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Clinical data management is the process by which important data is collected, integrated, analyzed, and validated while researchers conduct clinical trials. Medical and pharmaceutical companies and organizations, as well as regulatory groups, push toward higher standards and quality assurance. This leads to a pronounced need for individuals and systems who provide CDM services.
What Is Clinical Data Management (CDM)?
IntroductionClinical data management training must prepare workers to conduct the services they provide with the utmost professionalism and attention to detail. A CDM expert processes many types of research data that come out of clinical trials pertaining to medical and treatment advancements. The job requires proficiency with various computer applications and database systems. Besides handling the digital technology surrounding the collected data, clinical data managers must also understand how to validate and clean the data so it is accurate and appropriate for the researchers' needs. The most important aspects of a clinical data management job entail:
- Ensuring accuracy of all clinical data
- Checking for complete data to facilitate accurate outcomes
- Making sure the collected data follows a logical path
- Maximizing consistency to weed out discrepancies and errors
What Role Does a Clinical Data Manager Play in Clinical Trials?The entire data management process involves various steps and responsibilities required for accurate clinical trial operations and completion. The primary activity involves delivering the most accurate data that supports the final results of the study. This end goal requires a multi-step process to ensure integrity, consistency, and validity of every piece of appropriate data. CDM professionals usually work as part of a team. The specialists collect and compile results from various medical or pharmaceutical studies. Bachelor's or even Master's degrees are required for the various stages of clinical data management careers, though a CDM course provides appropriate skill brush up and familiarization. Besides simply collecting and reviewing data, these management professionals must understand and follow all appropriate regulations in order to make sure the clinic or research facility does not experience any blocks or issues with official organizations like the FDA.
Top Companies Offering Jobs in Clinical Data ManagementA search through online job boards and approaching recruiters for the medical, clinical research, and pharmaceutical industries may result in quite a lot of clinical data management jobs for those who finished appropriate CDM courses. The following six organizations offer considerable opportunity for properly-educated and high-skilled professional data managers.
TCS – TATA Consultancy ServicesInstead of directly providing clinical data management teams, TCS specializes in the current transformation of data collection and analysis processes to more digitized methods. Still, all the hospital and clinical wearable devices or sensors cannot exist without the help of the human touch. They are primarily interested in CDM specialists with a focus on Business 4.0 understanding and capabilities.
NovartisThis international company focuses on improving and extending lives through appropriate clinical and other research trials in both medical and pharmaceutical specialties. In order for the data to inform improvements and innovation, professional CDM team members must collect and handle data in conjunction with new digital and AI systems.
IQVIAAs one of the global leaders in CDM, IQVIA offers opportunities to those who successfully completed appropriate clinical data management training. Their interests transcend managing numbers and bits of information. They look for experts who can handle all of it properly and add the all-important touch of human insight to a modern process of data management.
ParexelWith locations in Massachusetts and North Carolina, this data management company offers career opportunities for excellent CDM professionals from a diverse range of nations. They focus on both the heart and mind when it comes to delivering the best possible outcomes from every research study and trial they work with. This makes clinical data management that much more important.
AccentureA combination of managing collected data and their innovative Intent data collection digital device makes them one of the forerunners of the new data revolution in medicine and healthcare. Clinical data management specialists required working knowledge of how to collect, validate, and handle digitized research information.
Why the CDM Job Market is So PopularBoth the medical and pharmaceutical industries constantly conduct a variety of research studies to improve treatment plans and medications for people suffering from everything from epilepsy to cancer to heart disease and beyond. These studies will not provide solutions if the data collected from them fail to get used in an appropriate manner. This makes clinical data management training of the utmost importance for the advancement of healthcare and disease treatment around the world. The CDM job market is so popular because the world of research creates more data all the time, and someone has to ensure its accuracy, usability, organization, and compliance with all necessary regulations.
