Maximize Your EHR Systems for Clinical Trials Operations

At the Association of Clinical Research Professionals (ACRP) 2014 Global Conference, representatives from Epic, Cerner, and Allscripts were present to address many myths about electronic health record (EHR) systems. The results from 2014 were posted on the ACRP Online Community for Epic and Cerner. As it turns out, these systems are capable of tasks that many clinical research coordinators (CRCs) and others had believed the systems could not do.

One overarching myth addressed was that the EHR companies are the ones to solve all our prob­lems and hand the solutions to us, but it is not that easy, nor is it their place to solve problems at that level. An analogy is Microsoft Office, which comes with a powerful set of functional tools that must be customized at the institutional and personal level. Microsoft Corporation is not going to design and build an individual company’s balance sheet in Excel, nor is the software manufacturer going to build an Access database and its front-end forms. Microsoft can provide the functionality and some basic training, but how that software is used is an institutional preference.

EHRs are arguably no different. Generally, the functionality desired by principal investigators (PIs) and CRCs is available, but is not used or promoted for a variety of reasons, ranging from not knowing it is there to not having developed it for use.

As a follow-up to the 2014 conference session, a 2015 session focused less on debunking the same myths and honed in on how to build the bridges in an organization and provide the business case for adding research functionality. Today, com­peting resources such as ICD-10 conversion and meaningful-use attestations are taking priority, but nevertheless the business cases can be built for improved research functionality.

This article focuses on three core areas that will pay dividends: 1) Building a Business Case; 2) Strategies for Implementing a (Retroactive) Busi­ness Case; and 3) Building the External Support Network.

Part 1: Building a Business Case

“Executers create energy, they do not drain it.”
—paraphrased from “Execution,” by Larry Bossidy and Ram Charin

First, Mitigate Subject and Business Risks

Patient Safety

For nearly all EHRs, active alerts (see Figure 1) can be built to include notification to the research staff of any of their research participants who enter the emergency room, are seen in an outpatient clinic/ satellite facility, or are admitted to the hospital (provided that the EHRs for the different facilities are linked). This notification is particularity important, given that inpatient hospitalization meets the definition of a serious adverse event (SAE) (as found in ICH E6 1.50 from the Interna­tional Conference on Harmonization).

In order to fully utilize these safety features, patients must be properly designated as partici­pants in a research study and linked to the proper study. This should be done both through the EHR and in conjunction with a clinical trial manage­ment system (CTMS).

Additional safety measures that should be added include hard stops and/or alerts for poten­tial medication contraindications. All hospital medications, including those administered as part of a research study, are ordered almost exclusively through the EHR.

Inasmuh as strict adherence to the protocol is foundational to protect the safety of research participants and to ensure the integrity of scientific findings, deviations from the protocol must be fully identified, promptly reported, and documented accordingly. An EHR e-mail message can be utilized to alert the PI and study team to potential deviations to the protocol in real time, which may result in discovery prior to internal quality inspections or external monitoring.

Electronic research order sets can be specifi­cally built to protocol specifications to prevent per­sons not involved in the study from inadvertently altering study orders. This not only saves valuable time, it also enhances safety by providing an elec­tronic means of tracking protocol requirements and preventing noncompliance. Mechanisms for building order sets vary among institutions and may require programming expertise. Some institutions may incorporate electronic order sets or “builds” as the expense of doing business, while other institutions relegate the build to each research team.

Each institution must decide if the utility of order sets should be internally supported or if research teams must secure their own expertise and/or funding. Research order sets and orders associated with research also play an important part in facilitating billing compliance. The addi­tional function is institutionally dependent, based on whether the EHR is directly linked to billing modules.

Billing Compliance

Billing compliance, especially when it involves the billing of federal payers, is a complex matter that creates many challenges (see Figure 2). Although entire conferences are dedicated to effective billing practices, participants remain confused on many counts. Even when the regulations and coverage decisions can be navigated correctly, it is difficult to implement a compliant billing system in a fast-paced and complex healthcare organization because of the many handoffs.

