An Introduction to Electronic Data Capture Software. Learn the basics to find the right system for your needs

Transcription

1 An Introduction to Electronic Data Capture Software Learn the basics to find the right system for your needs By

2 Forte Research Systems Software to fit your clinical research needs Cloud-based clinical trial management system that manages the operational data for small to mid-sized sites. Click here to learn more Comprehensive clinical research management system for mid-sized to large organizations with complex needs. Click here to learn more Electronic data capture system for sponsors and CROs that fully supports compliance with 21 CFR Part 11. Click here to learn more A collaborative community of research sites that are committed to excellence in clinical research operations. Click here to learn more 2

3 Introduction Clinical research is becoming more complex, and those involved in the conduct of clinical trials need to do more in less time. Besides staying on budget, it s essential to maintain compliance and accurate records. To keep up with these demands, many research organizations are realizing the advantages of electronic data capture (EDC) and are leveraging new technologies to support clinical trials. Learning a new system can certainly be an adjustment and may seem like an additional challenge in itself. However, choosing the right system can end up saving significant time and increase the overall efficiency of clinical trials. If you re new to EDC systems, this ebook will provide an overview of EDC, examine how it can address several challenges you may face, and list questions to ask when evaluating vendors. 3

4 Chapter 1:...5 Overview of EDC Table of Contents Chapter 2:...11 Challenges Addressed by an EDC System Chapter 3:...16 Choosing the Right EDC System 4

5 Chapter 1: Overview of EDC This chapter defines what an EDC system is and how specialized systems can be beneficial to your organization. This high-level overview will help you learn the basics by covering common functionality that is found in most systems. 5

6 Chapter 1: Overview of EDC What is an EDC system? To put it simply, an EDC system is web-based software that stores patient data collected in clinical trials. Data is typically first recorded on paper source documents before being transcribed into the system, and saved in an electronic case report form (ecrf). More and more sponsors and CROs are choosing EDC software as a preferred tool for managing clinical trial data. A few years ago we may have said, EDC is the way of the future, but now it s the standard. EDC systems have been used to carry out both simple and complex trials in all phases of research. 6

7 Chapter 1: Overview of EDC What is commonly found in an EDC system? Not all EDC systems are created equal, and not every solution will fulfill the needs of every organization. Most EDC systems offer slightly different features, but in general EDC software is designed to streamline data collection and review. Many vendors are continually developing new software enhancements to keep up with changes in the industry. While the bells and whistles vary from system to system, there is some common functionality that you ll find in just about every EDC system. Common functionality: Hosted Role-based user permissions ecrf designer Data entry Query management Audit trail Data export 7

8 Chapter 1: Overview of EDC common features Hosted Solution Many EDC systems are cloud-hosted with data entry done on a web-based interface. Being in the cloud means easy access from anywhere with a browser and connection to the internet. Given the nature of the data collected, software vendors need to make sure the data is safely stored, protected, and backed up. Role-Based User Permissions Secure access to data is extremely important, especially with concerns for patient confidentiality and data integrity. Within an EDC system, each user account has a unique username, password, and designated permissions. This limits what each person can see and defines the actions they can perform within the system. 8

9 Chapter 1: Overview of EDC common features ecrf Designer When creating ecrfs, there are design options to choose from that are meant to imitate paper forms. Forms are saved in a library, eliminating the need to recreate commonly used forms. When building ecrfs, edit checks can be programmed to help prevent data entry errors. Data Entry After a protocol is set up in the system, data is entered into the appropriate forms. Real-time checks on data are performed as data is entered into the system, based on the edit checks that were programmed into forms. 9

10 Chapter 1: Overview of EDC common features Query Management An EDC system provides streamlined communication between monitors, data managers, and coordinators. Most systems have auto-generated queries, as a result of programmed edit checks, and the ability to manually add queries. All queries need to be responded to and resolved before the data can be locked. Audit Trail An EDC system that fully supports validation and compliance with 21 CFR Part 11 must have the appropriate technical controls in place. One of these requirements includes an audit trail that tracks a form s history. This includes who made a change, the date and time a change was made, the old and new values entered, and the reason the change was made. Data Export Once data is ready to be pulled out of the system, there are easily accessible exports. Additionally, some systems have built-in metrics reporting that offer insight into the progress of a study. 10

