Clinical Data Management (CDM) is the process of putting together, handling, collecting and analysis of clinical data, which is done in accordance with regulatory requirements. The field of Clinical Data Management was established due to demands from the pharmaceutical industry and regulatory authorities as a way to ensure that quality-assurance standards have been met while collecting data during a clinical trial.
The process of CDM begins before the study protocol has even been finalized. A Data Management Plan (DMP) is developed as a guide that includes a detailed description of the clinical trial’s CDM processes.
Key Roles Involved in CDM
Data Manager: A person who oversees the entire CDM process. They ensure that the research staff collects, manages and prepares the data accurately and securely. They work with different types of clinical data including administrative data, Case Report Forms (CRFs), electronic health records, laboratory data, patent and disease registries and safety data. The Data Manager is also expected to apply quality control checks at each stage of data handling, resolve any inconsistent data and code adverse events correctly using Common Terminology Criteria for Adverse Effects (CTCAE).
Database Programmer/Designer: Somebody who creates the clinical trial database, designs data entry screens, enables data validation and performs edit checks using dummy/test data.
Clinical/Medical Coder: Responsible for transforming reports into universal medical alphanumeric codes, especially cases of serious adverse events and the medical history of participants.
Clinical Data Coordinator: In charge of managing and organising data that has been collected from various departments and clinical trial programs. They ensure that the database is updated with accurate information, identify any errors and maintain records of transactions.
Quality Control Associate: Checks the accuracy of the data entries and performs data audits.
Data Entry Associate: Responsible for collecting information about the participants, tracking the receipts on the Case Report Form (CRF) and entering the data into the database.
Research Nurse: A nurse who works with participants during clinical trials while recording and managing data. Provides accurate and complete source documentation while implementing a Quality Control (QC) plan.
Data Management Workflow
1 INTRODUCTION
2 THE ELECTRONIC DATA CAPTURE (EDC) SYSTEM AND THE UNDERLYING CLINICAL DATABASE
3 NETWORK DIRECTORIES
4 DATA VALIDATION PROCESS
4.1 UNIVARIATE ALERTS
4.2 MULTIVARIATE AND CROSS-MODULE ALERTS
5 VERIFICATION OF EDC SETUP AND IMPLEMENTATION
5.1 SYSTEM SPECIFICATIONS
5.2 USER ACCEPTANCE TESTING
6 DATA ENTRY AND DATA CLEANING
6.1 PRE-REQUISITES FOR SITE DATA ENTRY
6.2 GRANTING ACCESS TO THE PRODUCTION VERSION OF THE EDC
6.3 ENTERING DATA
6.4 DATA SECURITY
6.5 QUALITY CONTROL PROCEDURES
6.6 QUERY GENERATION
7 LOADING ELECTRONIC FILES
7.1 LABORATORY NORMAL RANGES
8 MEDICAL CODING
8.1 ADVERSE EVENT/MEDICAL HISTORY CODING
8.2 MEDICATION CODING
9 EDC EXPORTED DATABASE
10 REPORTS
11 SAE RECONCILIATION
12 CHANGES TO A PRODUCTION EDC
13 DATABASE CLOSURE
13.1 CLOSURE CHECKS
13.2 QUALITY ASSURANCE AUDIT AND DATABASE LOCK
13.3 DATABASE UNLOCK
14 DATA ARCHIVING AND PROVISION OF FINAL MATERIALS TO SPONSOR
No comments:
Post a Comment