is a job and title focused program. The course emphasizes about role of CDM towards clinical data capture, validating, auditing, and reporting tasks. The course curriculum is designed to give an edge to obtain job as CDM with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.
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. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
The Clinical Research Data Manager will develop and manage core area of clinical data obtained thru clinical trials or post marketing surveillance. A CDM person manages Clinical data and its quality, creates data management plan, performs validation and data entry, Clinical Research Data Management Systems (CDMS), Clinical data repository, loading of external data into CDM, Query management, data clarification form, database locking, patient diary, data cleaning and validation, and database archiving. The students will get practical exposure to real-time documentation and scenarios for Data Management Plan, Query Management, Coding of Adverse Events, SAE Reconciliation, Data Cleaning and Data Validation, Elements of CRF, e-CRF designing, Data tracking from CRF, and Types of Reports generated.
Recommended: An Associate or bachelor’s degree in Statistics, Biostatistics, Biotechnology, Economics, Computer Science, Engineering, Cognitive Science, Data Science, Machine Learning (ML), Artificial Intelligence (AI), Mathematics.
The Benefit Student Gains
The Benefit Student Gains
- Upgrading the Knowledge required.
- Better Resume Placement for promising jobs.
- Low Investment, high learnings
- Learn from Anywhere, Anytime at your pace.
- Job and Title Based Tasks as followed and Practiced in industry
- Applying Concept into Real-time (Policies, governance and tools)
- Work on Role Based Tasks followed and Practiced in industry
- Mocks and Narratives for Client Discussions
- Readiness to work with limited support
The program objective is to help Clinical Data Management to meet the following career pathways, after completing this practicum program. Students can apply for below open job titles based on highest education background and prior experiences (if any):
- Clinical Data Manager
- Clinical Research Data Analyst
- Clinical Data Associate
- Case Report Form Designer
- Data Quality Manager
- Clinical Business Analyst
The Clinical Research Data Management training program offered at Qtech provides insights into Clinical Research Data Management activities along with exposure to real-time documentation and scenarios pertaining to roles and responsibilities performed by Clinical Data Management specialist. Qtech provides in-depth into the core area of clinical data management like Clinical data and its quality, data management plan, data entry, Clinical Research Data Management Systems (CDMS), Clinical data repository, loading of external data into CDM, Query management, data clarification form, database locking, patient diary, data cleaning and validation, and database archiving. The students will get practical exposure to real-time documentation and scenarios for Data Management Plan, Query Management, Coding of Adverse Events, SAE Reconciliation, Data Cleaning and Data Validation, Elements of CRF, e-CRF designing, Data tracking from CRF, and Types of Reports generated.
|CLINICAL RESEARCH DATA MANAGEMENT|
|LIST OF TOPICS:
THEORETICAL ASPECT OF THE FIELD:
1. Introduction to Clinical Trials
2. Phase I Clinical Trials.
3. Phase II Clinical Trials.
4. Phase III Clinical Trials.
5. Phase IV Clinical Trials.
6. Good Clinical Practice And ICH Guidelines
7. SOP Development
8. Communication With Cross Functional Team
9. Introduction to Clinical protocol
10. Foundation of Clinical Data Management
11. Good Clinical Data Management Practices (GCDMP)
12. Data Management Plan
13. Clinical Trial Data and Its Quality
14. Clinical Data Management System
15. Clinical Data Repository
16. Loading the external data into the CDM system
17. Exporting Data to DMC
18. Clinical trial data cleaning and validation
|19. Query Management
20. Data Clarification Form
21. Patient Diaries & Patient Reported Outcome
22. Remote Data Entry
23. Clinical Data Entry – I, SAE Reconciliation – II
24. Elements of CRF
25. e-CRF Design & Data Tracking
26. Types of Reports Generated
27. Database Locking
28. Clinical Data Archiving
LIST OF EXERCISES:
CASE 1. Introduction to Clinical Trials
CASE 2. Protocol Design and Development
CASE 3. Data Management Plan
CASE 4. Data Cleaning and Data Validation.
CASE 5. Query Management.
CASE 6. Coding of Adverse Events.
CASE 7. SAE Reconciliation.
CASE 8. Elements of CRF.
CASE 9. e-CRF designing Data tracking from CRF
The program gave me an in-depth understanding of the role of a CDM in Clinical Research and Trial Management Teams. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!
The best part about CDM training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.
I am a Biomedical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Clinical Data Management training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled in an Internship program to meet my career goals.