Any compliance officer in a healthcare-related entity should be well versed in the Stark Laws, False Claims Act, and Anti-Kickback Statute, as well as their penalties. Integrating research into this already complex system increases the risk for double-billing. Examples include billing Medicare for something for which the sponsor is paying the hospital and/or the research site/physician, billing for nonreimbursable investigational products or for nonroutine care items, or billing Medicare when a sponsor agrees to pay for a clinical trial–related injury (which violates the Medicare Secondary Payor provisions).

There have been many well-documented cases in which providers have had to pay millions of dollars in fines and/or settlements due to inaccura­cies in research billing. EHR systems often touch all points at the beginning of the billing cycle and per­sonnel involved in the beginning of the billing cycle (such as clinical staff, coders, and others in charge of revenue integrity); therefore, the EHR is often that single source of all billing-related truths, including items significant to research-related billing.

Healthcare System Accreditation

Hospital accreditation agencies such as the Joint Commission and Det Norske Veritas (DNV) Health­care provide specific requirements for research operations (see Table 1*). For research consent documents, the Joint Commission’s standard (RI.01.03.05) and DNV’s standard (PR.4) address the hospital’s obligations independent of what the U.S. Food and Drug Administration (FDA) or Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services, may require.

Both agencies also have standards that pertain to the management of investigational drugs. The Joint Commission’s standards (MM.04.01.01 and MM.06.01.05) require a hospital-specific policy for investigational drug orders and management. Sim­ilarly, DNV’s standard (MM.1) indicates that overall policies must include investigational medications/ drugs that are not eligible for scheduled dosing times and provide general guidelines for what medication policies must include.

Specific tabs in the EHR can be utilized to easily identify research consents and medication records. For those nonhospital entities accredited by the Accreditation Association for Ambulatory Health­care (AAAHC), Section 19 puts forth requirements similar to those of the Joint Commission and DNV regarding documenting the informed consent process for research participants who are indepen­dent of FDA and OHRP requirements.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Non-HIPAA Privacy and Security

Providers in the United States’ healthcare delivery environments are no strangers to the privacy and security restrictions put forth by HIPAA. HIPAA is also intended to provide the parameters for the appropriate use and disclosure of health informa­tion for legitimate purposes, such as research. The process of releasing those data (usually pursuant to a signed authorization from the clinical trial participant) must be done in a HIPAA-compliant manner.

In a paper-based world, this introduces privacy risks for the patient and regulatory risks for the pro­vider. Shifting the records with patient-identifiable protected health information (PHI), be they medical records or other paper source documents, into the EHR environment provides a secure storage mecha­nism that places the provider more in control of who is accessing that information.

The security of the subject’s record may be ensured by issuing study monitors with their own user identification and password, so that their activity can be limited and tracked (even if they log in remotely) or by having them review the material over the shoulder of a staff person with access. Heads of organizations that have transitioned to EHRs would likely shudder to think that they would keep shadow paper copies of identifiable medical records of their patients. Arguably thus, the risk of a PHI breach to the research subject and the institution is no different if the PHI was on a medical record page or a research source document.

Although health information that has been de-identified according to HIPAA standards goes unregulated by HIPAA, there are still risks to be addressed. Large research datasets that otherwise could have been part of the EHR reside in the proverbial “locked filing cabinet” or in Excel spread­sheets and other database programs on laptops and USB “thumb” drives. The literature is full of incidents of lost research laptops.

Even if the data are de-identified, a business risk is still posed to the institution as well as the individ­ual, given the ease of combining the information with other publically available datasets for what is known as “re-identification attack.” Overall, having the research source data as part of the EHR protects not just the privacy of the subjects, but also the actual data, from potential breaches.

Other Regulatory Considerations

FDA Form 1572 for investigational drug clinical trials and “The Statement of the Investigator Responsibilities” for investigational device clinical trials are, respectively, signed acknowledgements that investigators will adhere to FDA regulations regarding the conduct of investigational agents. Per 21 CFR 312 in the Code of Federal Regulations, investigators are required to delegate appropriate tasks to others based on their education, training, and qualifications.

