"A Summary of EDC - Comparison of Paper versus EDC"

January 7, 2003

Dr. Kirk Mousley

Pharmaceutical and Biotechnology companies are required by the FDA to perform controlled clinical trials of potential drug compounds to prove the compounds are safe for human consumption and are effective for treating human diseases. An important piece of executing clinical trials is the collection of data that will hopefully prove drug compounds are safe and effective.

Traditionally, clinical trials data is collected on paper forms called Case Report Forms (CRFs). Investigator site personnel fill out these forms as the trial progresses for a given trial subject. Data entry personnel at the company running the trial (also called the sponsor) then transcribe the written data into electronic form in a clinical trials database.

In detail, the paper based collection process is made up of at minimum the following steps:

1. Delivery of study materials - CRFs, Investigator Brochure, and "Study Compound" to site.

2. The investigator will enroll a patient into the trial and get necessary enrollment or randomization information from the sponsor (e.g., the drug company).

3. The investigator will have a member of the site staff fill out the CRFs from the patient charts, lab records, and other pertinent medical records. Patient diaries are like wise filled in by the patient at this point in time.

4. The CRA goes to the site to review the CRF, add notes to the CRFs, and then bring them back to the sponsor, or sends them to the sponsor.

5. Once the sponsor receives the completed CRFs, the data is then entered into a clinical data entry system.

6. Once the data is in electronic form, a number of checks are run on the data to verify its correctness.

7. If data is found that the sponsor believes is incorrect, such as a therapy date being before the consent date, a form is sent to the investigator asking for clarification.

8. The investigator enters the correction for the data on the form.

9. Upon receiving a completed form from the investigator, the data coordinator corrects the data.

10. Steps 6 to 9 are repeated until all checks are passed to sponsor's or QA authority's satisfaction.

The traditional paper based data collection process is known for its inefficiencies. The two biggest time lags are the time needed to get the data to the sponsor, and the time needed to get corrections to the data to the sponsor.

Electronic Data Capture attempts to address these inefficiencies by moving the entry of data to the source of the data, and performing data verification at the entry site. Moving the data entry to the source of the data accelerates steps 3 through 5. Performing data verification at the site accelerates steps 6 through 9. However, the major impact is removing the loop implicit in step 10.

EDC can be implemented in a number of different ways. Perhaps the most promising way is to make use of the Internet. The sponsor company can deploy a browser-based data entry application. As long as the investigator site has Internet access and a web browser, investigator site personnel can use this application to enter the data for the clinical trial. The site user should be able to launch the data entry application, log into the application using his/her username and password, and enter the data. Data verification programs will flag errant data as it is being entered, allowing for data to be corrected on the spot.

There are other options to implementing EDC that are possible. EDC can also be implemented using Citrix Metaframe, a software application that allows remote users to be connected to a server over the Internet in a manner similar to a web browser. There are also hybrid systems that allow users to enter data locally on their own PC, and then synchronize the data on a periodic basis by connecting to the Internet and running the synchronization software.

No matter how EDC is implemented, the basic process changes remain the same. Entry moves to the investigator sites, and traditional paper based processes must be modified to accommodate this movement.

If you would like to be on our mailing list or to send me your comments, please email me at kirk@mousleyconsulting.com. 

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