EDC is the computerized system designed for the collection of clinical data in electronic format. It is often cited as having its origins in another class of software -- Remote Data Entry (RDE) that surfaced in the life sciences market in the late 1980s and early 1990s. Sometimes referred to as Remote Data Capture (RDC). Clinical Data Interchange Standard Consortium (CDISC) has defined EDC in this way: "Collecting or acquiring data as a permanent electronic record with or without a human interface (e.g., using data collection systems or applications that are modem-based, web-based, optical mark/character recognition, or involve audio text, interactive voice response, graphical interfaces, clinical laboratory interfaces, or touch screens)."
The key issues resolved by the invention of this system are as follows:-
Type of data captured by the user.
Determining the user characteristics.
The data need to be gathered in a particular location.
The permanent network attachment has to be deployed.
The user needs to interact with the external devices.
Validation of input data is required.
Statistical analysis of the data which is collected.
The system has to confirm to externally imposed regulations.
The usage of internet has increased in the field of Data management due to the growing number of applications and enhancements of internet browser access. The Extension Markup Language (XML) offers potential for dramatic improvements. Even CDISC has provided many formats like, ODM (Operational Data Model) which is a common path to describe the systems. The data is submitted by the pharmaceutical company in the standard format to the Regulatory Authority.
The workflow of EDC is quiet simple, fast and accurate. The data is collected by the investigator in the eCRF by inquiring the patients. This eCRF is directly submitted into the database where the Data Manager extracts the data. CRA or Monitor review the data and perform audit trail on the system which much accurate method of trailing. The discrepancies or query generated are mentioned in the DCF (Data Clarification Form) sent back to the trial site for the correction by the investigator. When all the queries are resolved, the data are statistically analyzed but the statistician and interpreted to depict some result. After this the database is locked and saved safely.
The responsibilities of Regulatory Authority in data management:- ICH-GCP has laid down many guidelines for the proper functioning of EDC system.FDA also has several regulations for Electronic Data Capture which should be followed for proper execution of result. The section 21 Code of Federal Regulation Part 11, 1997 was drafted which governs the electronic records and signatures. This electronic signature is equivalent to hand written signatures. There should be a unique username and password linked to each and every individual. FDA guidance on computerized systems is considered to be the standard format in the clinical trials. Health Insurance Portability and Accountability Act, HIPAA, 1996 (this act determines the protection and confidentiality of data).
Some of the EDC tools are- Interactive Voice Response (IVR), Interactive Web Response (IWR), Pen Tablet, Personal Digital Assistant (PDA), Fax and Image Recognition Technology (OCR & OMR).
To overcome the limitations of Paper based systems, EDC system is popularized now-a-days. The problems associated with traditional paper based system are as follows:-
1. Time- it is very important to meet the deadline in this field. A little delay can lead to huge monetary loss to the sponsor. All the tasks like, data availability, patient recruitment, query resolution, completion of CRF, data review, database lock has to be completed in the given deadline.
2. Cost factor- the paper based work is costly as it requires documentation, printing, distribution, archiving the bulk of data and the charges of CRA travel are also included in this system.
3. Quality of data is poor as it is hand written. The data are less accurate, inconsistencies in validation of data, transcription of handwritten data.
4. Storage and archival of data is the biggest problem. It is quiet difficult to maintain the safety of voluminous paper CRF in the cupboards. The various environmental factors like, moisture, rust, dust, etc might destroy the complete data.
On the other hand, EDC has got many benefits and solutions of all the problems.
1. Time- the process is faster. Instant data availability, quicker query resolution, faster database lock.
2. Cost- this is less costly too. No documentation, printing, photocopying of data, less travel of CRA and reduced paper work.
3. Quality- data quality is enhanced. Protocols are updated online, transcription of handwritten data is not required and data validation is done online.
4. Storage and archival is more safe and easier. The database is locked by username and password. A large amount of data can be stored without any environmental effect.
EDC is highly beneficial and useful. But still it is not used by everyone. There are many companies which still rely on the traditional system. Reasons for delay in the adoption of EDC are- Regulatory concerns, Inertia or concern with changing current process, Cost or perceived cost, Lack of clear leader ECT/EDC application space, Insufficient implementation of common data standards, Resistance to Change, Expensive affair, not all trials are best suited to EDC, Lack of time for planning lead time for set up and training.
Perfection is the most imperfect thing in this world. Though, this system has some loopholes and demerits, it has still increased the comfort of many people. This web based technology has given standardised access. This fully integrated trial has Electronic Medical Records that would require significant harmonisation; Interactive Voice/Web based Response Systems, Clinical Trial Management Systems, Electronic Data Capture system for both the patient and investigator, External electronic data sources, SAE reporting/ pharmacovigilance systems which understand, prevent and scrutinise the adverse event related to the drug during the clinical trial, Electronic regulatory submission software in the standard format set by FDA and CDISC. This ensure us that EDC systems will be used more frequently in the future.
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