The Delegation of Authority Log lists all persons to whom the PI has delegated significant trial-related duties (ICH E6 4.1.5). In some cases, discrepancies exist between the log and institu­tional policies for study team members. A CRC who is delegated medication dispensing responsibilities by the log may lack the credentialing necessary to enter medications in the EHR.

The log must be consistent with internal policy for the EHR to be fully effective. Depending upon the organization and the state it operates in, any activity documented by an unlicensed coordi­nator may need to be reviewed and signed by the appropriately credentialed and licensed staff to ensure that activity is not beyond the scope of services of the job description or licensure of the individual. Role-based security may be consid­ered burdensome by study teams at first, but the safety, consistency, and transparency provided by EHRs ensure better alignment with institutional guidelines and protections.

Second, Capitalize on Business Opportunities


EHR records support a vibrant environment for quick and accurate feasibility assessment for potential clinical trial offers. The skill set of information technology (IT) analysts decreases the work effort spent on behalf of the research staff by querying the existing data within an active EHR.

An accurate assessment of feasibility creates an environment of respect and trust among research centers and industry leaders. A researcher can submit the initial feasibility questionnaire to the IT analysts, or an automated process may be developed. Reports may be available in real time or by the end of the business day, depending on institutional policies and procedures.

The feasibility report provides accurate data regarding the center’s potential study subject pool. If the report does nothing else, it prevents institu­tions from accepting studies for which they cannot adequately recruit, not only saving these institu­tions time and expense, but also preventing them from gaining a reputation of being a “low enroller” or “zero enroller” in sponsor and contract research organization (CRO) databases.

Uploading EHR data to a cohort discovery tool, such as the National Institutes of Health (NIH)-funded i2b2 (Informatics for Integrating Biology and the Bedside) (see, provides a fast and convenient way to identify a specific cohort of interest. A customized search for demographics, disease states, or lab values reveals the number of potential participants meeting the specified criteria. i2b2 searches millions of unique data elements at once without involving the use or disclosure of any PHI, and before an institutional review board (IRB) application is needed.

Based on the results, the investigator can make a more informed decision whether or not to proceed, saving countless hours, preventing studies “doomed to fail,” and greatly aiding in the selection of inclusion/exclusion criteria likely to make enrollment successful. In the past, this was possible only through IRB approval and exhaustive paper chart review. Once the decision is made to proceed with the study and IRB approval is obtained, the investigator can access PHI for the identified cohort.

Clinical Trials Recruitment

Many practitioners attempt to recruit participants through an EHR’s patient portal. Participants receive a message through their portal indicating that they may be eligible for a study. Interested participants can consent online and complete the study questionnaire or other tasks related to recruitment.

The capability to engage the participant in the clinic is particularly exciting, given recent interest and funding opportunities for patient-centered out­comes research (PCOR). As IRBs are charged with the protection of research risks to human subjects, it will be essential to engage IRBs to assure that adequate informed consent and appropriate confidentiality measures are in place for this new era.

In the fast-paced emergency department setting, patients are not scheduled, and volume and acuity cannot be predicted as accurately as in other healthcare settings. An EHR’s built-in notification system can greatly aid the ability to identify participants by alerting the study team to a patient’s real-time presence via phone or e-mail after a certain diagnostic test/procedure (i.e., urinalysis) is ordered or a certain diagnosis made. Once the move to an EHR system is announced, research teams should petition leadership to have this type of functionality incorporated.

A paging communications workflow utilizing an order transmittal rule was built into the new EHR system to facilitate paging of emergency department study teams when an order for a cer­tain test or medication is placed. A recent example utilizing an alert concerning any patient having a urine culture allowed the emergency department to enroll 90 participants in a kidney infection study much faster than anticipated. Once study enrollment was complete, the alert was simply inactivated.

