With the SCRS Site Solutions Summit quickly approaching, we thought it might be helpful for sites who will be attending (and even those who are not attending!) to have a cheat sheet for the buzzwords surrounding eSource and CTMS -- buzzwords that will be everywhere at the conference! Read on for things you should know at the conference, and while investing in an eSource or CTMS system.
You'll be a master in no time.
Terms you should know when looking at eSource and CTMS:
Electronic source documents are the future of clinical research. But what exactly is eSource? Here is the FDA definition:
Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.
Ok, so eSource is a way for you to capture source data in electronic format. But what does this mean for your organization? eSource has the ability to eliminate 90% of the paper you use today, mitigate 50% of potential deviations, and save up to 32% more time. By going paperless you enable your site to to take advantage of the digital age: better quality data in less time. It is even preferred by the majority of CRAs!
CTMS, or Clinical Trial Management System, is a software system used to manage clinical research sites. CTMS often includes patient scheduling, patient recruiting, and finance management.
How can a good CTMS system impact your research trials? Think organization. CTMS software ensures that your site runs smoothly -- from easily making and reconciling invoices, to cultivating a patient database for 2x the recruiting power.
eRegulatory solutions are an electronic means of capturing documents traditionally filed in the "regulatory binder," or Investigator Site Files. eRegulatory can cover workflows such as the tracking of training and licensure expiration, or delegation of duties.
Part 11 Compliance:
Title 21 CFR Part 11 is part of the FDA's Code of Federal Regulations that governs electronic records and electronic signatures. Anyone who chooses to maintain records or submit information electronically are subject to Part 11. eSource and eRegulatory vendors must follow certain procedures to ensure that their system is compliant, which means being accepted as equivalent to paper records and handwritten signatures -- get familiar with it here.
Annex 11 is the European Union's version of Part 11-- read it here.
Electronic Signatures are covered under Part 11 Subpart C. Here, it states that eSignatures are the legally binding equivalent of traditional handwritten signatures, as long as certain conditions are met. This subpart is what allows PIs to work from home!
Voice Over IP (VOIP) is a technology that allows users to make voice calls or send text messages through the computer, instead of through a an analog phone line. VOIP is an important feature for sending subject text reminders or for calling prospective patients.
Lab or document routing is a term you might hear referring to how you can get all of your files (including labs, ECG tracings, medical records, etc.) into your eSource system. Document routing is helpful for ensuring that important files are easily accessible for PI oversight or annotation.
Electronic payments refer to patient stipends that are paid electronically through a stipend card. These cards are issued to individual subjects and can easily be filled up with a single click after the visit is completed.
Perk up if you hear someone talking about integrations! Integrated systems are your best bet for ensuring that your research studies run smoothly. Here is why integrations are important for your research site:
- Fewer logins
- Seamlessly move between data collection and site operations
- eSource integrated with Finance: every receivable is automatically captured when it is completed in the visit, never forget an invoiceable item again!
- eSource integrated with Recruitment: curate a patient database that is linked to source collection. Then, when the prospective patient is added into a study, all of their patient data is automatically brought over into their first visit.
What to look for when investing in a eSource and/or CTMS system:
Part 11 Compliance:
As stated, Part 11 is the governing body of eSource and eRegulatory solutions. It is what allows research sites to collect source data electronically. If your eSource vendor is not Part 11 compliant, you should not be using their system, as it could be a big issue if your site ever received a FDA audit. It is also a huge plus if your eSource vendor is GCP Compliant and HIPAA Compliant.
Bonus if they have evidence of third party validation!
It is important to note that while a vendor can be compliant, there is still documentation that must happen on "your end" to ensure full compliance. A good vendor will provide you with helpful tools and exercises to ensure that everything is squared away.
Integrations can make or break a eSource/CTMS system.
While adopting a new eSource and CTMS system does require a certain amount of initial effort, it should end up saving you time and money in the long term. If there are clear holes in the integration between the eSource and CTMS portion, such as items not being captured in Finances that are completed in the eSource, it may be worth considering a different vendor. The technology is out there-- there is no reason you should have to continue spending time on tasks that could be automated!
Ability to Customize:
Every clinical research organization is different, which is why it is important that the eSource/CTMS software is easily customizable to your unique workflows. Can you build the source that your site needs to capture adequate data? Is there room for flexibility when it comes to complicated budgets?
If you ever hear someone complaining about an eSource or CTMS system, it will most likely be because they aren't able to customize it to their needs. There is nothing worse than being confined to system workflows that make your day-to-day more strenuous.
Ease of Use:
An eSource/CTMS system may be robust and feature-rich, but if it is (unreasonably) difficult to use, it may not be worth the frustration. That being said, take the time to learn the system-- it will be an adjustment and will require effort.
However, if you feel that the burden of onboarding is not going to pay off in the long term, and your vendor is unsupportive during and after the process, it may be a sign to keep looking.
Adopting a new eSource/CTMS system is a change from your everyday operations. While this shift will pay off in the long-term, it does have an adoption learning curve as your team becomes familiar with the system and adopts the new workflows. Throughout this process, it is important that your vendor is present and responsive. You will have questions and you will (most likely) run into minor setbacks.
Your vendor should act as a partner-- your success is their success!
Clinical Research IO (CRIO) is a powerful, modern eSource, CTMS, and Stipend Solution built specifically for clinical research sites.
Come see us in action at Booth #111 at the 2018 Site Solutions Summit!
Anna Krauss is a Project Manager at Clinical Research IO. She has experience in the health field through her work as a Research Assistant with the MaineGeneral Hospital system, Hospital General de Agudos Bernardino Rivadavia in Argentina, and through her experiences working as an EMT.