Clinical Trials - The Role Of Data Management
Clinical data management relates to the input, verification and quality control of data collected during a clinical trial. We are going to examine why it is so important and what sponsors can do to check the data management processes employed by the contract research organisation (CRO) they are outsourcing to.
A dedicated clinical data manager
The clinical trial data is so important to the development decision-making process that it's imperative to have a dedicated resource ensuring its quality and integrity. The CRO should have at least one dedicated member of staff acting as the clinical data manager. They will play a key part in the planning and performance of the trial.
Involved from inception, they will assess data collection options, methods and protocols. Once the trial actually begins, the data manager must ensure the collected data is consistent and complete. If the trial has many data sources (particularly across multiple sites), the data manager must ensure the data collection is standardized and that any transfer of data is secure. At the end of the trial, the data manager must ensure all planned data capture has been completed correctly and as expected. The data manager must then perform a database "lock" or "freeze" before passing on the data for statistical analysis.
A robust data management plan
The data management plan sets out exactly how the data collection will occur "" key elements include standard operating procedures (SOPs), a breakdown of data sources, the data management system or platform being used, data transfer protocols and quality control measures.
The importance of SOPs
SOPs ensure that all relevant legal guidelines and obligations are adhered to "" this is paramount to the success of a clinical trial.
A well-designed Case Report Form (CRF)
The CRF includes all the fields for data collection so must be very carefully designed to include all information required for statistical analysis.
A clinical data management system
The CDMS is a tool used to house and manage all of the trial data and can be in paper or electronic form. Electronic systems are preferable as they eliminate the waste of paper and they have built-in methods of verification. They can also alert you automatically to any unexpected data events.
It is imperative that a sponsor assesses a potential CRO partner on the above criteria and ensures that they have an excellent reputation for quality assured data delivery.
A dedicated clinical data manager
The clinical trial data is so important to the development decision-making process that it's imperative to have a dedicated resource ensuring its quality and integrity. The CRO should have at least one dedicated member of staff acting as the clinical data manager. They will play a key part in the planning and performance of the trial.
Involved from inception, they will assess data collection options, methods and protocols. Once the trial actually begins, the data manager must ensure the collected data is consistent and complete. If the trial has many data sources (particularly across multiple sites), the data manager must ensure the data collection is standardized and that any transfer of data is secure. At the end of the trial, the data manager must ensure all planned data capture has been completed correctly and as expected. The data manager must then perform a database "lock" or "freeze" before passing on the data for statistical analysis.
A robust data management plan
The data management plan sets out exactly how the data collection will occur "" key elements include standard operating procedures (SOPs), a breakdown of data sources, the data management system or platform being used, data transfer protocols and quality control measures.
The importance of SOPs
SOPs ensure that all relevant legal guidelines and obligations are adhered to "" this is paramount to the success of a clinical trial.
A well-designed Case Report Form (CRF)
The CRF includes all the fields for data collection so must be very carefully designed to include all information required for statistical analysis.
A clinical data management system
The CDMS is a tool used to house and manage all of the trial data and can be in paper or electronic form. Electronic systems are preferable as they eliminate the waste of paper and they have built-in methods of verification. They can also alert you automatically to any unexpected data events.
It is imperative that a sponsor assesses a potential CRO partner on the above criteria and ensures that they have an excellent reputation for quality assured data delivery.