A physician can also directly communicate with study teams by entering a nursing communication order. The order becomes a part of the EHR and documents that the provider has communicated with the patient and that the patient has given approval to be contacted by the study team. Because the order meets the order transmittal rule, an alert is sent to the study team.

Recruitment of study participants via EHR can also include direct notification of the physician. A significant challenge of recruitment involves simply maintaining provider awareness of active studies and their inclusion/exclusion criteria for screening. The potential exists for EHRs to maintain an active surveillance of scheduled patients and alert the provider to those who may be eligible for a study.

The applicability of this approach will vary by study. For example, an EHR may be able to discern all screening criteria for a prospective registry-based observational study, but only be able to pro­vide high-level screening capabilities in the case of a randomized oncology treatment clinical trial (see Case Studies #1 and #2 for examples).

Trial Metrics

A benefit of EHR in the healthcare setting is the derivation of metrics from existing data. The monitoring of metrics is an important and useful practice in any business setting, though care must be exercised to focus on relevant metrics. Sometimes administrators simply need to ask, “How many clinical trial patients have we had?” or “How much revenue did this study bring?” or (after reading a bad press report) “Did we have anybody on that particular study in our hospital?”

Aspects such as productivity, efficiency, and even qualitative measures could also be utilized for more sophisticated inquiries and planning. Many clinical trial sites use a CTMS for such measures, but many sites do not have the benefits of such a robust system. For whatever reason, a number of sites unfortunately do not conduct metrics, and the end result is a poor awareness of their perfor­mance. This can be true for the site as a whole or for individual studies.

Reasons for not implementing metrics can vary, but a lack of time may certainly be one. The EHR can potentially automate the process, especially in the absence of a CTMS. Individual measures of study performance, such as enrollment rate, can be aggregated to provide a view of site performance. A dashboard can be developed for the site to monitor itself. In addition, data from different sites can be used to develop benchmarks for performance.

Optimization of Workflows for CRCs and Clinical Research Associates (CRAs)

CRCs often have to abstract data from EHRs to enter into case report forms (CRFs). Conversion to EHRs makes this task easier. While this is generally a standard feature of EHR functionality that does not need extra builds above and beyond those required for normal operation, sometimes there are internal obstacles that slow down CRC access to the EHRs (see Case Study #2* for an example of the improved efficiency).

To also enhance the utility of EHR in research studies, it would be beneficial if data could be uploaded from the EHR into the electronic CRFs (eCRFs). This is technically feasible, and has been demonstrated in pilot studies by the Clinical Data Interchange Standards Consortium (CDISC); however, it has not been adopted by sponsors and sites in any meaningful manner.

The upload would have to be managed by the department in charge of health information management to ensure security and accuracy of information, as well as to ensure that only mini­mal necessary information is uploaded. The data upload would ensure accuracy of data, reduce time needed for data entry (especially “double entry”), and allow CRC efforts to be focused on data verifi­cation and completion of additional elements prior to submission of eCRFs. The use of tablets and other mobile devices is now possible for many EHRs. This may increase functionality in active settings, where sitting at a desktop is neither practical nor optimal.

Although tablet use may involve providing a custom build to the EHR system instead of creating separate eCRFs on the tablet, there are also technologies that can enable an eCRF to be automatically completed within the user’s current application, saving the need for double entry or manual uploads from the EHR. Again piloted by CDISC and again not yet widely utilized, the “remote form for data capture” technology promises to be the one of the most influential tools for integrating the workflow processes of clinical care and clinical research.

As part of the protocol monitoring process, monitors or CRAs may be required to review records, but it is often challenging to isolate only the records of subjects in the clinical trial. Mon­itors have either had to look over the shoulder of a research staff member (which is not the most optimal use of the research staff’s time) or been subjected to a security background check (requir­ing them to give their Social Security Number) in order to be granted direct electronic access.