What Is the Difference Between CDM and SAS?CDM stands for clinical data management and involves collecting data from more than one research trial and integrating it with similar data collections in order to create a fuller and more accurate picture. SAS stands for statistical analysis software and it takes the clinical or research data, analyzes it digitally, and generates various reports or charts that the researcher or other organization can use to form decisions. In many instances, CDM and SAS go hand in hand in practical application. The management professionals that do the human side of data collection sometimes use SAS programs to then deliver the final, organized, and understandable report. When it comes to jobs in the industry, clinical data management hires people who perform the particular collection and cross-checking services, and SAS requires programmers who create the systems.
Clinical Data Management Jobs vs. Medical Coding JobsIn the medical field, every diagnosis, treatment options, medical procedure, piece of equipment, and provided service has a unique alphanumeric code. When a patient's records are created and finalized, a medical coder transforms any documentation or notes into this code. This job usually has something to do with filing for insurance payments. The highly trained professionals must maintain complete accuracy. Clinical data managers collect and process data instead of transforming it into universal medical codes. If they get the information from a research study or other clinical trial, gather it together with other trials' data, and validate it for accuracy and relevance, the medical coding specialist may then turn it into the letter and number codes that represent the processes used. Each career provides valuable services to the medical community and health-related industries. They both need considerable training to gain employment and succeed.
What Are Clinical Trials?Whenever a medical researcher, organization, or company wants to develop a new treatment or medication, they need to do a lot of lab-related research before they get to clinical trials that test them out on real people. The process of developing an appropriate clinical trial goes through a lot of steps and involves regulations from many sides. After all, a researcher cannot perform random experiments on people without certain safety assurances in place. The various reasons for clinical trials include:
- Testing of pharmaceuticals for help and safety
- New medication forms: pills, capsules, liquids, etc.
- Existing drugs that may have alternate uses
- Evaluating vitamins, minerals, herbs, and other supplements
- Tests to see if treatments or procedures can give a positive outcome
- Attempts to find new ways to track diseases
Clinical Trial Stages ExplainedEvery clinical trial must go through the following four phases. These ensure that everything is tested properly to get the best and safest possible outcome.
Phase IThe first round of pharmaceutical testing must include at least 10 people with adequate health. These Human Pharmacology Trials give researchers the first information about whether a particular mediation or treatment is safe, does not have excessive side effects, and if it demonstrates therapeutic change.
Phase IIThe Therapeutic Exploratory Trials increase the number of research subjects. This phase of a clinical trial is designed to test if a drug is effective and safe for the people it is intended to treat. Each medication gets tested against a placebo.
Phase IIIThis wide-spread research study usually includes thousands of study participants who test the drug for a longer period of time. This expands the research pool to various countries, age groups, ethnicities, and other demographic characteristics.
Phrase IVAt this point, the new medication has been approved for use. This Post Marketing Surveillance phase has more to do with figuring out how to sell the drug rather than if it works well or not. Each medication gets compared to similar drugs on the market. Of course, researchers keep looking for unexpected side effects.
What Is the CDM Process?The process involved in clinical data management follows the same basic steps no matter what type of research studies and data are involved. Of course, the modalities may change from one company or organization to the next. Study Document Review and Finalization The team identifies the data types, figures out what they will collect, and determines how best to format the data itself. This focuses on consistency and intuitive structure. Then, the CDM team creates a Data Management Plan (DMP) that clearly states the road map to move forward with the project.
Design the DatabasesCDMs do not type everything into a spreadsheet and call it a day. The databases they design are project-specific, partially automated, and involve both the DMP rules and outside regulations and requirements. They create databases to make the data collection and investigation process more organized and efficient.
User Acceptance Test (UAT) of DatabasesBefore data can be collected in a study, the clinical database has to be developed and tested by Clinical data manager.
Collect the DataWhat used to happen with paperwork now primarily occurs using digital methods. With either method, the data from various studies or sources gets combined into the system. This helps eliminate errors and locate discrepancies quickly.
