Electronic data capture (EDC) and management is a vital part of the administrative process in almost all industries, but despite its many advantages, adoption in the health care research and clinical service delivery domains has lagged behind other industries [1-13]. Major obstacles include cost, lack of policy at management level, implementation failure, and data security concerns [1-7]. In addition, research information applications developed specifically for one environment usually require significant resources and support to function in another environment because the technology, support, security, and privacy needs are often different [5,8-10]. Many institutions in sub-Saharan Africa and other low- and middle-income countries lack the technical resources to support information systems for health care research and clinical service delivery [11-13]. Moreover, power and network infrastructure may be unreliable [11-13].

Even with the necessary organizational and infrastructure support, the success of EDC software applications is not guaranteed [4,5,14]. The lack of domain knowledge in resource-constrained environments such as sub-Saharan Africa has hampered the implementation of EDC technologies [11]. There is often a paucity of individuals with the necessary clinical, academic, and IT skills required to support critical health care data management systems [11]. Field-workers and clinician scientists, although highly skilled and valued in their respective domains, may not be well versed in technology for the capture, storage, and transmission of health data [4-7].

Once infrastructure and skills-resourcing issues have been overcome, familiarity with deeply ingrained systems and processes at every level of the research enterprise is a natural cause of resistance to change [1,4-7,15-18]. This includes, for example, the replacement of hard-copy files with electronic data collection instruments for clinical research informatics. Strategies to obviate the resistance to implementation of new technology include demonstrating trustworthiness and benefits of the technology, while at the same time easing the transition through access to appropriate training and support [1,5-7,16,17].

The University of the Witwatersrand (Wits) is a research-intensive university based in the metropolitan area of Johannesburg, South Africa, an upper middle–income environment [19]. The Wits Faculty of Health Sciences (FHS) operates within a health care system weakened by sociopolitical and historical issues and strained by an ongoing quadruple burden of disease [12,20,21]. Setting up systems to support academics in their clinical and research activities is subject to budget limitations and constrained by the geographical distribution of the approximately 2500 health sciences staff and 7000 students, spread over 3 discrete academic teaching platforms and many field sites in both urban and rural regions [22,23].

Before the implementation of the centrally supported EDC system at the University of the Witwatersrand Faculty of Health Sciences (Wits FHS) and the associated research entities in 2012, electronic data management services were fragmentated, inconsistent, and variable. Individuals and research entities were using local devices and legacy systems familiar to them or choosing new products to implement based only on their own needs, abilities, and budget. This fragmentation was not desirable from an organizational perspective because the data sets were isolated, the financial and human resources used for procurement and management were diluted, and the security and privacy of data could not be guaranteed [5,9,10].

During the same period, most of the patient health record data being collected at Wits FHS–related medical centers were paper-based. Clinical staff were burdened by service delivery demands [20] and restricted in the time they had available for research or data capture [24]. Where electronic research data collection instruments were used, they ranged from simple spreadsheet programs such as Microsoft Excel to enterprise-wide data management systems. At the time, there were no preferred instruments within the Wits FHS, and the safety, security, and privacy of the data were at the discretion of individual researchers. There was little standardization of metadata or clinical coding systems, and, as a result, interoperability and secondary analysis of data were rare. This affected patient care and limited the dissemination of important knowledge gained in treating various infectious diseases and diseases of lifestyle that continue to burden the South African health care system [12,20,21].

In 2012, as part of a process to strengthen research support, training, and outputs [8,24], the Wits FHS implemented REDCap (Research Electronic Data Capture; Vanderbilt University), a web-based EDC tool created by informaticists at the Vanderbilt University Medical Center (VUMC) in Nashville, Tennessee [8,25].

REDCap allows users to build electronic data collection instruments for a wide range of data types and environments. It is specifically geared toward research studies and operational data and toward enabling the capture and management of data in a manner that is compliant with 21 Code of Federal Regulations Part 11, the Federal Information Security Management Act, the Health Insurance Portability and Accountability Act, and General Data Protection Regulation [14,25]. Each project will have its own procedures for validation and quality control, and REDCap has many features available to end users to support this, such as granular user rights, a detailed audit log, and data quality control tools

One of the strategic goals of the Wits FHS was to unify and systematize health care and research data collection within the institution [8]. REDCap was an attractive option because of its freeware licensing model for noncommercial use and large international support community [14,25]. The decision to implement REDCap was also supported by an existing diaspora relationship between the Wits FHS and the VUMC [26].