Setting up a system to support remote monitoring of EHR data is feasible (and is often done for peer or legal review), and the costs can be shared with the sponsor or CRO. Given the lost productivity and high costs of travel (typically $700 or more in direct travel costs for a two-day monitoring session), any investment in remote monitoring sessions can be seen as a win-win scenario for sponsors/CROs and sites.

Clinical “Blue Ribbon” Mandates

Achieving certain quality designations, whether mandated or voluntary, is an important focus of leadership in healthcare organizations. Programs responsible for designating Centers of Excellence or other national and international designations have become industries unto themselves.

To earn many of these “blue ribbons,” be they in clinical areas (such as cancer, stroke, or trauma) or for professionals (such as the Amer­ican Nurses Credentialing Center’s MAGNET Recognition Program), the institution must be engaged in varying degrees of research. While some of the research requirements are very onerous, many can be accomplished with simple utilization of existing health data.

Before EHRs became available, data collec­tion, processing, abstraction, analysis, storage, and transmission was an expensive manual process, even for retrospective research, due to the onerous task of digging through medical records. With the right capabilities, the EHR can be a powerful and inexpensive source of easily extracted and analyzed data that meet these requirements.

PART 2: Strategies for Implementing a (Retroactive) Business Case

“The best time to plant a tree was 20 years ago . . . the second best time is now.”  —Chinese proverb

Work Within the System that is Greater than the Research Department

Regarding the conversion to EHRs, David Blumen­thal, one of the architects of the Health Informa­tion Technology for Economic and Clinical Health (HITECH) Act and the former National Coordinator for Health Information Technology, stated, “These IT implementations are rare, once-in-an-organization’s-lifetime opportunities . . . [to clean up messy systems and to make fundamental decisions about workflow and governance]. I just wish more organizations would take advantage of them.” Blumenthal also stated that the implementation of health IT is “not a technical project, it’s a social change project,” meaning that the IT department is not just downloading software and clicking “I Accept” the Terms and Conditions.

Many of the challenges faced by research staff result from their not having a voice at the table when decisions are being made about EHR systems that directly or indirectly affect the staff. Most hands-on users of the EHR system are not in senior-level decision-making positions; thus, there exists an inherent disconnect that is linked only by the voices at the table, either in person or by proxy.

Given the higher priorities and louder stakeholders at hand, it seems that research staff have to be assertive and invite themselves in order to have a place at the table. Assuredly, one of the best ways to have one’s voice heard over the myriad of other demands is to personally be there to give it; therefore, research staff should find out when these meetings are to be held and/or who is in charge of the agenda.

Alternatively, a list of research needs can be inserted into status reports to make sure the research department has a voice (see other sections in this article that reference Physician Champions and discuss parallels for synergizing voices). Having a spot on the written plan, even if that spot has low priority and results in no action, is argu­ably better than not having a spot on the plan, as somewhere, somebody is evaluated on that plan.

Other challenges include not knowing whom to ask for answers or solutions. It is not uncommon, especially in large organizations, for several IT personnel to respond to an inquiry by saying that the EHR system “can’t do that” and for the next person (IT or otherwise) to respond by showing that it could have been done all along. Persistence here often pays off, and these systems often can do what is wanted (as-is or with some tweaking).

Clinical staff who best know the function­ality and/or an operator who best understands the business impact can be valuable resources to overcoming challenges. IT personnel work hard, yet are unfamiliar with the specific needs of end-users. Effective partnerships—including detailed requests, engaged IT personnel, and strong working relationships—are key to overcom­ing many challenges.

Find One or More Physician Champion(s)

The implementation of an EHR likely represents a significant capital investment by the institu­tion, based on input from leaders across many departments. Finding a voice and forum to convey needed changes can be difficult in even the most accommodating firms. Individuals in firms with­out an existing or effective change-control process may be relegated to simply discovering creative workarounds.

