Tag Archives: Medidata Rave

X EDC: The Next Generation of EDC?

RaveX is an EDC system that is powerful and easy to learn. Medidata has one of the best eLearning and training courses to get anyone up and running from the first time you use the system.

The study design setup still requires high technical skills including C# sharp for most complex data cleaning and study setup tasks.

Let’s discuss the new study hierarchy:

We already understand the relationship between the studies, sites, and subjects in Rave EDC.

At the navigation bar in RaveX EDC, we choose the study from the list of studies assigned to your role. At the second level, we can see the study dashboard. The dashboard contains information about the sites and subject enrollment.  From the sites, you can drill down to the subject level or subject related eCRFs.

Subject’s landing page:

  • Access eCRFs
  • Perform role-specific functions (e.g. SDV, DM data review, PI signature, enter data)

Understanding Status Icons in EDC:

On a form, when you click on an icon, the action is taken on that data point. Based on your roles and permissions, you could apply this action individually or to “Apply All”.

Common status icons:

When you select a subject, you arrive at the subject landing page. Some old features are the scheduled visit dates (a feel and look of the matrix in Rave Architect), the subject status and the status of their eCRFs and some additional information.

At the scheduled level (for Oracle InForm users, this is the Time and Event Scheduled with the traffic lights), you can open a folder and access a particular form residing on that folder.  You can then proceed with normal data entry.

There are several ways to access the same eCRF for another subject. Navigate to it by selecting a subject from the subject list.

Performing data cleaning and data review:

At the study level, select the RaveX study then select the study name you would like to perform a task.

On the screen, select ‘View Task Management’ link and then select the open queries link. At this level, you can select the particular subject and form a query that is opened on. For example, I noticed an open query on the informed consent form. To view it, select the query link on the screening informed consent row.

What modules are still available in this new design?

  • Rave Architect
  • Rave User Administration
  • Rave Site Administration
  • Rave Reporter
  • Rave Configuration
  • Rave PDF Generator
  • Rave Lab Administration
  • and more…

Overall, the EDC solution has been easy to use for database development, data entry, and data validation. The online, real-time validation feature is a plus as it does no longer requires the form to be saved for the checks to fire.

Have we lost any features to this new fancy design? Find out next.

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Advertisements

What Is In A Name Besides Letters?

Disclaimer: This is based on a fictional story in this fictional world.

Deciding on a name for your company or product is among the first steps an entrepreneur takes. Entrepreneurs often angst over the perfect name for their EDC tool. That name is a break or make deal for many. Your users will either identify with it or completely turn the other way and use your competitor’s EDC system.

It seems straightforward. Who wouldn’t want to stand out?

A rose by any other name is still a rose…

Let’s look at some Mythological names for several {EDC} systems.

  1. Medidata Rave: “Rave” at first thought, it is not an unique name. The traditional meaning of ‘Rave’ was to show signs of madness or delirium (rave. (n.d.). The American Heritage® Dictionary of Idioms by Christine Ammer) but most recent and contemporary meaning is ‘wild party’. For many of us, during the college years, we associated the word ‘Rave’ with underground parties, fun, entertainment and much more. I have been to several White Sensation parties here in Europe. Rave is my favorite name by far.
  2. Cmed Timaeus: Timaeus resonates with ‘Amadeus’. You know, the famous ‘Mozart’, Austrian composer, widely recognized as one of the greatest composers in the history of Western music. If you were born near the 80’s music era then this music video will come to mind.
  3. RDC: In contracts, RDC is “running down” clause, provides coverage for legal liability of either the shipper or the common carrier for claims arising out of collisions. Oracle RDC stands for ‘Remote data capture’. It is easy to remember and catchy.
  4. InForm: Is it ‘information forward’? Information in the form? InForm has been around for several years now. It started becoming popular in the 90s. There has been several modifications and upgrades but the name has stayed the same. It is now part of a group of systems own by Oracle.
  5. OpenClinica: I believe this name refers to the ‘open’ source capability of this tool. Open-source software (OSS) is computer software with its source code made available with a license in which the copyright holder provides the rights to study, change and distribute the software to anyone and for any purpose. (St. Laurent, Andrew M. (2008). Understanding Open Source and Free Software Licensing. O’Reilly Media. p. 4. ). I believe some users may confuse this name with Oracle Clinical, another popular CDM system.
  6. ClinCase: In computer science, CASE tools can be used for simple operations such as routine coding from an appropriately detailed design in a specific programming language, or for more complex tasks such as incorporating an expert system to enforce design rules and eliminate software defects and redundancies before the coding phase. (“CASE”. Encyclopædia Britannica. Encyclopædia Britannica Online). I personally has not used this tool but was asked recently so I added it to the fictious name list.
  7. RedCap: This is a catchy name as well. It can infer many meanings. Cap for capital letters, the cap or ceiling placed on mortgage rates, to protect or to seal? the hat that you wear, a member of the military police. Some further research, wikipedia has the following description of ‘redcap’: Redcaps are said to murder travellers who stray into their homes and dye their hats with their victims’ blood (from which they get their name) (Briggs, Katherine M. (1967). The Fairies in English Tradition and Literature. London: University of Chicago Press. p. 57) Regardless of definition, it is still a creative name.