11 Chapter 2: Challenges Addressed by an EDC System Making the switch to an EDC system can help solve some common challenges associated with other methods of data capture such as: Efficiently managing time spent on data collection and review Ensuring compliance Minimizing data entry errors Finding what you need, when you need it 11

12 Chapter 2: Challenges Addressed by an EDC System Efficiently managing time spent on data collection and review Everyone involved in clinical research understands the importance of saving time and the need to do more with fewer resources. With paper trials, double data entry is time consuming. An EDC system can save a significant amount of time by reducing inefficiencies and facilitating better communication. Forms are created, data is entered, queries are resolved, and data is locked all in one system. The sooner database lock occurs at the end of a study, the quicker the availability of the data for analysis. The time saving benefits of EDC can be recognized once users are trained on a system. 12

13 Chapter 2: Challenges Addressed by an EDC System Ensuring Compliance It is critical that clinical research is conducted in compliance with FDA regulations and in accordance with Good Clinical Practice. Some organizations may use spreadsheets to collect and store clinical data, assuming it can take the place of a more sophisticated database. However, they are risking noncompliance with industry standards and regulatory requirements. Without restrictions, data can be manipulated or altered in a manner that s nearly impossible to detect. An EDC system must support compliance with regulatory requirements, specifically 21 CFR Part 11. An EDC system is not validated out of the box, as it requires your organization to develop processes around your use of the system. However, the system must have the appropriate technical controls in place for those who plan to submit clinical data to the FDA. An EDC system has audit trail functionality, in which every change made to data is tracked. Electronic signatures require a unique username and password to log in and perform certain actions. This secure access for authorized users helps ensure that the integrity of the data collected is not compromised. To complete the validation process, you have to start with a validation ready system. 13

14 Chapter 2: Challenges Addressed by an EDC System Minimizing Data Entry Errors Have there been times when you had trouble reading the handwriting on paper CRFs, or discovered unnecessary, irrelevant, or omitted data? If you ve used spreadsheets, have you wondered if errors have gone unnoticed? Not only do these methods leave room for poor data quality, they also cause monitors and data managers to spend too much time checking for errors when they could be focusing on more complex review tasks. EDC reduces the chance of data errors caused by illegible writing on paper CRFs. While there is still potential for transcription errors for people using paper source documents, the review by monitors and data managers looking at the data on screen rather than two hand-written copies reduces the likelihood of poor writing being a factor. Less paper also means less risk of misplacing or damaging the CRFs that contain critical data. It s possible to eliminate inconsistencies across studies and other factors that jeopardize the quality of data by using standardized forms in an EDC system. Programming edit checks helps prevent invalid data from being entered into ecrfs, which fire upon data entry for automated review. This results in fewer errors and helps enforce data quality and completeness. 14

15 Chapter 2: Challenges Addressed by an EDC System Finding what you need, when you need it Do you know exactly where to find all your forms? Are they stored in different places? Can you access them immediately? If it takes too long to locate forms due to having to sift through large volumes of paper, being uncertain of which file contains the most up-to-date version, or not being in close physical proximity of them you re stuck in an inefficient process. With EDC software, forms are safely stored and backed up in a cloud-hosted system. This allows authorized users to remotely access a fully searchable central location from anywhere. With a library of standard forms, it s easy to reuse them across multiple protocols. This also takes the guesswork out of identifying which is the newest version if you need to make a change to a form. An EDC system offers organization with flexible navigation, providing greater visibility, while using less paper. 15

16 Chapter 3: Choosing the right EDC system Finding an EDC system for your organization is a big responsibility and can be a daunting task especially when you don t know where to start. How do you begin to sort through all the choices and find the right solution? As with any smart purchase, you need to do some homework before making a decision. Here are some questions to ask to help identify the right EDC system and vendor. 16

17 Chapter 3: Choosing the right EDC system What features are necessary? This may seem obvious, but when selecting an EDC system it is important to make sure the software provides the right functionality to help achieve your studies goals. Since not every system is the same, it s important to be able to identify which features are essential. If you need a simple solution, you don t want to be stuck paying for features you don t need. Realizing the differences between needs and wants can save a lot of money and help your bottom line. 17