Enlisting a Physician Champion (especially one who is computer savvy) is often the best, and perhaps only, way to affect positive changes. A strong case with sufficient documentation and justification is still required, but a Champion will get the message to those in a position to act and follow through. An advocate who is both a respected clinical leader (knowing what is needed) and an acknowledged business leader (knowing what is possible) can present the message strongly and to the right individual(s), who are empowered to make selections of vendors and/or who have the authority to allocate resources.

Find Parallels to Make Research Needs Easier to Assimilate

Often, the research-related requests for EHR functionality are not necessarily unique. A request may often be stigmatized because it comes from the research office when, in fact, with little to no creativity there is existing functionality that can be piggybacked. For example, a research department’s request to split bills between a research sponsor and the patient’s payor could be met with unnecessary obstacles, although the request could involve simply finding out how bills may be split for routine-care procedures, such as a hysterectomy (which insurance covers) and a tummy-tuck (which is cosmetic and often not covered) during the same hospital stay.

Once a research staffer has found a parallel, it is much easier to add research to existing policies and practices than to try to define a whole new process for research. Simple things such as notifying research staff of subsequent care a patient/ subject receives and ensuring the availability of custom order set functionality, processes for remote viewing of medical records, functionality of pop-up warnings, etc., are all items utilized in routine care from which the research staff can benefit.

Shifting the request from something like “for research, because we’re different, we need to add…” to something like “you know how we accommodate for [nonresearch activity that the EHR already supports], well this is essentially the same thing” could make all the difference.

Identify Research Functionality Gurus/Super-Users

For the successful implementation of EHRs, end-users need to be appropriately trained on the basic functionality of the EHR system being utilized (identifying patients, obtaining results, accessing information, etc.). Additional job-spe­cific training is needed (e.g., how to enter billing codes/insurance information for personnel in the billing department and how to dictate notes/write orders/transfer charts for personnel in the clinical area).

However, if individual personnel are familiar with only their “piece” of the system, no one will have the overview necessary to know how tasks within the EHR are inter-related, find more efficient ways to perform tasks, or identify potential “gaps” in the system. The super-user or EHR guru needs to have a high level of computer literacy, be able to communicate information in an understandable way to end-users to facilitate their learning, be able to understand difficulties and identify solutions, and be a leader and champion for the implementation of the EHR.

If the user groups have someone who can be a super-user, the system will be easier for those with limited computer literacy to implement. The super-user also needs to be comfortable and confident enough about his or her abilities to search out answers or solutions from blogs, other super-users, or EHR representatives. If an institution does not have an identified super-user, it would be best to identify one right away, even if that person tempo­rarily has to be you, the reader.

Present Your Needs as a Solid Business Case

Business can improve only to the extent that performance improves. Two factors come into play in this regard. The first is knowledge of the quality of existing performance, and the second is the ability to act on that knowledge. The use of EHRs in clinical research can fulfill both of these factors.

In the first case, the ability to collect and aggregate data into meaningful metrics provides the ability to develop an awareness of one’s performance level.  In the second case, EHR capabilities can be utilized to act on and improve such measures, both quantitatively and qualita­tively. Individual study performance, enrollments, staff performance, and participant compliance are examples of measures that can add value to a busy clinical research site.

The business case (see Table 2*) for the use of EHR for research enhancement, site performance, and metrics development also incorporates an indirect aspect. This is the relationship of a research department within the overall healthcare organization. Simply put, hospitals and healthcare systems have expectations of their departments in terms of efficiency, cost reduction, and improved performance. By extension, decisions about reductions in departments may be based on these aspects, especially for healthcare systems operating on thin margins.

That said, an additional challenge faced by research sites is the need to educate leadership about the business of research, which is an area with which many healthcare leaders may not be familiar. The use of EHRs in research is a means to address these concerns of healthcare leadership relevant to research. Again, the usefulness of EHR in this regard involves the development, imple­mentation, and utilization of practical metrics.

