Online Training - Clinical Data Management in Oracle Clinical OC/RDC with Practical Hands on Training with Project Experience Certification & Placement Assistance
BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Clinical Data Management (CDM) Oracle Clinical Training in Hyderabad since the year of 2000. Online Clinical Data Management (CDM) Oracle Clinical Training in Hyderabad, India includes best Clinical Data Management (CDM) Oracle Clinical Training online Institute that imparts knowledge about the process of handling data from clinical research. Clinical Data Management (CDM) certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Clinical Data Management Training in USA, best Clinical Data Management Training in UK, best Clinical Data Management Training in Australia, best Clinical Data Management Training in Germany, best Clinical Data Management Training in Sweden, best Clinical Data Management Training in Netherlands, best Clinical Data Management Training in Singapore, best Clinical Data Management Training in Europe, best Clinical Data Management Training in Canada. Training in Online Clinical Data Management (CDM) Oracle Clinical is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. With the rising innovations and the rapid growth in healthcare sector, the demand for quality data pertaining to clinical research has been increased. Clinical Data Management, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry.
Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs.
Clinical Data Management Training
Clinical Data Management Training / CDM Training plays a vital role in Clinical Research, in capturing high-quality, reliable, and statistically sound data from clinical trials. Clinical data management helps collection, integration and availability of data at appropriate quality in compliance with US FDA/ICH guidelines.
If you're looking to boost your career prospects in Clinical Data Management, CDM Certificate Course is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, Clinical Data Management training is crucial. Compliance to European and American CDM regulations is important.
Brexit and implementation of the new regulatory base of Clinical Data in the UK, as well as in the Eurasian Economic Union (EAEU) countries, have transformed Data Management to a key element brought to the attention of all industry players. For years, a globally harmonized approach to Clinical Data has been discussed as a concept for integrated regulations. Considering the recent developments, we are Getting Closer Harmonized systems.
Clinical Data Management Training Online
Looking for professional clinical data management training? If you hold an associate's degree or higher and want to advance your career in Clinical Data Management or want to increase your skillset with the Oracle Clinical Database, our Online Training - Clinical Data Management in Oracle Clinical OC/RDC Database with Practical Hands on Training with Flexible Timings & Project Experience Certification with Placement Assistance is right for you to boost your career. Our CDM Certificate Course training online focuses on ICH-GCP/FDA (US)/EMEA (Europe, the Middle East and Africa)/Canada (Health Canada)/TGA (Australia)/MHRA (UK) guidelines, and hands-on oracle clinical database training. Unique program designed for professionals aspiring to make a career in Clinical Data Management using the in-demand, industry-based Oracle Clinical Database Software.
Online Training Features
- Web based classroom
- One faculty/student
- Placement support
- Regular/Fast track/Weekend individual slot
- Flexible timings
- Training Mode: Skype/Teamviewer
- Hands-On Training on the Database
- Direct access to Oracle Clinical Database
Certification
Course Certificate & Job Experience Certificate would be awarded at the end of the program.
