Bridging the Gap Between IT and Clinical Operations

November 1, 2001

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-11-01-2001, Volume 8, Issue 11

Mutual understanding of roles and responsibilities across the boundary between IT and clinical operations allows both departments to function more effectively.

Mutual understanding of roles and responsibilities across the boundary between IT and clinical operations allows both departments to function more effectively.


Information technology has been the driving force behind the remarkable productivity improvements of the past decade. These gains are largely attributable to the fact that the technology has become more fully featured and easier to use, which has resulted in greater user proficiency. There is still, however, a significant gap in the relationship between the developers and the users of information technology, particularly in the clinical trials arena. Indeed, IT and clinical operations are both highly technical disciplines, the workings of which are not easily accessible to the uninitiated. Yet observing some rather simple rules of engagement can bridge the gap. This article looks at a number of areas in which communication bridges can improve interdepartmental relationships:

  • Jargon and acronyms
  • Liaisons and dual-function positions
  • Training outside an employees area of responsibility
  • Tracking software changes
  • Software prototypes
  • The ripple effect of changes
  • Negotiating deadlines.

Clinical operations and IT have their own distinct languages and abbreviations. Clinical researchers can speak to each other meaningfully using such abbreviations as GCP, NDA, and IND. IT professionals know what one another mean when they speak of VPN, GUI, and bandwidth (see Glossary). Although this kind of verbal shorthand helps facilitate intradepartmental communication, it often poses an impediment to effective interdepartmental dialogue. When clinical operations and IT interact, they should limit their use of technical jargon and abbreviations. For example, saying that access to the host computer is slow because the new program transmits much more information across the connections is infinitely more comprehensible to clinical personnel than saying Your VPN does not provide sufficient bandwidth to support the new GUI. Although the simpler explanation may not be technically precise, it conveys the general sense of the problem.

The more clearly and simply such issues are explained, the better the interaction between the clinical and IT worlds.

Liaisons, dual-function positions
In the era of specialization, the value of generalists is often underestimated. But a few well-placed corporate positions, filled by persons with a wide scope of knowledge, can be extremely helpful. This is especially true in the no-mans-land between IT and operations. Here a business analyst or IT liaison reporting either to IT or to operations can create and maintain a dialogue between the two departments and objectively assess issues from both perspectives.

Such liaison is particularly crucial when a new piece of software needs to be developed. Knowledge of both the best business practices and the difficulties of software development allows the two departments to evaluate the impact of new software long before the first line of code is written. A generalist with a foot in each camp can communicate to operations some of the constraints that developers face as they attempt to resolve conflicting requirements or work with limited resources. In this role, the IT liaison serves as a translator familiar with the language, culture, and idiosyncrasies of the respective parties.

Training, training, and more training
In clinical settings, although training is routine and essential to success, all too often training opportunities are limited to areas for which the employee is responsible. But informal cross-training between departments can be extremely beneficial. That is not to say a contract research associate should be trained to do C++ programming or that a senior programmer should know the normal pediatric ranges for all blood chemistry analytes.

Informal monthly seminars, alternating between clinical and IT issues and conducted by nonsupervisory personnel, can serve as forums for exchanging vital information. Topics might include logistics issues (such as sample transport), software testing and validation, construction of case report forms, and how the Web works. Issues that are normal routine to people who deal with them every day can be steeped in mystery for those who do not. Informal seminars can provide valuable insights for those involved in interdepartmental communiation.

Pairing people in IT and clinical operations for a day can also yield significant benefits. The IT person could spend the morning with a clinical person, learning firsthand about operations challenges. The roles would be reversed in the afternoon, so the operations person could observe the IT person at work. This type of cross-training helps create an invaluable corporate culture of teamwork.