Part 3: Building the External Support Network

“Be the change you want to see in the world.”  —Gandhi

Ensure That Implementation is in the Hands of Implementation Experts

People generally agree that if you do something right the first time, you save time and money that would otherwise be spent in redoing the work. While CRCs are generally seen as jacks of all trades, even computer-savvy CRCs rarely have experience in EHR implementation and functionality. As stated above, there should be an identified super-user, who will likely be a CRC, but the super-user role should not be confused with the implementer role.

There are generally expert implementers (or at least identified/trained implementers) within the IT staff, project management personnel, and/or nursing informatics specialists charged with the migration of functionality. Assuming that research is on their punch-list, let them do the job that they do best instead of trying to change a CRC or PI into an EHR imple­menter. Taking a CRC out of a revenue-generating role to learn how to be an EHR implementation expert is unlikely to be time well spent.

Find One or More Helpline(s)

All EHR vendors have technical support (online or in-house) and even some research functionality support available for implementation, troubleshooting, and maintenance of the system. In addition, a number of online communities (blogs, forums) are available through the different EHR vendors (as well as independent organizations). Many vendors have live meetings that have research-specific breakout sessions. Even if a user cannot go to the meeting, he or she can ask an attendee to pick up the materials or ask the vendor to send them.

Share Training/Tips with Others

Sometimes EHR support forums may be nonexistent or inaccessible to the research staff, either by omission or by institutional design. Instead of (or as a supplement to) vendor-supplied assistance, most professional societies (such as the ACRP) have discussion forums that can provide help from peers in similar positions.

Further, institutions are partnering to share best practices. Effective change realized in one place is often easily duplicated elsewhere. Research professionals with an interest in and a working knowledge of EHRs must continue to build bridges among peer institutions and alongside other forums. These mavens can advance the cause in many ways, such as by volunteering to be lead­ers, conducting solution-finding sessions at local professional chapter meetings and conferences, or writing grants for implementation through the NIH or the Clinical and Translational Science Awards (CTSA) program, among other examples.


In the book “Management: Ready Aim Fire,” Anthony La Russo states, “. . . managers can find that they have set a long term path for their organization by making a series of decisions focusing on numerous separate short term problems.” He goes on to state, like so many others, that you have to initiate the change you need rather than wait for your organization to evolve (look what waiting for evolution did to the dinosaurs). Thus, although people often state that “someone needs to fix this” and “someone needs to lead this effort,” they frequently forget that they are “someone” as well.

It is up to clinical research operators to make their needs known, struggle to the top of the list, and lead the change in their organization. By presenting a solid business case, you can differentiate your needs from those of others who cannot articulate the value of the investment to the organization.

Research professionals must work within their own institutions to build and maximize EHR benefit(s) and spread their success stories across the broad research landscape. This must be done to enhance the benefit and safety of all research participants, to meet the scientific and ethical responsibilities of research professionals, and to derive maximum benefit and efficiency among research teams.


The authors thank Gregory A. Folz, CCRP, adminis­trative director the Research Institute of Deaconess Clinic in Evansville, Ind., for his contributions to this article.


David M. Vulcano, LCSW, MBA, CIP, RAC, is an AVP and the Responsible Executive for Clinical Research at Hospital Corporation of America in Nashville, Tenn.

Candida Barlow, MSN, CTN, RN, is director of clinical research at St. John Clinical Research Institute in Tulsa, Okla.

Natalie F. Scully, PhD, CCRC, CCRA, is a clinical research oversight specialist at the Texas Heart Institute in Houston, Texas.

Cynthia M. Soto-Azghani, BSN, RN, CCRC, is a clinical skills specialist and adjunct faculty at Tyler Junior College in Tyler, Texas.

Anthony Keyes, BS, PMP, is employed at the Johns Hopkins University School of Medicine in Baltimore, Md.

Steven Ziemba, PhD, FACHE, CIP, CCRC, CPI, is an associate director at Marshfield Clinic Research Foundation in Marshfield, Wis.

[DOI: 10.14524/CR-15-0048]

*To see all figures and/or tables published originally in this article, please visit the full-issue PDF of the June 2016 Clinical Researcher.