You want a name that your employees and customers will want to say

Should You File For a Trademark? Here is some information about trademarks.

Having a brandable business name is one of the reason for the growth of business. Every EDC system is different and choosing the right name is key on getting the attention your {EDC} tool deserves.

One final reminder. When searching the list of fictitious names (also called “doing business as,” or DBAs) for your county and looking for names in your “class” (or industry) on the U.S. Patent and Trademark Office website (www.uspto.gov), be sure to look up variations on spellings, too, because names that sound alike can’t be registered in the same class. Also check Register.com to see which Internet domain names remain available.

what happens when you find out that your {EDC} name is also the name of another business in a different city/state? Keep it simple, as short as possible (check domain availability) and don’t play too much with spelling alternatives.

What is your favorite {EDC} name? Can a name make or break your chances of business success?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

 

Credit: The title of this article was an inspiration from a recent readingKate Of Gaia With Michael McCracken – What Is In A Name Besides Letters.” What an eye opening that was.

Fair Use Notice: This blog/article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

 

 

Open Source versus Commercial Systems

Types of EDC Systems: Commercial and Open Source

EDC systems can either be standalone databases on a desktop computer/server supporting a single site or they can be Web based with the ability to support multisite studies [1, 3, 27]. Based on the business model utilized and the licensing-distribution method followed, they can be broadly categorized as commercial and open-source EDC systems. Commercial EDC applications are usually developed by a for-profit company or developer group. They charge for user licenses with or without annual support contracts while the source code is not published. Some examples include Oracle® Clinical (Oracle, USA) [31], Clinsys® (Jubilant Organosys, USA) [6], InForm™ (Phase forward, USA) [22] DATATRAK Electronic Data Capture (DATATRAK, USA) [8]. On the other hand, free and open-source software are applications developed by a single or group of developers, often as a voluntary effort. The application and its source code are published online and users can download them without any cost. Some examples include DADOS P (Research on Research group, Duke University, USA) [7] OpenClinica® (Akaza Research, USA) [30], Redcap (Vanderbilt University, USA) [34] and TrialDB (Yale University, USA) [43] .

opensource_commercial

Commercial EDC Systems

Commercial EDC systems can either be purchased as a software package or through a license with periodic support either included in the package or charged separately. In some cases, users have to pay a one-time license fee while in other cases users can renew their license periodically. Troubleshooting and guidance are usually provided under support plans while bugs in the application are rectified and released under regular updates.

Commercial EDC applications are usually easy to use in light of the quality of documentation and customer support extended to users. Well-designed interfaces are responsible for their user-friendly design. Multiple levels of user access, security, adherence to industry and regulatory standards, support for the design of eCRF’s, data entry, and management are features common to many commercial EDC applications. Some of them may also be able to generate reports, for example, DATATRAK One™ (DATATRAK international Inc, USA) [8], Entrypoint Plus® (Phoenix Software International Inc, USA) [10], and CliniProteus (Roskamp Bioinformatics Core, USA) [5]. Although standalone EDC systems are prevalent, they are increasingly being offered as a part of a complete clinical trial management system (CTMS). For example Oracle Clinical and InForm are offered as a part of a larger CTMS.

Despite the benefits, commercial EDC systems are expensive [13] and frequently non-customizable. They have been considered inadequate in context to the needs of healthcare stakeholders (clinicians, administrators, and patients) [46]. Given the variety of clinical practices and research methods used, commercial EDC systems may not fit into the workflow at each clinical/research site, thus having implications on their effective and efficient use. Many of them do not support interoperable data standards, i.e. it may not be possible to merge data exported out of one EDC with data exported from another EDC system or research/clinical application. As a result data from multiple studies or sources cannot be merged and utilized for answering research questions. Since the source code is not released, users must depend on the developer group or vendor for customization and support-related requirements. This limitation is frequently referred to as “vendor lock-in,” which makes further development and maintenance of commercial EDC an expensive effort.