Change-tracking systems
When a clinical operations department requires a modification to some software application, they typically submit a formal request in writing to IT. In turn IT proceeds to process the request, as time allows, without realizing that operations is often unaware of the status or progress of the request. Inevitably that leads to frustration. The solution to this type of situation lies in communication between departments. Clinical operations needs to state its need for regular updates on the status of the modification and the anticipated implementation date. Most software development enterprises have some type of bug-tracking software that allows them to enter detailed information about a change request and to track it each step of the wayfrom user requirements and functional specifications through code development, peer review of code, unit testing, system testing, user acceptance testing, and any other steps. Such tracking software often indicates the current owner of the change and the anticipated release date.

IT can generate weekly reports with a small subset of informationfor example, change request description, current owner, status, anticipated implementation date, and IT contactto keep clinical operations apprised of progress. The information can be put on an intranet site, where all employees have immediate access to it. Weekly reports may not accelerate the process, but they can dispel uncertainty by projecting an implementation date.

Using prototypes
Software developers need a clear understanding of the way an application will be used in the real world. When clinical operations needs a new application, or revisions to software currently in use, it is customary for IT and clinical operations to schedule a series of joint meetings to determine user requirements. To ensure that the software works the way operations intends, the two departments need a continuing dialogue. If IT develops a finished application based on only the initial meetings, the software may not work as needed.

Before laying down actual code, developers often perform what is called a proof-of-concept design. This involves making a prototype of the software simply to ensure that the design is feasible and will function as required. At this stage, operations personnel should be brought back into the loop so they can test the application.

Even though bugs may still exist and not all features have been included, operations staff members can get a sense of whether the finished product will meet their needs. For large projects, several such meetings should take place during the software development cycle. Although the frequent interaction may lengthen the timeline for the project, when the software is delivered, user acceptance is virtually guaranteed.

The ripple effectthinking ahead
One of the most difficult issues confronting IT is the ripple effect of software modifications. A simple change requested by operations might affect many of the other modules, windows, or functions in the system. A change to the way a clinical report form displays data on a computer screen, for example, can affect every other place in the system that uses the same data elements. So a seemingly simple change can actually be a difficult IT assignment in a large, complex system. In these situations, the business analyst must assess all of the operational and software impacts. Otherwise, the development process will be slowed, and additional modifications may be required after the software has been implemented.

Negotiating deadlines. Given the urgency of change requests and the limited time and resources most IT departments have to fulfill them, IT and operations should hold regular meetings to discuss priorities and deadlines. IT needs to understand what is causing problems in operations, and operations needs to understand the difficulties involved in completing certain projects. As a team, they can negotiate aggressive but realistic deadlines. Once they set priorities, they should adhere to them, thereby averting midstream changes in focus that can be wrenching and costly to everyone involved.,P>In the data-intensive business of clinical trials, an optimum relationship between IT and operations is vital to deliver the kind of results that are critical to the success of a clinical trial. That means learning to speak one anothers language in simplified, nontechnical terms. It means designating an interdepartmental liaison person knowledgeable in both clinical operations and software development. It means cross-training to foster understanding and appreciation of one anothers roles in the organization. It calls for tracking and communicating the status of IT projects and using prototypes to ensure that finished software meets users expectations. And it means evaluating the impact of changes on the overall system. Both the clinical operations and IT departments will function more smoothly and efficiently when understanding and communication bridge the gap that too often separates them.

SIDEBAR: Glossarybandwidth A term used to reference the volume of data that can be passed back and forth between systems or computers. 56K (a typical modem bandwidth) would pass about one quarter of the volume (and therefore speed) of a 256K frame relay line. Its comparable to lanes on a freewaymore cars can travel on an eight-lane freeway than a two-lane freeway. At rush hour it makes a huge difference.
C++ programming C++ evolved from C. An object-oriented programming language (as opposed to a linear programming language like COBOL or BASIC) that is used to create many client-server applications.
GUI graphical user interface. The part of the software application a user actually sees on the monitor and works with to enter data or perform certain functions.LAN local area network. Networks that connect computers that are physically close (normally in the same building).
VPN virtual private network. Hardware and software that allows computers to be linked via the Internet (public access), but have security and protection that emulates a direct connection (private access).
WAN wide area networks. Networks that connect computers that are physically distant.

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