The strategies used to install REDCap and overcome the initial implementation barriers within the Wits FHS have been presented previously [8]. The crucial factors highlighted in the paper were support from the Wits FHS management and the allocation of a modest budget for hosting infrastructure, systems administration, and recruitment of personnel from existing staff for end-user support. Support staff were initially allocated part time on a sliding scale of need, which allowed dedicated end-user support while limiting costs. The hardware costs were limited to servers and security certificates, which were housed at existing university data centers. Four months after the implementation, the number of REDCap users at the Wits FHS was 81, and after 12 months it had increased to 140. The total costs to provide a functional REDCap platform for the first year was <US $9000 [8].

To gain the trust of users, the reliability of the Wits REDCap system was paramount. The system was deployed on 2 virtual machines—one for the MySQL database and a second one for the REDCap application—on a reliable Intel server with 64 GB of RAM and considerable disk space. The Ubuntu long-term support operating system version current at the time was used for both virtual host and physical machines. New hardware was introduced every 3 to 4 years; the cost implications when amortized over the life span of the machine were small. Older, retired hardware was recycled for less-critical work. Multiple levels of backup were used. Daily backups of the database and uploaded files were kept on a separate machine. Three times a week copies of the virtual machine images were created and stored on a server on a different campus. No major hardware failures occurred during this period, but tests were performed to emulate recovery using the backed-up data to ensure that this would be possible in the event that the primary hardware failed. Nagios software (Nagios Enterprises, LLC) [27] was used to monitor system health and stability. The electricity supply in South Africa was periodically unreliable; however, the server was placed in the university’s data center, with multiple backup power redundancies and physical security infrastructure. The REDCap application itself proved to be highly reliable, with regular bug fixes, security, and functionality updates released by the VUMC developers. The human resource allocation dedicated to system administration from 2013 to 2019 was equal to approximately 0.05 full-time equivalents (FTEs).

In 2019, the load created by concurrent users and processes made it necessary to move from magnetic to solid state drives. From 2020 onward, infrastructure and systems administration demands outgrew the existing resources. The Wits FHS REDCap system was moved from the Wits data center to a leading South African cloud hosting provider (Teraco) [28]. Additional systems administration capacity from the Wits Health Consortium [29], a wholly owned subsidiary of Wits, was brought in to manage the cloud hosting environment, with continued guidance and leadership from the original systems administrator. The Wits Health Consortium infrastructure team uses Arcserve [30] for daily snapshots of the virtual environment, with a separate backup every 1 to 3 days on a removable storage device for offsite storage. At the time of writing, the time spent on systems administration totaled approximately 0.1 FTE.

The second crucial component of the Wits FHS implementation strategy was a dedicated go-to individual to support end users, known as the REDCap administrator [8]. One of the most effective types of individuals to place in this role is referred to in the literature as a “technology bridger” [2,9,31]. A bridger is an early adopter who has a deep understanding of the technology being implemented as well as the soft skills to teach and support others at their organization.

The implementation of technology is a form of change management, and by approaching end-user support with an open-door policy and a culture of psychological safety (“a belief that one will not be punished or humiliated for speaking up with ideas, questions, concerns, or mistakes” [32]), the anxiety concerning, and resistance to, change exhibited by end users is reduced [personal communication by Wits REDCap administrator, July 2021].

By encouraging one-on-one consultations with the REDCap administrator in a relaxed and informal setting, new users felt safe to discuss their concerns or expose where they might have a lack of understanding. All email support and one-on-one consultations were provided at no cost. Over time, the need for additional project design and management services for larger and more complex projects became clear. To protect the REDCap administrator from users wanting to make use of the design service, rather than engaging with the administrator, to learn how to use the system on their own, an hourly fee was implemented for design services.

As the number of end users grew, so did the support and administrative needs (Textbox 1). During the period 2013-2014, a part-time REDCap administrator (0.5 FTE) was adequate. This was increased to 1.0 FTE from 2014, and a second full-time administrator was added in 2016. Additional part-time REDCap administrators were added in 2021 in response to a large increase in system use, currently totaling approximately 2.2 FTEs on average.