We reviewed the web to identify some of the prominent and popular commercial EDC systems. They include Oracle® Clinical, InForm™ and Rave® (Table 1). Among themselves they hold a larger share of the EDC market [3]. Other examples include DATATRAK and eTrials EDC (Merge Healthcare) [8, 11].

Oracle® Clinical [31] is a commercial EDC system for conduction of clinical studies and trials. It is a core component of an integrated eClinical research solution that integrates adverse event report reporting, thesaurus management, trial management and remote data capture features in a single application.

InForm™ [22] global trial management system delivers a variety of features essential for the effective and streamlined implementation of clinical studies and trials. It sports an impressive study setup page, scalability and has separate EDC and CDMS databases. Other features include an intuitive interface, streamlined workflow, reporting and analysis tools that help the study team to work more efficiently. It can also be seamlessly integrated with randomization, trial design, and medical coding modules.

The Rave® (Medidata solutions) [36] platform is another industry leader in EDC systems. It has an impressive study design tool that nullifies the need for programming skills. It offers a single, flexible and scalable platform that captures, manages and reports clinical research data. It also undertakes a balanced approach between ease of use, features and functionalities. It has the flexibility to interface with legacy systems, adheres to CDISC clinical data standards and sports a plugin for modifying the interface and functionality.

DATATRAK Electronic Data Capture has considerable market presence [8]. Its features range from patient data management, electronic forms, supports queries, alerts and visit scheduling and generation of custom reports. It is also equipped with custom checklists and workviews, configurable tools for data cleaning, real time statistical support and an integrated medical coding package.

eTrials EDC [11] is a web based application that collects, manages and analyzes clinical trial information in real time. It is a user-friendly yet robust application with an in-built workflow. It can generate reports and can easily integrate with data from other applications.

Despite being feature rich, scalable, secure and compliant to industry standards, these EDC systems are prohibitively expensive [13], thus limiting their use by individual investigators and users from developing countries that do not having adequate funding but are interested in research participation.

Open-source EDC Systems

Open and freely available source code released under open distribution licenses like general public license [14] is the defining feature in this category of EDC systems. Open source code generates a large community of users and developers that interact, modify, and enrich the source code over a period of time and report bugs and solutions, thereby enhancing the quality, features, and value of the EDC system. In order to sustain an open source license, developers usually charge for customization requests. The same is applicable to troubleshooting and support, which are usually delivered through a yearly contract or support plan. Thus, by providing free access to the source code and annulling restrictions on use, modification, and distribution, open-source EDC systems form an attractive alternative for users.

The availability of inexpensive (or free) open source EDC applications for individual physicians/researchers, departments, and institutes has the potential to improve clinical and research activities and enhance academic standards by reaching a wider audience. Since further development/customization and ownership costs are lower, institutional administrators can modify and adapt open-source EDC systems to suit their environment and workflow, thus ensuring the success of EDC implementation. User-friendly and simple interfaces, adherence to industry standard security protocols, customizability, interoperability, and low maintenance costs are some of the major benefits of open-source EDC systems. Additionally, the presence of user support groups and communities ensures continuing support.

Although open-source EDC systems have a unique mix of features, their adoption in healthcare organizations has been slow. Software cost and maintenance are not the only features that influence decision makers. For an institution/organization-wide implementation, decision makers usually prefer and opt for EDC systems that are easy to deploy, manage, and support. Not all open-source EDC systems qualify for the same. In addition, dependence on the developer community for support and updates may cripple the organization if the community stops being productive. It is possible to address this issue by hiring programmers who could work on further development and maintenance, But locating and training relevant workforce is a challenge as in many cases the background technology has a steep learning curve.

DADOS Prospective, OpenClinica® and Redcap are examples of open source EDC systems. DADOS Prospective is a Web-based application developed by the research on research group (RoR) [37] to support data collection activities among researchers, research groups, and research networks [7]. It enables users to replicate any case report form into an eCRF, collect data in single/multisite studies, and extract data in an interoperable format. It is compliant with Chapter 11, Title 21, Code of Federal Regulations [4] and Health Privacy and Accountability Act (HIPAA) guidelines for EDC. It can be used to streamline and support individual/departmental/institutional databases, registries, and single/multisite clinical/nonclinical studies and clinical at a low cost [28].

OpenClinica® [30] is an open source application that has both EDC and data management capabilities. As an EDC system, it not only facilitates collection, validation, and annotation of clinical data but also has features that allow study audits, reporting and data extraction.

