Clinical Data Manager (CDM): The CDM manages the data collected during a clinical trial. This includes planning, designing, and implementing the data management plan, creating case report forms, and overseeing the data entry, cleaning, validation, and reporting processes.

Study Monitor: The study monitor ensures that the study is conducted following the protocol and Good Clinical Practice (GCP) guidelines. This includes monitoring the data collection process, identifying and resolving errors and inconsistencies, and ensuring that the data is entered into the database promptly.

Biostatistician: The  is responsible for designing and implementing the statistical analysis plan, analyzing the data, and interpreting the results.

Data Entry Clerk: The data entry clerk is responsible for entering the data into the database using specialized software tools. They are responsible for ensuring that the data is entered correctly and promptly.

Data Quality Assurance (DQA) Staff: The DQA staff is responsible for monitoring the data collection process and identifying errors and inconsistencies in the data. Additionally, it is their duty to make sure the information is promptly and accurately recorded into the database.

These roles work together to ensure that the data collected during a clinical trial is accurate, complete, and reliable and is available for analysis and reporting under the study protocol.

Clinical Data Management: Steps

The steps involved in Clinical Data Management (CDM) include the following:

Planning: Defining the data management plan and creating the case report forms.

Data entry: Entering the data into the database using software tools.

Data cleaning: Checking and correcting errors in the data.

Data validation: Ensuring the data meets the requirements of the study protocol.

Data analysis: Analyzing the data to produce the results of the study.

Data reporting: Preparing the final report of the study.

These steps are designed to ensure that the data collected during a clinical trial is accurate, complete, and reliable and is available for analysis and reporting in accordance with the study protocol. CDM is a continuous process that starts before the trial and continues even after the trial is finished.

Clinical Data Management: Software Tools

There are various software tools available for CDM, such as:

• Clinical Data Management System (CDMS)
• Electronic Data Capture (EDC)
• Clinical Trial Management System (CTMS)
• Electronic Patient Reported Outcomes (ePRO)
• Randomization and Trial Supply Management (RTSM)

These software tools & clinical trial data management system are designed to support various CDM activities such as data entry, data cleaning, data validation, data analysis, and data reporting and to facilitate the overall management of the data collected during a clinical trial.

Clinical Data Management Internship Modules:

Programme Modules

Module 1: Introduction of Clinical Data Management

• The Clinical Data Management Process
• Objectives of CDM
• Roles involved in CDM
• Introduction to CDM Tools/Softwares

Module 2: Basics of Clinical Trials (Its Stakeholders : Roles and Responsibilities)

• Investigator
• Sponsor
• Contract Research Organization (CRO)
• Clinical Research Coordinator (CRC)
• Clinical Research Associate (CRA)
• Institutional Ethics Committee/IRB

Module 3: Guidelines for Clinical Data Management

• Documentation Scenario for Data Collection and Management
• International studies and data privacy
• Electronic source data in Clinical Investigations
• Guidance for Industry- ISO, ICH, HL7, CDISC, CDASH

Module 4: Data Management Plan(DMP)

• Introduction to DMP
• Need of DMP in Clinical Research
• Framework for creating a DMP
• Purpose of DMP

Module 5: Review and Finalization of study documents

• Essential Documents before, during and after the trial_ICH GCP
• Protocol
• Informed Consent Documents
• Investigator’s Brochure
• Case Report Form
• Clinical Study Report

Module 6: Electronic Data Capture

• The Electronic Data Capture (EDC) system
• Verification of EDC setup and implementation
• User Acceptance Testing (UAT)

Module 7: Database designing (CRF and IXRS)

• Purpose of CRF/IXRS
• Regulatory requirements in designing the CRF
• Techniques for Designing CRF/IXRS
• Paper CRF vs. Electronic CRF

Module 8: Data Entry, Data collection & CRF Tracking

• Data entry systems
• Data entry methods
• Data Entry Guidelines
• Data Entry Errors
• Remote Data Entry and its benefits

Module 9: CRF Processing & Inventory from site

• CRF Development Process
• Component of CRF
• Data Entry Status
• Discrepancy Status
• Colour coded response fields

Module 10: Data Validation

• CDM requirement in GCP
• Data Validation Process during the conduct of a clinical trial
• Validation steps performed by stakeholders (Investigator, Sponsor, Monitor, CDM team)

Module 11: Discrepancy Management

• Tools for configuring discrepancy management
• Reasons of discrepancies
• Review status of discrepancies
• Configuring the access status for discrepancies

Module 12: Database locking and Unlocking

• Data management Procedure for database lock
• Database lock process
• Unlocking the database lock
• Soft lock/Data cleaning
• Hard lock

Module 13: QA/QC checks in CDM

• Quality Control as per GCP
• Quality Assurance as per GCP
• Audit
• The Quality assurance Group
• Source data Review
• Source data Verification

Module 14: Data storage and Archival

• What is data archiving
• The benefit of data archival
• Data archiving and data lifecycle management
• Archiving for regulatory compliance

Module 15: Tools for CDM

• CDMS- Clinical Data Management Systems
• EDC- Electronic Data Capture
• CTMS- Clinical Trial Management System
• ePRO- Electronic Patient Reported Outcomes
• RTSM- Randomization and Trial Supply Management

Module 16: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

• E-Consent (Audio visual consent)
• E-Patient Reported Outcomes (e-PRO)
• IWRS
• Telemedicine
• Patient e Diaries
• Remote Patient MonitoringIndustry Partnerships:

Conclusion

Clinical Data Management (CDM) is a  in the conduct of clinical trials. It is critical to the overall effectiveness of a clinical trial in ensuring that the data gathered is precise, thorough, and dependable. CDM is a complex process that involves multiple roles, including clinical data managers, study monitors, and statisticians, who work together to manage the various stages of the process. The steps involved in CDM include planning, data entry, data cleaning, validation, analysis, and reporting. Software tools such as Clinical Data Management System (CDMS), Clinical Trial Data Management System, Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Patient Reported Outcomes (ePRO) and Randomization and Trial Supply Management (RTSM) are used to support these activities. By understanding the different aspects of CDM, professionals in the field of clinical research can ensure that their data is of the highest quality, which is essential for making informed decisions about the safety and efficacy of new treatments.