EPRO Clinical Solutions – Data Management & IT


clinical trial sponsors can collect patient reported results electronically multinational clinical trials. Benefits include significant improvements in clinic and content compliance, data quality, data access and monitoring, as well as lower personnel and material burden. Yet EPRO clinical solutions can also present challenges. By understanding a few important EPRO best practice, however, the sponsor can overcome major challenges

EPRO Clinical Solutions. A brief summary of the challenges

One of the main problems faced by use of medical records of results (EPRO) in international studies is to ensure the quality and reliability of EPRO system and data files. After all, even a small problem with the system or data can sometimes damage the credibility, which can lead to reduced use of the system, increased enrollment, inquiries, and other charges, trial, and at worst, the discrediting of all data.

Another challenge is the very large number of changing variables that must be controlled. These parameters are:

– Complex protocols and long questionnaires

– Long lists of countries, language and translation

– Complex system requirements

– interactive boats

– Long a growing list of issues

– A number of first days of patients

-. International customer service across different time zones in multiple languages ​​

value, or measurement equivalent validated paper questionnaires can also be a significant challenge. Because of the nature of the hardware and software, some systems can not fully support the current validated paper questionnaire.

For example, a small hand-held devices generally have very limited screen real estate. IVR systems are limited because people can only remember brief questions and answers. In these and other cases, questions and answers from the validated paper questionnaire often be changed in order to accommodate the technology.

In order to ensure then that data from electronic systems equivalent to paper-based questionnaire, it is often necessary to conduct a validation study comparing the data collected on new electronic tool with data collected on the validated paper questionnaire. These studies validating or can add significantly to both cost and project time lines.

Finally, the challenge faced by many when the medical records of the results of international studies, quality assurance and audit. Some auditors have little experience or knowledge of EPRO system, leading to a broad interpretation of the rules the industry. These rules varied interpretations can cause confusion, and also have some cost and timeline effects

EPRO Clinical Solutions :. Best Practices

The challenges described above may seem difficult for the research team, even though they appreciate the chance. However, there are solutions. Best practices outlined offer a method to manage the challenges

EPRO Clinical Solutions. SYSTEM quality and reliability

All successful systems start with an unambiguous system requirements document. The purpose of this document is to describe the system (s) to be delivered in detail, so that all team members have exactly the same expectations of what the system will do and what data the system will provide.

The process of writing and reviewing detailed planning document, whether it is the system requirements, a research clinical or otherwise, forces the author and critic thinking about options for the process to discuss and tweak them until there is confidence among all participants that the best solution has been designed.

So the system requirements definition process, properly executed, produces quality thinking on system design and is the first step towards producing a quality system. In addition, because the hand writing a detailed document that describes how the system will work, preventing the misunderstandings, confusion and frustration later when using.

A system requirements document shall include all screen shots exactly as they will look at the complete system. Any change for each data entry field, screen and system validation tests and logic (Skips, conditions, calculations, error conditions, messages, and so on) must be described clearly and in detail.

This documented the introduction of the system both “on the surface” and “under the surface” (logic control, and so on) enables sponsors team and EPRO hand to think about things carefully before programming begins. It will also ensure that the system design ensures compliance with the protocol and the resulting data will meet the needs of the study.

Final system requirements document must be signed by the main sponsors and EPRO hand the men to show agreement and commitment of both parties about the details of all system functions and operations. When evaluating companies, the sponsor should ask to see the system requirements documents from previous projects.

The sponsor shall ensure that providers have the ability to deliver reflective ready system requirements document that describes the quality system with characteristics sponsor desires :. ease of use, protocol compliance, data quality control, fast data access, and so on

To consistently delivers reliable system, Electronic Patient results provider will also have the ability to develop and implement quality system test plans. Test plans must include thoughtful test cases to take all the necessary system requirements document.

To ensure all systems need is covered, it will be a traceability matrix with every requirement in system requirements document to the relevant test cases in the test plan. This may seem obvious, but it is often not done.

For each system requirement will also be detailed test cases and scenarios for both valid and invalid data, as well as standard and non-standard user actions. Expected results for each test must also be documented in advance of the test cases to ensure the reliability of the test. In addition, the test plan should contain a large input data sets that represent a variety of different situations.

Furthermore, it is important to test plan are significant strain and stress testing to ensure that the system will function properly in real world conditions, when an unusually large set of data has been collected or when stressful situations are up.

When performing the test plan, test analysts will have to prove whether a move adequately and ensure that all data files is correct, without exception. In assessing EPRO providers, the sponsor should also review test plans and traceability matrices from previous projects to ensure that the provider has the ability to develop and execute test plans that meet the standards described above.

In addition to the formal testing performed by hand, the sponsor must also carefully software by performing user acceptance testing. The purpose of this test is to ensure that both EPRO team and sponsor of the team agree that all system requirements have been described in

system requirements document.

If there is executed a good test plan, the sponsor of the process should be fast and easy, and should provide the sponsor team final control and peace of mind before performing system for the first patient date. However, if there has not performed sufficient testing, quality revealed and sponsors the opportunity to delay shipment and require corrective action before the system is distributed to sites and become a burden on the field.


Because there are so many moving parts in international studies, it is important that the provider can develop and maintain complex project estimates. Verkefnaáà | plans must contain hundreds, sometimes thousands, detailed tasks and expected durations, dependencies between them, and the reaction surprises.

Because EPRO project schedule usually includes hundreds of projects, which gives the show skills with electronic project management tool thus changing the environment can be accommodated quickly. The assessment provides a process, donors should also look at the project schedule and project reports from previous studies to determine the project management skills providers.

In addition, good communication among project team members have to be the rule and not the exception. Regularly scheduled project meetings with key personnel from both the sponsor and provider are important to review the status of project tasks, whether changes are necessary, and resolve any issues that arise. This post project meetings are important to ensure that the sponsor and member of EPRO efforts support and effective

EPRO CLINICAL SOLUTIONS :. CHOOSE systems that significantly reduce validation issues

To solve the challenge of measurement equivalent validated paper questionnaire and electronic equipment, sponsors can choose the technology that certified paper questionnaire text does not change. Touchscreen tablet or Internet-based systems typically offer this kind of flexibility

Although it is beyond the scope of this article, the validation requirements for this technology are minimal

EPRO Clinical solutions .. Manage Quality assurance auditors

Given that many accountants have little experience of the medical records of the results, sometimes their statements can be confusing and even frightening.

If the auditor made demands seem unreasonable, it is important to review the regulation (s) the auditor and find more practical solutions. In most cases, there are various ways to ensure regulatory compliance, and many of them are simple and cost-effective


best practices discussed above can provide real tools to deal with challenges that may arise in the implementation of health information reported

criteria in multinational clinical trials. While these best practices do not cover every possible situation that may occur, they will provide significant assistance in addressing key challenges and put clinical trials of a solid path to success.


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