Course Curriculum
- Clinical Development process
- Different phases of Clinical Trials
- SOPs, Protocol, Investigators Brochure
- Informed Consent process
- SAE reconciliation
- IRB/IEC
- ICH-GCP Guidelines
- Introduction to Clinical Data Management-Oracle Clinical
- Roles and Responsibilities of CDM Team
- Clinical Data Management Process and Life cycle
- Data Management Plan
- 21 CFR Part 11
- CRF Design
- Data Capture Methods
- Data Entry
- Edit Checks
- Data Validation Procedures
- Discrepancy Management
- Data Clarification Forms (DCFs)
- Database Locking and Freezing
- Data Storage & Archival
- Data Coding and Medical Dictionaries
- SAE Reconciliation
- CRF Annotation
- CDISC Standards
Practical Hands-on Training on Oracle Clinical Database
INTRODUCTION
- Introduction to Oracle Clinical window
- Subsystems in Oracle Clinical
STUDY PLAN
- Defining Programs and Projects
- Defining Organization Units
- Defining Regions
- Defining Planned Studies
STUDY DESIGN
- Easy Study Design
- Creating Intervals
- Creating Events
- Creating treatment patterns
- Creating Investigator, Site Records and Assignments
- Creating Patient Positions and Assignment
GLIB
- Creating Questions
- Creating Question Groups
- Creating and Maintaining DVG's
- Copy Groups
STUDY DEFINITION
- Creating DCM's, DCI's & DCI Books
- Validation Procedures
- Derivation Procedures
- Test a Study
- Test Data Entry
DATA ENTRY
- Initial Login
- Key Changes
- First Pass Entry
- Second Pass Entry
- Comparison Reconciliation
- Update
- Browse
- Patient Enrollment
- Missing DCMs
STUDY CONDUCT
- Executing Validation procedure
- Batch validation
- Discrepancy Management
- Data Clarification Forms (DCFs)
- Data Extract and SAS Extract
- Locking and Freezing
LAB
- Labs
- Lab Ranges
- Lab Units
- Lab test questions
- Lab Assignment Criteria
RDC (Remote Data Capture)
- Data entry in RDC
- Discrepancy Management in RDC
You will be extensively involved in
- Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
- Creation and maintenance of global library objects like DVGs Questions, Question groups, DCMs and DCIs
- Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
- Generating and Testing data entry screens and validate the range, format, date, missing fields
- Conduct study start up activities, like Study design and Defining Sites, investigators and patients
- Creating, generating and testing Data Validation and Derivation procedures
- Writing edit checks or validation procedures using ranges provided or in accordance with the protocol
- Performing User Acceptance Testing (UAT)
- Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison Reconciliation and Update
- Test and execute validation procedures (Both single and batch validation)
- Discrepancy management and Query management
- Generating queries based on validation checks to clarify and improve the quality of the data
- Creating DCFs and maintaining Discrepancies
- Resolving queries and updating the database.
- Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate.
- Improving the quality of the data to ensure an error free, accurate data with no open queries
- Establishing and coordinating the timely completion of the database lock procedures.
- Reviewing clinical data as per SOP, protocol, and study specific guidelines
- Knowledge of Data Extract and SAS extract views
- Maintaining Lab ranges, Lab units, Lab test questions
- Data entry in RDC and Discrepancy Management in RDC
Professional International organizations for clinical data management
- International Network of Clinical Data Management Associations (INCDMA) aims at the promotion of collaboration among clinical data management groups around the world. It is an international forum for discussion of and feedback on current topics of relevance to the discipline of CDM. It is composed of members the boards of the SCDM, ACDM (UK), DMB (France), PSDM (The Netherlands) who participate in the INCDMA proceedings and funding. It also regroups DM leaders and subject matter experts from Europe, North America, Israel, Japan, China and Australia.
- The Association for Clinical Data Management (ACDM) is a global organization founded in 1987 to support professionals in the management of clinical data.
- The Society for Clinical Data Management (SCDM) is an international organization promoting quality and excellence in data management.
- The Association Francaise de Data Management Biomedicale (DMB) is a French data management organization created in 1995. Gathers data from data managers (anyone involved in data management activity for developing drugs) from the pharmaceutical industry, CROs, software vendors or universities.
- The French network of data managers in academic biomedical research (AcaDM) is a network founded in 2008 which aims to offer a space for reflection between experts in order to standardize and improve practices.
