Clinical research data management at UCT: understanding your options
7 Dec 2015 - 09:45
When it comes to understanding and interpreting research data, the rule is “rubbish in, rubbish out,” says Dr KirstyBobrow of the Chronic Diseases Initiative for Africa (CDIA), one of the presenters at the recent clinical data management workshop hosted in July by the UCT Clinical Research Centre (CRC) and UCTeResearch. The workshop offered insight into four different clinical data management systems currently in use at UCT: OpenClinica; FileMaker PRO; REDCap and OpenMRS. Presentations were given by users, for users, weighing up the various pros and cons of each system.
Effective clinical data management is key to generating high-quality, reliable and statistically sound data from clinical trials and other studies. It is the process of collecting, cleaning and managing clinical data in compliance with regulatory standards. Clinical data management involves a number of procedures including Case Report Form (CRF) design, CRF annotation, database design, data entry, data validation and more. The data that comes out of research projects needs to be high quality data, that is, data that is accurate and suitable for statistical analysis. A researcher does not want to run the risk of having their work disregarded because of missing or inaccurate data.
A number of software tools are available for clinical data management, each with their own strengths and weaknesses. Not all systems are appropriate for all studies, in most cases it is up to the researcher to understand what the various software options offer, and choose the system best aligned to his or her research.
OpenClinica is used primarily for trials as it complies with the tight regulations of the United States Food and Drug Administration (FDA) and other drug regulation agencies, explains Annemie Stewart of the CRC. This is important for researchers working with medication or devices they may eventually want to have registered. It offers a tight audit trail and limited access control. In this sense, it is not an ideal tool for surveys and research in which there are an unknown or unlimited number of data capturers.
“For a database, the design is only the tip of the iceberg,” said Dr Paul Human, director of the Chris Barnard Division of Cardiothoracic Surgery, in his presentation on the pros and cons of Filemaker Pro, an Apple Subsidiary. “The real challenge is data integrity, so it’s important to have an intelligent system.” Unlike some of the open source options Filemaker is not free, but it does offer a number of pricing options including a significant educational discount. Filemaker Pro has been around for 30 years and is a cross-platform system, supporting both Mac (OSX and IOS) as well as Windows. A few other features worth noting are its ability to interface effectively with other database systems as well as its highly efficient storage capability making it a “valuable paperless office system.” All in all Human describes it as a “highly valuable and easy to use piece of software.”
Research Electronic Data Capture (REDCap) is a web-based application developed for building and managing online surveys. It was developed at Vanderbilt University, specifically for research purposes. Presenter, MamanaMbiyavanga, PhD student in Bioinformatics at UCT and bioinformatics software developer at H3ABioNet, described REDCap as secure, flexible and fully customizable, even allowing for mid-study modifications. There are, he says, a few downsides to REDCap. The form layout has some limitations, which could be an issue if a survey requires a complex and precise layout. REDCap is also not made for analysis; the data will have to be exported into the preferred format for analysis. Nevertheless, REDCap can help to extensively improve research through its advanced interfaces by leveraging efforts on study, dramatically reducing costs for study set-up and maintenance, and reducing the hundreds of small data islands at the institution level.
Open Medical Record System (Open MRS) was initially developed as a tool to scale up the treatment of HIV in Africa, conceived as a general purpose electronic medical record system to support a full range of medical treatments. Today Open MRS is a collaborative, open source project to support health care research in developing countries. Presenter, Dr KirstyBobrow, explained how her team used OpenMRS in the SMS-text Adherence Support (StAR) trial that utilizes mobile phone technologies for the self-management of chronic diseases. According to their website the OpenMRS community is a “worldwide network of volunteers from many different backgrounds, including technology, healthcare and international development.”
This was the first of what will hopefully be many such workshops aimed at offering researchers within the Faculty of Health Sciences guidance, training and insight into the various options in clinical data research management.