Conducting clinical trials is a complex and time-consuming affair. It involves numerous and different procedures, requires the collection of data from thousands of participants and constant monitoring. Let’s learn about eCRF.
A primary step towards conducting any clinical trial is to collect medical data or any other relevant data from different patients participating in the trail. The patients can be different with reference to indication, demography and may have a variety of different symptoms.
Case Report Form (CRF)
A Case Report Form (CRF) contains data obtained during the patient’s participation in the clinical trial. Medical researchers rely on the Case Reporting Form (CRF) to collect data about the disease from different affected patients and analyze them.
CRFs can be a simple set of 1-5 questions or a detailed form with many pages. Traditionally CRFs are made of paper. Recently, researchers have adopted information technology (IT) and use electronic Case Report Form (eCRF).
Electronic Case Report Form (eCRF)
The electronic capture of patient data related to a clinical trial is facilitated by an electronic Case Report Form (eCRF). This method of information gathering replaces the paper-based systems previously used by clinical trial investigators to record and submit data related to the research and outcomes of a study.
The switch to paperless information gathering has improved and streamlined the clinical trial data collection process in many ways.
The success of a clinical trial depends on data received at the end of the trial. Data collection faces many challenges. For instance, often, a clinical trial spans across several locations with the monitoring and integration of data being done from a single central location.
At the same time, each trial normally comprises of hundreds of different pieces of data to be compiled and processed for statistical analysis.
By providing a single portal and database to input and analyze data, clinical trial investigators and managers have a single source to turn to for highly organized and standardized information that can be quickly analyzed, sorted, and exported for clinical trial’s progress. This automated generation and reporting are called an Electronic case report.
eCRF is greatly beneficial and has following benefits:
- Provides more timely, complete and accurate case data in near real time for public health action.
- Helps in earlier detection of cases, permitting earlier intervention and lowered transmission of disease.
- Great potential in improved detection of outbreaks to allow earlier investigation and, potentially, earlier identification of risk factors for the spread of disease; and
- Supports creation of a new infrastructure to support rapid reporting of newly recognized and emerging conditions.
- Eliminates the errors that could occur in manual data entry, reporting and maintenance.
Electronic Case Reporting (eCRF) will automate public health case reporting by automatically generating and transmitting case reports from Electronic Health Records (EHRs) to public health agencies for further investigation, rather than manually reporting.
The eCRF captures critical clinical, demographic, laboratory reports of patient data submitted to public health.
There are many IT service provider companies which are in link with public health agencies who develop the necessary software required to generate eCRF as per the requirements of the researchers for further study.
Here is a list of 21 widely used Electronic reporting and data capture tools in the market and the companies which develop them:
- Rave from Medidata
- Inform from Oracle
- Oracle RDC from Oracle
- nowEDC from Datatrial
- Datalabs EDC from Perceptive (Subsidiary of Parexel)
- Macro from Elsevier
- QDS EDC from QDS
- Data Trak EDC from Data Trak
- TrialMaster from Omnicomm
- Encapsia from Cmed
- IBM EDC from IBM
- Target Health EDC from Target Health
- Veeva Vault EDC from Veeva
- eCaseLink from DSG
- Medrio EDC from Medrio
- Captivate EDC from clinCapture
- REDCap EDC from REDCap Cloud
- Nukleus EDC from TCD eClinical
- Bioclinica EDC from Bioclinica
- Castor EDC from Castor
- iMedNet EDC from MedNet
As the industry transitions toward electronic reporting, health information management professionals play a key role in supporting requirements for eCR.
It comes as no surprise that the manual approach of individually faxing, emailing, and making phone calls to public health agencies is time-consuming, error-prone, and inefficient, which reduces an epidemiologist’s ability to investigate potential cases in a timely manner.