Clinical Data Management

Clinical data management (CDM) is a critical component of the clinical research process, ensuring the accuracy, integrity, and confidentiality of data collected during clinical trials. The primary goal of CDM is to organize and manage the vast amounts of information generated in these trials to facilitate valid and reliable analysis. Here’s a concise overview of clinical data management:

Clinical Data Management (CDM) is the process of collecting, cleaning, and managing clinical trial data in a standardized and organized manner to ensure data quality, integrity, and regulatory compliance.

STUDY START-UP

CRF Design and study build

eCRF Specification

CRF Annotations, Master CRF, ALS generation

Screens, Edit Checks and Custom Functions build.

Dictionary setup (MedDRA, WHODD)

Local Lab setup

User Acceptance Testing (UAT)

Study Documentation

Data Management Plan

Data Review Plan

eCRF Completion Guidelines

Edit check specifications, Programming and Validation

External data load documentation (Data Transfer Agreement) and Setup

IxRS Integration Setup, Validation and go-live

STUDY CONDUCT

User Management

Data Review & Discrepancy Management

Standard & Customized Reports for Data review & Metrics

Periodic Quality Review and CAPA

Medical Coding

Periodic and Milestone Driven SAE Reconciliation

External Data Transfers and Reconciliation (Central Lab, PRO, Images Pharmacokinetics etc.)

Postproduction Change Control (Migrations)

Periodic / Defined Snapshot (Data cut) support for interim submissions or analysis

STUDY CLOSE OUT

Interim analysis / Primary Analysis Readiness

Final QC of Data Base and issues closure/agreement

Database Audit by QA

Database Lock and Documentation

Data Conversion to SDTM or sponsor standards

Study Closure / Sites Closure Documentation

Study Archival / URL Decommissioning Support