Tag Archives: Electronic case report form

Hashgraph: Electronic Data Capture Future?

Hashgraph technology, created by Leemon Baird, it is probably going to replace blockchain technology.

Since the introduction of bitcoin there have been many thousands of blockchain based crypto currencies created and there are more being created every single day so what’s different about hashgraph?

Well it isn’t a blockchain it’s totally different in fact the way it works is a real Mindbender and a bit difficult to explain.

Instead of a block in a blockchain hash graph calls their packages of information “events”. Your computer takes a transaction like a payment or anything else for that matter such an action in the eCRF form (e.g. SDV) you want to record and puts it in the event for transmitting information quickly hash graph uses a technology that has been the gold standards in computer science for decades. Its super fast and its called ‘gossip protocol’. Your computer randomly tells another computer in the network about the even you’ve created and that computer responds by telling your computer any events it heard about then that computer tells another computer about your event and the other events it heard about and the computer its talking to responds by telling all the events its knows about. Its absolutely the best most efficient way to spread information and it’s exponentially fast  And the best part, it also includes the information of the time it heard it and who it heard it from and the time they heard it and who they heard it from and so on and it is called ‘gossip about gossip’ and it lets everyone knows what everyone else knows and exactly when they knew it and just fractions of a second.

Another key feature is ‘virtual voting’. Even though an old technology, it was slow but with hash graph, there is no voting instead because everyone already knows what everyone else knows you can mathematically calculate with 100% certainty how they would vote and allows hash graph to come to consensus almost instantly so instead of recording things on a block and adding it to the block chain once every 10 minutes hash graph events are added to the system instantly the moment they are created so they don’t have 10 minutes worth of information in them. That means they are small and contain far less data so they use very little bandwidth and are much easier to transmit and uses a minuscule amount of power which makes it fast, fair and more secure than block chain.

All events are time-stamped the moment they are woven into the system so the record of whose event came first and whose came second is instant and there is no such thing as soft forking or unconfirmed events.

It can also replace huge portions of the internet that are currently run by centralized servers by replacing them with the shared computing power of all of our own computers, iPads and cell phones.

It looks like hash graph might have all the potentials  of fulfilling all the original hopes and dreams of a true Electronic Data Capture system (e.g. eCRF forms collected at site, ePRO/eCOA data directly from subjects, external or local lab or ECG data from any lab, eSAEs, Inform consents, and more). In other words, sites, sponsors, labs, regulatory and all vendors working seamless with each other.

Imagine an investigator or research site completing an ‘event’ (e.g. Enrolled or randomized) and the system automatically sent the payment to the site at the end of each event.

The power to decentralize and remove the middleman with the speed at which technology is evolving the future is looking bright.

One of the challenges of any new technology is how do you really explain to people how do you make a compelling case for what makes a technology so compelling and one of the things that is so compelling about this technology is throughput – the speed.

You are probably thinking but what about eSignatures? Or Informed Consents? or Regulations? There is another technology ‘smart contracts‘ that could lead to substantial improvements in compliance, cost-efficiency and accountability.

What is a  Smart contracts? are contracts whose terms are recorded in a computer language instead of legal language. Smart contracts can be automatically executed by a computing system, such as a suitable distributed ledger system. The potential benefits of smart contracts include low contracting, enforcement, and compliance costs; consequently it becomes economically viable to form contracts over numerous low-value transactions. The potential risks include a reliance on the computing system that executes the contract. [Distributed Ledger Technology: beyond block chain, UK Government Office for Science, 2006]

Smart contracts

Bitcoin technology uses a tremendous amount of energy to run the system and also it is scaled up it became slower and slower to where it was no longer a currency it was basically a speculative vehicle you could make some gains in purchasing power. A transaction with bitcoin technology can take 4 hours for confirmation.  With hashgraph, compared to Bitcoin, uses no power.

If Bitcoin were to replace the entire world monetary system and financial markets, it would use more power than the entire world produces. It’s completely unsustainable.

Hashgraph, smart contracts, distributed ledgers and similar technologies offer new ways to share information, reduce errors, and it is cost effective to all users. Perhaps a new Electronic Data Capture system for clinical research will emerge.

Source:

Hashgraph.com

The Crypto Revolution

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Choosing a Successful Clinical Trial Management System [CTMS]

Steps towards a successful CTMS:

Exploring the benefits of clinical trial management system (CTMS)

The benefits of mapping and developing an enterprise wide solution include6:

  • Centralizing decentralized departments
  • Optimizing institutional review board (IRB) functionality
  • Realizing real-time data available to both investigators and leadership
  • Decreasing bottlenecks in knowledge transfer between various entities involved in research
  • Reducing human errors in reporting that often cause compliance issues
  • Tracking milestones for grants, awards, fellowships, etc.
  • Streamlining the financial structure — billing and invoicing

operational, infrastructure, compliance, and governance issues that can be improved by implementing a CTMS:

  • Staffing: with a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.
  • Communication: improved communication will improve patient satisfaction and monitoring of clinical trials.
  • Human error: CTMSs have integrated checking components to limit errors in reporting.
  • Operational flow: improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.
  • Managing clinical data: more accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

 

Choosing a CTMS that serves your institutional needs

ctmsEven though there is no perfect system, consider the reviewing of some common elements among most of the best systems:

  • Financial reporting tools (coverage analysis, residual and overage reporting)
  • Clinical trial management tools (including applicable clinical trial milestones and reporting dashboards)
  • Searchable clinical trial database
  • Analytical risk-based decisions
  • Reporting dashboards
  • Data warehousing module
  • Recruitment support module
  • Electronic case report form (eCRF)
  • Integrates easily with electronic medical records (EMRs), IRB system(s), etc.

Cost factors and implementation overview

In our experience with the implementation of CTMSs, the following are key aspects of the process:

  • Building a steering committee: the most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.
  • Forecasting future issues: know the current and future issues of the institution that hope to be resolved with the CTMS.
  • Adapting to change: understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.
  • Training and preparation: design an ongoing tailored training program to meet the short- and long-term needs of staff.  Implement training and train staff on the new technology.

A successful CTMS connects all aspects of clinical trial management and allow administration to focus on making strategic decisions based on analytics and accurate real-time data.

References: Original article can be seen at Applied Clinical Trials with

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

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