Clinical Trials

Clinical Data Management

Image Description
Samantha Trolli

Published 24 Nov 2022

Clinical Data Management - Infiuss Health

Share

Before getting into the details, let's first define what we mean by "clinical data management." Clinical data management encompasses a lot of different tasks related to managing all the information collected during a clinical trial—from collecting it to organizing it for analysis, creating reports for internal use or external publication purposes, etc.


Why do we need Clinical Data Management in Clinical Trials

Clinical data management (CDM) is an integral part of every study and requires a dedicated team with expertise in data governance, clinical operations, quality assurance, and regulatory compliance. A comprehensive CDM plan is developed prior to initiation of a trial to ensure that all risks are identified and mitigated prior to patient enrollment.

The quality of your collected data can make or break your project from beginning to end. That's why it's important for research teams—both academic and industrial—to invest time upfront into developing a robust clinical data management plan. A well-designed CDM program will ensure high quality clinical data by maintaining integrity across all aspects of study conduct throughout all phases from pre-study planning through postmarketing surveillance activities in order to demonstrate reproducibility and validity when required by regulators as well as contribute positively towards meeting statistical power requirements for analysis purposes.

What is Clinical Data Management

Clinical data management is the process of collecting, storing, and analyzing clinical trial data in a clinical trial. This process involves organizing, storing and analyzing clinical trial data.  All of these elements work together to ensure quality control and compliance with good clinical practices. The standard process for clinical data management is very well defined and relatively consistent across all sponsors, sites, investigators, and types of trials. Clinical research is a key part of medical science, as it allows doctors to learn more about different conditions or diseases and how best to treat them. Clinical trials are conducted at medical centers around the world by researchers who want to learn more about specific treatments or procedures. The results from these trials can help doctors make informed decisions on how they should approach treating their patients with certain conditions or diseases

Best Practice for Managing Clinical Data

Clinical data management may involve organizing and storing electronic health record data as well as entering patient information into a study’s database. In order for experimental treatments or procedures to be approved by regulatory authorities such as the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA), the integrity of their results must be established through clinical studies. These studies are generally divided into two categories: observational and interventional studies.[1] Observational studies include cohort studies, case-control studies, and cross-sectional surveys; interventional ones involve randomized controlled trials (RCTs).[2]

Clinical trials require careful planning before they begin so that all researchers involved have access to accurate information about participants' characteristics (e.g., age range), any preexisting conditions they may suffer from and historical medical records related only back to baseline measurements taken once before starting treatment.[3] This ensures that no one who might benefit from participating is excluded due solely on these criteria while ensuring minimum risk levels at all times throughout treatment.[4]

The proper management of clinical data is required to ensure high quality scientific research and the success of clinical trials.

The proper management of clinical data is required to ensure high quality scientific research and the success of clinical trials. Clinical data management is a critical component of clinical trials, but it’s often overlooked by researchers. The blueprint for data management in your trial should be created before you begin collecting any information from patients or other study participants.

When you submit a protocol to a regulatory authority such as the Food and Drug Administration (FDA) or European Medicines Agency (EMA), one of the most important documents that needs to be submitted with the protocol is your Clinical Data Management Plan (CDMP). This document defines how your study will handle all types of sensitive study-related information. Without this plan in place, you cannot begin collecting patient data in your study.

Conclusion

Clinical trials can be very complex, with many different types of data being collected from a number of different sources and locations. Therefore, it is crucial to have an effective system in place to ensure that all information is managed properly throughout the trial process. This ensures that researchers get accurate results from their patients as well as maintain compliance with local laws governing clinical trials. It also ensures that their findings are reproducible by other researchers who may wish to use this information for future studies or clinical applications.

Find new health insights

Infiuss Health insights contains inspiring thought leadership on health issues and the future of health data management and new research.