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International Clinical Trials

Know Your Numbers


While great strides have been made to transition some areas of clinical trials from hard copy to electronic form, onsite regulatory document management is one facet that remains electronic-naive. Introducing a remote-access, web-based system drives cost savings for sites conducting research while improving protocol compliance.

Finding new efficiencies is a cornerstone of the new paradigm of clinical trial management. Pharmaceutical companies are shedding clinical trial oversight staff and formally partnering with CROs to assume those responsibilities. However, with that partnership comes the requirement for CROs to tighten belts and focus on being more efficient. They must streamline, cut costs and still meet enrolment requirements. As a result of this movement, CROs look to research sites to follow suit.

The sites face increasing costs, resulting from inordinate amounts of sponsor-required paperwork and increased retention time for documents, both of which consume fixed as well as human resources. With a heavily paper-driven system, the opportunity for error increases while the productivity time of study coordinators decreases. For example, a site conducting 10 trials may actually be losing close to two full weeks per month of time that coordinators could otherwise spend on screening and enrolment. Add to that the necessity of research sites having to occupy prime locations or pay for off-site storage to house multiple binders for an extended period of time, and sponsors are faced with higher budget requests from sites as a direct result of documentation management (1,2).

Paper Mountain Trekking

Innovative research sites are turning to electronic document management to introduce efficiencies and assure more coordinator time is dedicated to the priority of screening and enrolling subjects into trials. Benefits of an eDocument system go beyond simply introducing efficiencies. With reduced paper, adherence to standard operating procedures (SOPs) and automated workflows, electronic document management greatly enhances cost-effectiveness, compliance and coordinator productivity. Even with the growth of the environmentally-friendly movement, the clinical research industry has been slow to adopt so-called ‘green’ initiatives. On the contrary, all indicators point to an increase in paperwork for research sites caused directly by the growing demands from sponsors and increased regulation handed down from the governing agencies overseeing the clinical research enterprise. The resulting impact on human resources, space and supplies such as paper and printer toner, as well as the wear and tear on printers necessary to manage the mountains of actual paper associated with trial coordination, is significant. While the industry has made some strides toward moving more into the electronic world, such as using electronic data capture and clinical trial management systems, some tasks remain intensely manual. One such fundamental area is regulatory document management.

In the past, the regulatory binder for a trial consisted of a single three-ring binder that was simply stored at a study coordinator’s workstation for easy access and reference. Today, it is not uncommon for each trial to require multiple three-ring binders to house regulatory documents. Conducting multiple clinical trials at any given time creates challenges for coordinators relative to easy binder access, as well as the inordinate number of documents to be organised and filed regularly.

Greater amounts of paperwork coupled with extended document retention periods have become not only a time drain, but also a financial drain for sites. With study coordinators forced to dedicate more attention to administrative duties related to document management, less time is spent on actually screening and enrolling. Successful enrolment is the ultimate productivity measure evaluated by a sponsor and drives the site’s potential for trial revenue on current projects, as well as future selection to participate in new trials. The need to store greater volumes of study documentation for longer periods of time requires more space, whether on site or purchased off site. A direct correlation exists between the increased amount and retention of paperwork and the decrease in trial profit margins that sites are experiencing (3,4). As a result, sponsors are noticing a spike in sites requesting higher budgets to cover those costs.

As technology and clinical trial management evolve, the need for electronic solutions in the realm of clinical trial management becomes increasingly important. A particular concern is the need for cost-effective, resource-sparing electronic options to manage the day-to-day document flow. In light of site selection for trial placement becoming a more careful process, sponsors and CROs are looking to sites that have the competitive advantage. A site rises to the top of the selection list if it can exhibit processes that embrace compliance in conjunction with maximising efficiency.

Sites continue to be required to maintain multiple bulky binders that are often bursting at the seams with study documents. It is not uncommon for study coordinators managing multiple trials to devote close to half of their time to the administrative tasks of managing study documentation in a manner that satisfies sponsors. Additionally, higher volumes require increased oversight by way of monitoring visits by study sponsors, which results in greater expense for the sponsor and further consumes the coordinator’s time.

Another drawback to increased paperwork and the administrative management that must follow is the retention time requirements of documents. It is not uncommon for a sponsor to require that sites maintain study documents for upwards of 15 years regardless of whether a drug is approved for marketing before this period of time. Due to limited space, many sites are forced to seek the services of off-site storage facilities to house documents. Sites must evaluate and select storage facilities that ensure documents will be maintained according to sponsor specifi cations. The end result is higher, long-term costs incurred for a site. These costs must either be incorporated in the site’s clinical trial budget requested from the sponsor, or the site will have to absorb it as an unrecoverable expense (2,5).


