The value of quality clinical data management

What is clinical data management?

Clinical data management involves the collection and management of data during a clinical trial. During clinical trials, large volumes of data are collected. The role of the clinical data manager is to ensure that the data you collect:

• is applicable to your research question
• correctly captures the patient journey during the study

The clinical data manager develops and maintains the clinical database which is used to collect this information. They work closely with the study statistician and other project team members to ensure the accuracy and validity of data collected.

What else does the clinical data manager do?

Database development and maintenance is only one aspect of clinical data management. There are several other critical processes that ensure quality outcomes from your clinical trial. 

A good clinical data manager will work with your team to ensure all aspects of data management have been considered and documented. This includes:

• creating a data management plan
• selecting the most appropriate data management platform for your study, considering both functionality and cost
• working with your clinical team to ensure consistent site interpretation of the data
• working with your statistician to ensure that the data can be aggregated and analysed
• working with the medical writing team and clinical team to ensure all necessary data is being captured that is required for publication of the study

What is good database design?

Good database design supports the key data quality dimensions of:

• accuracy
• completeness
• consistency
• integrity

A good database also helps to promote positive study team to site relationships. Good clinical data management ensures data integrity throughout the lifecycle of your clinical research project.

Quality database design:

• improves accuracy and timely capture of relevant clinical data
• reduces manual review, promoting data consistency and integrity
• generates a quality analysis output and report

Why is performing clinical data review important?

During study enrolment, a clinical data review ensures:

• relevant data capture through standardisation
• consistent data capture across all participants and sites
• documentation of the clinical journey of each participant
• data issue resolution prior to analysis
• identification of data trends

But what if the data is not logical or consistent?

Inaccuracies in your data have the potential to lead to flawed analysis and misinterpretation of your results. A good clinical data manager will highlight study design challenges and data limitations, from study design through to final report.

What happens when data capture for your study is complete?

After data capture is complete, the clinical data manager will ensure clean data before locking the database and transferring it to your statistician. 

The clinical data manager works collaboratively with your statistician to ensure the analysis and interpretation is aligned with the data collected. This ensures higher quality in the analysis and reporting.

How can WSM assist you?

Our team of experienced clinical data managers can either provide both full-service capability to support your clinical development program or tailored task-based solutions, seamlessly integrating with your team whilst providing specific data expertise. Contact us for more details.