The REDCap application has a number of built-in tutorial videos and extensive Help and Frequently Asked Questions documentation. However, our experience showed that in addition to one-on-one consultations, the majority of late-adopting end users benefited from in-person formal participative instruction in the use of REDCap design tools. A series of sessions were offered in 2013, the content and format of which informed the creation of formal structured REDCap training workshops in 2014 and thereafter. Although the workshops were well attended, there was a significant proportion of attendees who had made reservations but did not attend. This prompted the introduction of a registration fee, which improved compliance and provided funds to contribute to the sustainability of the REDCap support team.

Initially, a basic introduction-to-REDCap workshop was offered, but as users became more skilled, a more advanced workshop was added in 2015. Good design practices and standardization of metadata were encouraged, and the workshops also established an interpersonal relationship between the end users and the REDCap administration team. A few groups, both within and external to the Wits FHS, requested on-demand REDCap training programs similar in content to that of the workshops. The number of REDCap training workshops and attendees are summarized in Table 1 and Table 2, respectively.

Each year, approximately 5 introductory and 4 advanced workshops were delivered, with an average of 19 and 8 attendees at each type of workshop, respectively. Step-by-step workshop manuals were also compiled iteratively over time and provided to attendees from 2017 onward. A total of 977 individuals attended all workshops between 2014 and 2020: 721 (73.8%) were Wits FHS–affiliated, whereas 256 (26.2%) were from external organizations. Fewer workshops were offered in 2018-2019 because of staffing constraints. From March 2020 onward, workshops were shifted to an internet-based platform (Zoom; Zoom Video Communications, Inc) because of COVID-19 restrictions on in-person gatherings. The availability of web-based teaching resulted in an increase in on-demand workshops—5 were held in 2020 compared with between 1 and 3 in previous years. We attribute this increase in part to the wider access inherent in the web-based format and partly because of the increased number of new users in 2020.

The development of clinical research informatics capacity and health care IT skills are particularly important in resource-constrained settings such as sub-Saharan Africa, and the Wits-VUMC partnership has contributed to the capacitation process at the Wits FHS. Initially, the relationship between Wits and the VUMC grew from an alumni diaspora program initiated in 2010 [36]; it later expanded through bilateral visits by academic staff [26], custom REDCap development projects, joint grant applications, and mentorship. New REDCap Consortium members in resource-constrained environments may benefit from leveraging existing diaspora linkages or from initiating new mentorship and capacity-development collaborations with institutions, such as the VUMC, that have mature research informatics divisions.

REDCap system use is reported in 2 main ways: the number of users and the number of projects. The number of users and projects on any REDCap system is available on the application’s administration web page called the Control Center. The Wits FHS REDCap administrator has a monthly record of several use metrics since system installation in August 2012. Other metrics were determined retrospectively by running MySQL queries on the REDCap database logs with the help of a REDCap external module named MySQL Simple Admin [37]. These queries were used to identify and enumerate project- or user account–creation events. The descriptive system-use metrics that we report on are as follows:

A REDCap user account allows an individual user to access their own private repository of projects and data. The REDCap Control Center displays various metrics regarding accounts; for example, the total number of user accounts, the number of accounts that were active in a given period, and the number of accounts that were suspended because of inactivity. Activity is defined as logging in and performing an action on REDCap. At the Wits FHS, the period of inactivity that leads to suspension is 180 days (this may differ from institution to institution based on policy). We used a combination of Control Center statistics and MySQL Simple Admin queries to report the total number of user accounts on the Wits FHS REDCap system per year as well as the number of accounts that were active in a given year. The measurement is taken on the first day of September each year.

In addition, the growth and decline in the number of active user accounts were determined by taking the number of active users for a given year and subtracting the number of active users from the previous year.

A project in REDCap refers to a set of connected electronic data collection screens and records that are related to a specific purpose.

When creating a project, end users are required to allocate one of five possible project purposes, namely practice, research, quality improvement, operational support, or other. The Control Center report usually excludes practice projects from the total projects metric, but we performed a query using MySQL Simple Admin to retrieve the number of practice projects as well, and we report these together with the total nonpractice projects. We believe that practice projects are an important metric of how comfortable users are to experiment and explore the system, something which is actively encouraged by our REDCap administrators during one-on-one or group training sessions.

Furthermore, we performed an annual breakdown of the nonpractice projects by purpose, and report the percentage of projects in the categories of research, quality improvement, operational support and other.