Reality Check

Quantifying the amount of time spent on manual regulatory document management versus electronic document management offers important insights. In one assessment, managing paper-based regulatory study documents were collected from the real-time management of 15 industry sponsored trials over the course of 90 days. Work was broken down into one-time tasks and ongoing monthly tasks associated with maintaining regulatory document compliance for each of the 15 trials. As tasks were performed by research personnel, start and stop times were logged into a time tracking tool developed for this purpose. An average of the time for each study-associated task was determined to derive the overall time assigned to each task. The task times were added to provide a cumulative time associated with regulatory document management.

Once implementation and training on the new electronic document management system concluded, the same tool and evaluative approach was applied to measure time and effort on the management of electronic based regulatory documents.

The analysed data yielded the following conclusions:

  • Manual maintenance of regulatory documents consume, on average, six and a half hours per study for one-time tasks, and seven and three quarters hours per study per month of a coordinator’s time for ongoing records management
  • Both one-time and continuous data management tasks are streamlined as an outcome of transitioning to an electronic system, resulting in approximately four hours saved per study for one-time tasks and over four hours a month for each study managed
  • The administrative burden required to manage regulatory documentation is minimised upon implementation of an electronic system, thus resulting in additional time a study coordinator can focus on increasing patient enrolment and subsequently study revenues
  • Remote login facilitates the sponsor’s monitoring process by providing access to review regulatory documentation via the internet

The specific time savings for a study coordinator associated with one-time tasks and monthly maintenance is demonstrated in Tables 1 and 2 respectively.


Setting the Ball in Motion

The lack of an electronic document management system results in sites spending a significant amount of time printing, filing, retrieving and storing study files to compliantly manage study records. Introducing a remote access, webbased solution provides the means to effectively store, access and manage the inordinate number of study documents. Adopting this type of solution has the capability to maintain an unlimited number of records in an organised and efficient manner, which in turn increases staff productivity and protocol compliance, all the while realising an overall cost savings for sites conducting research (3). The many benefits to all stakeholders through the adoption of an eDocument management solution include:

  • Patient safety and protocol compliance – improved protocol compliance through system versioning, which eliminates the use of outdated study protocol and consent documents
  • Economic – cost effective options available for eDocument management; time savings of electronic system maintenance may result in increased enrolment revenues for sites and meeting enrolment goals sooner for sponsors; minimises costs associated with paper consumption, printer toner, as well as printer wear and tear; and eliminates the need to contract off-site storage facilities
  • Space saving – reduces the need for dedicating space to store multiple regulatory binders
  • Increased performance efficiency – provides secure, remote, immediate access to documents; improved workflow for study coordinators by saving time on printing, retrieving, and filing study documents in binders as well as spending time with monitors retrieving multiple study binders for site visits; sponsors may elect to review regulatory documents from remote locations, therefore decreasing monitoring travel expenses

The first step to implementing an electronic document management system is for a site to create a team of stakeholders to evaluate the available software and select the one that best suits the organisational needs. Just as important is the focused implementation of the selected system. Ideally, implementation can occur in four steps and includes system structure design, establishing security settings, record transition and key user training. On average, the entire selection and implementation process will take five to eight weeks. Individuals included on the implementation team at a site may include the principal investigator, study coordinator(s), data manager(s), and information technology (IT) personnel. Figure 1 depicts a realistic timeline for system implementation.

Numerous electronic document management systems are on the market. When considering the best fit, sites should examine cost and capabilities of systems relating to the ease of structure development, growth capacity, user interface and system maintenance. A key feature of system maintenance that is attractive to many sites is the flexibility of hosting either on a server on site or through use of a secure, external farm. Many sites opt for the latter because of the reduced dependence on the internal IT resources. Other system features to be evaluated include system security, audit trails and versioning, and disaster recovery abilities.

Once a site has selected a system, the next phase entails system design and establishing security settings. The design consists of mapping the system and establishing sub-sites and directories. An important factor to consider during the design phase is system security levels specifi c to permissions and access limits to directories and folders, which will directly affect the structure of the directories during the mapping phase. The record transfer step starts with scanning existing hard copy study records for transition into electronic form and subsequent uploading into the appropriate system directory. To minimise document tampering, it is recommended that sites maintain and upload non-editable PDF fi le formats to the electronic document management system. The fi nal step of system implementation is training the key personnel on the proper use of the system.