18 Chapter 3: Choosing the right EDC system Is the system easy to use? An EDC system that s easy to use should be easy for all users. Overall usability involves looking at every role within the system. Choosing a solution that has an intuitive design and flexible navigation will make learning and using the system simple. This is especially helpful when making the transition from traditional methods of data capture to EDC. Instead of being stuck with a system that s too difficult to use, be sure to schedule a demo prior to making a decision to see if the system is as user-friendly as it s presented to be. 18

19 Chapter 3: Choosing the right EDC system Are you planning on submitting your data to the FDA? If the answer to this question is yes, you need to know if the system fully supports validation and compliance with 21 CFR Part 11. Compliance is a twoway street, but has the vendor done their part? Has the system been audited by a third-party and verified as compliant? Relying on a vendor s interpretation of the regulatory requirements can result in the risk of noncompliance for your organization. 19

20 Chapter 3: Choosing the right EDC system How long does implementation take? Consider the timeline of the entire EDC selection and implementation process, and how that relates to your studies timeframes. Depending on your deadlines (anticipated purchase date, study startup, etc.) some systems may be out of the question. How much of a learning curve will there be? Some EDC systems take substantial time to learn, while others are so intuitive that only a few hours of training is required. Is there software to install that has to be managed by your IT department? Ask the vendor if they need to approve actions or perform additional steps that could result in delays for you. 20

21 Chapter 3: Choosing the right EDC system What is offered for training and support? Does the core study staff receive training? How much training is required before you can start building studies? When you need assistance is there ongoing support offered or immediate help in the system? If customer service is a top priority, the product support team should welcome customers questions, comments, and feedback. Check to see if the vendor includes both customer and technical support with the cost of the software or if they charge extra fees. 21

22 Chapter 3: Choosing the right EDC system How does the vendor prioritize new features? Many EDC systems are continually evolving with regular software releases. Will feedback from you and other members of the user community be included in new versions of the software? Do they collaborate and strive to create successful vendor-client relationships? If that s the case, their planned enhancements should continually evolve and improve the software, as well as align with your future needs. 22

23 Chapter 3: Choosing the right EDC system What is your budget? One major barrier to EDC adoption is funding. Purchasing a system can seem like a large investment, but it should save money in the long run. Since staying within budget is crucial, it s important to choose a system that makes sense for your studies, whether that s a pay-as you-go license or a one-size-fits-all contract. Are things like hosting, training, and support included in a subscription? If your study changes, how are you charged for things like additional sites? Know the total cost of the system, and make sure there is a clear understanding ofwhich expenses are and are not included. 23

24 Chapter 3: Choosing the right EDC system What is the vendor s history? Part of choosing the right system is also choosing the right vendor. It s important to enter into a relationship with a partner that will be there for you now and into the future. How long has the company been in business? Do they offer other products? Are they growing? Have they won any awards? Looking at a vendor s past performance and stability can help you judge if the company is going to be there for you in the long run. 24

25 Conclusion As drug and device innovations continue to develop, so do software solutions that help enhance and accelerate clinical research. Adopting an EDC system has many benefits. Not only can it help meet regulatory compliance and improve data quality, but it can also save time on tasks that are traditionally inefficient. It s important to do your research and consider factors beyond functionality to select the right solution for your needs. With the right system and vendor, making the transition to EDC will be easier than you think. To learn more about the specialized systems provided by Forte Research Systems, please visit Contact Us Forte offers additional educational resources to help you pursue clinical research excellence. View our additional resources today! Additional Resources 25

26 Resources Forte Research Systems (2014). 5 Problems With Using Spreadsheets to Collect Clinical Data. Retrieved from com/news/5-problems-using-spreadsheets-collect-clinical-data. Forte Research Systems (2013). Advantages of EDC Over Other Methods for Data Capture. Retrieved from news/advantages-of-edc-over-other-methods-for-data-capture. Forte Research Systems (2014). Choosing an EDC: 8 Questions to Ask When Evaluating Vendors. Retrieved from com/news/choosing-edc-8-questions-ask-evaluating-vendors. Forte Research Systems (2014). The Beginner s Guide to an Electronic Data Capture (EDC) System. Retrieved from forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system. Forte Research Systems (2014). Why It s Time to Make the Switch from Paper to EDC. Retrieved from time-make-switch-paper-edc. 26

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