Research electronic data capture—‘Redcap’ is an open source metadata driven application designed for the clinical and translational research target audience by Vanderbilt. Its features include: a streamlined process for building a database, an intuitive and secure data collection interface that supports data validation and automated data export in multiple formats. It also supports other advanced features such as branch logic and file upload. It is freely available to its consortium partners with a modest personnel investment of < 0.5 FTE that covers training and support activities [16, 34].

Source:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049639/

Articles from Clinical Orthopaedics and Related ResearcH
1Duke-NUS Graduate Medical School, Singapore, Singapore
2Research on Research Group, Duke University Medical Center, Durham, NC USA
3Department of Surgery, Duke University Medical Center, Box 3094, Durham, NC 27710 USA
4National Neuroscience Institute, Singapore, Singapore
Ricardo Pietrobon, Email: rpietro@duke.edu.
FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”.

In InForm, this is accomplished by using a tool called ‘User Management Tool’ or simple UMT. This tool allows sponsor to manage sites and users once the trial have gone live. There may be many different user groups with different levels and ranges of permissions.

Creating an InForm Trial – UMT:

  1. Create your InForm trial in the UMT. I won’t go into details on how to actually do this and depend upon the contract agreement with the vendor (i.e. Oracle/PhaseForward); they will perform this task for you.
  2. Select Trial Version = latest InForm version (i.e. 5.0)
  3. Select Countries where this trial will take place
  4. Select Status. Each InForm trial has 4 main statuses.
    1. Fast Start = Pre-Go Live
    2. Fast Forward = Trial is now live
    3. Fast Lock = Trial is lock
    4. Decommission = Trial is completed/archived

Managing users and groups can be a tedious task but tools such as UMT makes them easier to manage.

Roles: Roles (e.g. CRA, PI, System Administrator, etc) are used to assign specific permissions to individual users or groups, typically to perform specific functions in the InForm system.

The system allows you to either manually enter a role or import using a template called ‘MUL’ or Masters Users List. If you decided to upload your rights and roles via MUL, the system will generate a log file. It is imperative that you check this file and check any errors before proceeding.

Once the roles have been added to the UMT, you need to approved them before you build your clinical trial. The system also comes with defaulted and approved rights and roles.

Another option available is to create what is called as ‘signature groups’. If you are familiar with Medidata Rave system, this is equivalent to checking the ‘Signature required’ box and setting the investigator signature in Architect project main page.

Common use of Signatures in clinical trials are at the form level (i.e. 1 signature per form or at the subject level or studybook = 1 signature per subject).

Item Groups: Items groups is used to overrides or restrict a particular user access to a form or field. This is equivalent to ‘Restrictions – View/Entry’ in Medidata Rave.

One good example of display override usage is the coding fields restrictions. If only Clinical Coders are allowed to view / entry data on those items, you will limit access to all roles but the coders role.

Here’s a snippet of the code in .XML:

<!–?xml version=”1.0″?>–>
<MEDMLDATA xmlns=”PhaseForward-MedML-Inform4″>
/*some other code goes here*/
<ITEMGROUP
GROUPNAME=”Hidden Coding Items”
GROUPDESCRIPTION=”Hidden Coding Items”>
<!– Insert ItemRef Names –>
<ITEMREF REFNAME=”PT_NAME”/>
<ITEMREF REFNAME=”HLGT_NAME”/>
<ITEMREF REFNAME=”HLT_NAME”/>
<ITEMREF REFNAME=”LLT_NAME”/>
<ITEMREF REFNAME=”SOC_NAME”/>
</ITEMGROUP>
</MEDMLDATA>

Two other important groups that you need to be aware of is the Query and the Report Groups. The former, as the name entails, allows a user to open, answer, reissue and close queries during the course of a clinical trial. The latter, allows a particular user to run reports.

For example, an Ad Hoc User can access Ad Hoc reports via Cognos. The roles associated to this group could be your project manager, Clinical Research Associate (CRA) or your Lead Data Manager (LDM/CDM).

Once you have completed your basic setup, you will need to prepare or cook those xmls files onto your clinical trial. The rights/roles we discussed needs to be in an approved status. You also want to make sure you ‘lock for QC’ or lock the trial to prevent anyone from making changes to already added sites/users.

Sites and Users marked for upload to InForm will automatically be cooked into your trial.

Last step we need to take is to generate the XML files by selecting the link ‘Generate InFormXML.’ Now, your UAT trial is created, your URL is set up and you are ready to perform User Acceptance Testing.

Remember to validate your XML files, especially if your clinical trial is running across several countries. I have found issues with foreign languages symbols or special characters entered in the UMT system. Avoid at all cost any special characters.

Source: User Management Tool Reference Guide from PhaseFoward

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.