This guest post is contributed by Kirk Mousley of Mousley Consulting. He welcomes your comments at his email: kirk ~at~ mousleyconsulting.com.
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 use and are effective for treating human health issues. An important piece of executing clinical trials is the collection of data that will hopefully prove drug compounds are both 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 drug company running the trial (called the study 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:
- Delivery of study materials - CRFs, Investigator Brochure, and "potential drug compound" to the site(s).
- The investigator(s) will enroll patients into the trial and get necessary enrollment or randomization information from the study sponsor.
- 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 likewise filled in by the patient at the designated time(s).
- The Clinical Research Assistant (Study Monitor and CRA) goes to the site to review the CRF, add notes to the CRFs, and then brings them back to the sponsor, or sends them to the sponsor.
- Once the sponsor receives the completed CRFs, the data is then entered into a clinical data entry system.
- Once the data are in electronic form, a number of checks are run on the data to verify its correctness.
- If data are found that the sponsor believes is incorrect, such as a drug administration date being before the consent date, a form is sent to the investigator asking for clarification.
- The investigator enters the correction for the data on the data clarification form (DCF).
- Upon receiving a completed form from the investigator, the data coordinator corrects the data.
- Steps 6 to 9 are repeated until all checks are passed to sponsor's or QA authority's satisfaction.
Electronic Data Capture attempts to address these inefficiencies by moving the entry of data to the source of the data, and performing data verification (data edit-checks) 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 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. Responsibility for data entry moves to the investigator sites, and traditional paper based processes must be modified to accommodate this movement.
Fundamentally and overall, the language translation and globalization requirements are the same for paper and EDC-based entry systems. CRFs can be translated to the native language of the investigator site(s) and likewise, EDC data consistency error messages (and/or DCFs) can also be translated to the site’s preferred language. The main difference is that EDC will require the translations to be presented in electronic format, either in the EDC screens, or in the error messages presented by the EDC application.
There could be a couple places where translated EDC entry systems might prove beneficial compared to paper-based CRF-based entry systems. One might expect that native speakers of any given language would do a better job of data entry in their preferred language compared to a non-native speaker who does not know and understand the words they are entering. Furthermore, EDC might ease the burden of any needed translation of entered data to the language of choice for the study sponsor (and/or regulatory submission agency) by spreading out the data-centric translation chores over the life of the study, as opposed to one or more times of intense efforts that would be required once the paper CRFs were collected and data entered.
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Categories: clinical research