Global Clinical Data Management Regulations
- Australia - Therapeutic Goods Administration (TGA)
- New Zealand - MEDSAFE
- North America
- Canada - Health Canada
- USA - FDA: Food and Drug Administration
- Central/South America
- Argentina - ANMAT
- Brazil - Agencia Nacional de Vigilancia Sanitaria (ANVISA)
- Chile - Instituto de Salud Publico (ISP)
- Columbia - Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
- Costa Rica - Ministerio de Salud
- Cuba - CECMED
- Dominican Republic - Direccion General de Drogas y Farmacias
- Jamaica - Ministry of Health
- Mexico - Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
- Paraguay - Ministro de Salud Publica y Bienestar Social
- Peru - Ministerio de Salud
- Uruguay - Ministerio de Salud Publica
- European Union - EMA: European Medicines Agency
- Armenia - Scientific Centre of Drug and Medical Technology Expertise
- Austria - Agency for Health and Food Safety (AGES)
- Belgium - Federal Agency for Medicines and Health Products
- Bulgaria - Bulgarian Drug Agency
- Croatia - Agency for Medicinal Products and Medical Devices of Croatia
- Cyprus - Ministry of Health
- Czech Republic - State Institute for Drug Control
- Denmark - Danish Medicines Agency
- Estonia - State Agency of Medicines
- Finland - Finish Medicines Agency
- France - Agence Nationale de Securite du Medicament et des Produits de Sante
- Germany - Federal Institute for Drugs and Medical Devices
- Georgia - Regulation Agency for Medical and Pharmaceutical Activities
- Greece - National Organisation for Medicines
- Hungary - National Institute of Pharmacy
- Iceland - Icelandic Medicines Agency
- Ireland - Irish Medicines Board
- Italy - National Institute of Health
- Lithuania - State Medicines Control Agency
- Luxembourg - Ministry of Health
- Malta - Maltese Medicines Authority
- Moldova - Medicines Agency
- Netherlands - Medicines Evaluation Board
- Norway - Norwegian Medicines Agency
- Poland - The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Portugal - National Authority of Medicines and Health Products
- Romania - National Medicines Agency
- Russia - Ministry of Health of the Russian Federation
- Serbia - Medicines and Medical Devices Agency of Serbia
- Slovakia - State Institute for Drug Control
- Slovenia - Ministry of Health
- Spain - Spanish Medicines Agency
- Sweden - Medical Products Agency
- Switzerland - Swiss Agency for Therapeutic Products
- Ukraine - Ministry of Health
- United Kingdom - Medicines and Healthcare Regulatory Agency (MHRA)
- Bahrain - I-SEHA
- Egypt - Ministry of Health
- Iran - Ministry of Health
- Israel - Ministry of Health
- Jordan - Jordan Food and Drug Administration
- Lebanon - Ministry of Public Health
- Saudi Arabia - Saudi Food and Drug Authority
- United Arab Emirates - Ministry of Health
- Bangladesh - Directorate General of Drug Administration (DGDA)
- Bhutan - Drug Regulatory Authority
- China - CFDA/NMPA: State Food and Drug Administration
- India - Central Drug Standards Control Organization (CDSCO)
- Indonesia - POM (Pengawas Obat dan Makanan)
- JAPAN - PMDA: Ministry of Health, Labour and Welfare
- Korea (South) - Korean Food and Drug Administration (KFDA)
- Laos - Food and Drug Department
- Malaysia - Ministry of Health (MOH)
- Nepal - Department of Drug Administration
- Philippines - Department of Health (DOH)
- Singapore - Health Sciences Authority (HSA)
- Sri Lanka - Ministry of Health (MOH)
- Taiwan (Republic of China) - Taiwan Food and Drug Administration (TFDA)
- Thailand - Food and Drug Administration of Thailand
- Vietnam - Drug Administration of Vietnam
- Algeria - Ministry of Health and Population
- Botswana - Ministry of Health (MOH)
- Burkina Faso - Le Ministere de la Sante
- Ghana - Food and Drugs Authority
- Kenya - Pharmacy and Poisons Board
- Morocco - Ministry of Health
- Nigeria - National Agency for Food and Drug Administration and Control
- Rwanda - Ministry of Health
- Senegal - Ministere de la Sante et de l'Action Sociale
- South Africa - Medicines Control Council (MCC)
- Swaziland - Ministry of Health
- Tanzania - Tanzania Food and Drug Authority (TFDA)
- Uganda - National Drug Authority