(Newswire.net — January 6, 2020) — Clinical data management is a crucial process in CRO clinical trials because the data collected during a clinical trial is analysed for safety and efficacy. This analysis forms at the basis for decision-making on product development in the pharmaceutical industry.
Three Stages of Clinical Data Management
There are generally three stages of clinical data management – Study Setup, Study Conduct and Study Closeout.
The Study Setup stage includes all the activities conducted before the start of the study. The study Conduct Stage starts once subject enrolment begins or with the first patient getting enrolled. The Study Closeout stage is when the data is final and ready for statistical analysis.
In terms of time and effort, the study setup takes about 15% of the time and effort followed by study conduct which takes about 60% of the time and effort followed by study closeout which takes about 25% of the time and effort.
The conduct and closeout stages of Clinical Data Management study overlap due to ongoing subject enrolment and corresponding case report form submission.
The study setup stage includes activities such as preparing a data management plan, preparing a report form, building an annotation database design, checking or validating rule implementation and user acceptance testing.
The study conduct stage activities include ensuring the data collected is validated and consistent, central laboratory or third-party data transfer data coding, query management, reconciliation, reports generation and tracking.
Study closeout activities include ensuring all data management activities are complete database is locked and electronically archived and transferred.
There could be more or fewer activities associated with each setup depending on the organization protocol or phase of the CRO clinical trial study.
Clinical Data Management Process
The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much data as possible per analysis for the regulatory submission.
CRO clinical trial data is collected in CRS case report forms that are transcribed into clinical data management systems for validation and analysis.
Data capture is of three types: paper data capture, electronic data capture and remote data capture.
In paper data capture, data is entered on a paper case report form. A data entry associate enters the data into the clinical database. The process involves entering or transferring data from case report form to clinical data management system CTMS such as Oracle or clinical inform.
The disadvantage of paper data capture is that it does not provide real-time access to the data and it is a slow process, taking up considerable time.
As the name suggests, in electronic data capture, data is captured in an electronic case report form. An investigator enters the CRF data directly into the database providing real-time access to the data.
In remote data capture, data is captured in electronic case report form and the system allows research staff or site staff to enter data directly into the system. This can be useful in case of multicentre studies where there can be patients from multiple sites where the study is conducted with many institutions participating.
Role of Clinical Data Managers
Once a sponsor finalises the CRO clinical trial protocol, the selection of an investigator is done through a sponsor approval process involving the Institutional Review Board (IRB) and regulatory authorities.
Once patient recruitment commences, data gets collected into the case report forms which are sent to data managers in case of paper studies.
In the case of electronic data capture, the CRF data is directly entered into the database. The clinical data manager performs data entry and validation. The next step in data analysis reporting is the extraction of data which results in meeting final report submission to the FDA.
Once patients start enrolling into the trial, the clinical trial investigator begins administering the treatment and collecting the patient data. The data collected is recorded on the CRS and the lab samples are sent to the laboratory for assessment.
In the case of paper studies, data clarification forms are nothing but the clarifications which the Data Manager requires from the site. In the case of electronic data capture, queries will be generated. The data collected is recorded in the CRF and lab samples are sent to the laboratory for assessment. Data recorded on the CRF by an investigator is verified by the site monitor.
The source documents, both data from the CRF and laboratory are then sent to Data Manager who runs validation checks on the data and performs data. As a result of data cleaning activities, data clarification forms are generated and are sent to the investigator for clarification.
The database is updated based upon the resolutions received and the clean data is sent for analysis. The data clinical study reports are created by a medical writer based on the statistical analysis results submitted to the regulatory agencies for approval.
CRO clinical trials often involve patients with specific health conditions who then benefit from receiving unavailable treatments. While initiating the clinical trial, investigators first identify the medication to be tested and then the sponsor decides what to compare the new medication to, and what kind of patients might benefit from the medication or device.
Integration of Clinical Data
Integration of clinical data is about ensuring that data incorporated into the CDMS, the clinical data management systems are correct, consistent and are an exact replica of the data received on the case support forms or paper forms.
The next step in clinical data management process involves validation of data which has been entered into the System. This is done through User Acceptance Testing (UAT). Validation of clinical data is done by a programmer using electronic programs.
Interdependent groups in clinical data management
In clinical data management, day-to-day activities begin with the final approval of protocol. All data management activities are performed closely with the programmer and biostats team. The programming team helps to program the validation and derivation checks which are required to identify the discrepancies in the database.
When these validation checks are executed, discrepancies are generated in the clinical data management system. Discrepancies will be actioned by the data managers who clean data is provided to the biostats team.
The biostats team perform data analysis and the results of data analysis are used for the generation of clinical study reports which will be submitted to the regulatory authorities.