It is imperative that sites take the time to create SOPs and guidelines related to the document management system that outline the purpose and intent, permissions and access policies, long term storage and disaster recovery. Current FDA regulations on long-term storage should be considered and incorporated to ensure SOPs are accurate and compliant. Trial sponsors are responsible for maintaining CFR 21 Part 11 compliance standards by retaining original regulatory documents, therefore sites conducting investigator initiated studies must comply with CFR 21 Part 11 by maintaining hard copies of all regulatory documents for these types of trials (5,6).


Streamlining project and data management processes in a manner that incorporates good clinical practice is an issue that research centres contend with on a daily basis. Added responsibility for CROs and sites has made it vital that existing processes be evaluated and revised for added efficiencies to minimise costs associated with conducting clinical trials. While great strides have been made to transition some areas of clinical trials from hard copy to electronic form, onsite regulatory document management is one facet that remains electronic-naive. The result is that sites, and consequently CROs, are burdened with additional costs, decreased personnel productivity due to an increased amount of sponsor required paperwork and retention times related to hard copy regulatory document management.

Sites choosing to implement an electronic document management system stand to reap multiple benefits by transitioning hard copy document management to electronic form, and including increased compliance, increased time devoted to enrolment, and minimised cost for document management and retention. Sponsors would gain the ability to perform electronic monitoring from internet abled locations and more coordinator time available for enrolment activities. Electronic document management creates transparency in trial oversight and builds a collaborative environment for sites and sponsors by facilitating userfriendly document sharing for review purposes. Employing an electronic document management solution opens the door to increased compliance, a shifted focus of staffi ng resources to enrolment and patient care all while ensuring that clinical trials conducted are done so in a manner that minimises financial burden.


  1. Clinical Research Value Case Work Group, Value Case for the Use of Electronic Health Records in Clinical Research: Processes to Support Core Research Data Element, ANSI Public Document Library, available at Clinical%20Research%20Value%20Case%20Extension.pdf, accessed 19 December, 2011
  2. JISC infoNet, HEI Records Management: Guidance on Managing Research Records, pp3-6, 16-22, 2007, available at www.jiscinfonet., accessed 20 December, 2011
  3. Belicher P, Electronic Health Records and Clinical Research, Pharma Focus Asia, available at research_development/electronic_health_records.htm, accessed 20 December 2011
  4. Sy RD, How to Best Develop Requirements for SharePoint Projects, Innovative-e, available at, accessed 26 February, 2011
  5. National Institute of Allergy and Infectious Diseases: DAIDS policy on storage and retention of clinical research records, April 2009, available at Documents/recordretention.pdf, accessed 13 December 2011
  6. Stamatiadis D, To e-Archiving and Beyond, International Clinical Trials November 2010, pp38-40, available at magazine/13/issue/142/article/2783

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Rhonda J Paz, PhD, is Senior Vice President, Clinical Research Operations at GuideStar Clinical Trials Management. She is responsible for strategising and implementing effective and effi cient operational units at clinical study sites. Previously she was the Associate Director for Scientifi c Administration of the Louisiana Cancer Research Consortium, where she established a centralised administration to oversee and manage scientifi c programmes, internal grant programmes, research informatics, as well as research core facilities. Prior to that, she served as the Director of Clinical Research and Human Protections Offi cer for the H Lee Moffi tt Cancer Center and the Medical University of South Carolina. Rhonda holds a PhD in Health Administration, a BA in Business Administration and Management, and is a Certifi ed Clinical Research Professional.

Diandra Nuno-Salcido is Site Operations Manager at GuideStar Clinical Trials Management. She manages staffi ng and daily operations of GuideStar’s research sites across the US. Diandra performs fi nancial analyses focused on clinical service and resource consumption for all trials and regulatory oversight to ensure sites meet industry guidelines for compliance. Prior to GuideStar, she held positions as lead coordinator in a variety of therapeutic areas, research coordinator educator and trainer, and regulatory compliance coordinator at Advances in Medicine and Children’s Hospital in Los Angeles, CA. Diandra holds a BSc in Biology and is a Certifi ed Clinical Research Professional.

Rhonda J Paz
Diandra Nuno-Salcido
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