CRF TrackingThe case report forms (CRF) for each project are under control of the CDM team for storage, retrieval, and tracking throughout the process. This ensures the safety of the data so nothing gets left out of the final valuation.
Data EntryFor paper-based Clinical trials, CRF data will be entered into the Clinical database by Clinical data entry person.
Validating the DataEach DMP has certain protocols in place to make sure all the data is valid and appropriate for the clinical data management project. If the team finds any discrepancies, the quality control investigators take over.
Discrepancy ManagementA Data Clarification Form (DCF) is created for any discrepancies and managed in the specific way appropriate for a particular project. This process is also named query resolution and is ongoing throughout the process.
Medical CodingAll records appropriate for the particular CDM project is transformed into regulated medical coding. This ensures proper understanding across the board and maintains consistency in data and any comments or additional reports.
Database LockingOnce the Clinical Data Management team ensures a clean and error-free clinical database, the team locks the database to prevent any further changes in the database. This process requires agreement by everyone involved with the CDM project.
CDM Team Roles and ResponsibilitiesEvery clinical data management project involves a team of individuals that work together to get the best and most accurate outcome possible. They need advanced education, proper training, medical knowledge, and IT or computer skills.
Different Clinical Data Management Roles
- Data manager
- Database design and programming expert
- Clinical data coder
- Clinical data coordinator
- Quality control associate
- Data entry personnel
Responsibilities of the CDM Project TeamBesides the complexities of collecting, validating, organizing, and otherwise using all the data from specific medical or clinical trials, the clinical data management team also interacts with study sponsors, sticks to deadlines, and handles all operational issues that may arise. The Clinical Data Management training course will help you prepare for this complex and important role.
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- Introduction to Oracle Clinical Database Unlimited
- Introduction to Clinical Research and Clinical Data Management Unlimited
- Different Phases of clinical trials Unlimited
- INDA, NDA Applications Unlimited
- ICH-GCP Guidelines Unlimited
- Responsibilities of Clinical Trial Team Unlimited
- Protocol and Informed Consent Forms Unlimited
- Clinical Data Management Process and Life cycle Unlimited
- Data Management Plan Unlimited
- Case Report Forms, Types of CRFs Unlimited
- Designing of CRFs Unlimited
- CRF Annotation Unlimited
- Data Capture Methods and EDC Unlimited
- Data Entry – First pass and Second Pass Entry Unlimited
- Edit Check Specifications Unlimited
- Data Validation Procedures Unlimited
- Discrepancy Management 00:00:00
- Data Clarification Forms (DCFs) 00:00:00
- Database Locking and Freezing Unlimited
- Data Coding and Medical Dictionaries Unlimited
- SAE Reconciliation Unlimited
- Introduction to OC window 00:00:00
- Subsystems in OC 00:00:00
- Defining Programs and Projects 00:00:00
- Defining Organization Units 00:00:00
- Defining Regions 00:00:00
- Defining Planned Studies 00:00:00
- Easy Study Design 00:00:00
- Creating Intervals 00:00:00
- Creating Events 00:00:00
- Creating Investigator, Site Records and Assignments 00:00:00
- Creating Patient Positions and Assignments 00:00:00
- Creating Questions 00:00:00
- Creating Question Groups 00:00:00
- Creating and Maintaining DVG’s 00:00:00
- Creating DCM’s, DCI’s & DCI Books 00:00:00
- Test a Study 00:00:00
- Test Data Entry 00:00:00
- Initial Login 00:00:00
- Key Changes 00:00:00
- First Pass Entry 00:00:00
- Second Pass Entry 00:00:00
- Comparison Reconciliation 00:00:00
- Update 00:00:00
- Browse 00:00:00
- Patient Enrollment 00:00:00
- Data Validation(Batch validation) 00:00:00
- Discrepancy Management Unlimited
- Data Clarification Forms (DCFs) 00:00:00
- Locking and Freezing 00:00:00
- Data entry in RDC 00:00:00
- Discrepancy Management in RDC 00:00:00
- CRFs in RDC 00:00:00