Each tracking system will have their own levels of regulatory compliance for trial and sample data. LabKey Sample Manager offers CFR Part 11, HIPAA and FISMA compliant software and cloud hosting , used by leading life science organizations and the FDA.

Not only does Sample Manager create audit-ready logs for all sample events, we have a unique Sample Timeline that allows users to easily browse a sample-centric chain of custody for auditing and troubleshooting.

Can you customize fields and add built-in validation to ensure correct data entry? Look at each product you are considering for built in validation. Sample Manager allows administrators to add validators to both numeric and text fields to ensure correct data entry.

Depending on the product you choose, you can find reporting options that work for you. Some trial sample tracking systems may have limited functionality. For more robust systems, look for an API to connect to, allowing you to create custom reports in the software your lab prefers.

LabKey has built-in reporting and charting tools to quickly assess the data, as well as many advanced tools such as built in R and SQL reporting, integrations with Tableau, Spotfire, etc. Can I capture participant clinical trial data within the same tool to centralize my data? If you choose the right clinical sample tracking tool, you can centralize your data easily.

LabKey has an extensive study module that integrates with our clinical sample tracking system that allows teams to capture all clinical data. We integrate with REDCap and Medidata RAVE as well.

Our study publishing capabilities allow teams to share information with collaborators in a secure way including date-shifted and de-identified data.

Want to learn more about our clinical sample solutions? This trial is notable not only because it is televised, but also because it includes testimony from many in-person witnesses and several others via videoconference.

Of those participating remotely, some testified live and the testimony of others was pre-recorded. Trials will occur in brick-and-mortar courtrooms moving forward, and technology will facilitate in-person proceedings just as it does virtual ones. This continued unpredictability means that courts will need to embrace flexibility to remain operable no matter the circumstances.

After my most recent column covering court reporting tools was published, an email arrived from a reader of this column who wondered if I had any recommendations about tools to facilitate the in-person trial presentation of exhibits.

This includes ensuring you understand how that company will handle the data; where the servers that will store the data are located; who will have access to the data; and how and when it will be backed up, among other things.

These tools are designed for use on iPads only. Each app has its own trial function and offers unique ways to present your case to the finder of fact. The apps cannot be purchased separately. With DocReviewPad, you can annotate, review and produce documents.

TranscriptPad allows you to import deposition transcripts from a number of different sources, including many typical cloud providers and AirDrop. Once imported, you can read, annotate and search transcripts. TrialPad is designed for trial presentation. You can organize, annotate and present trial evidence via an intuitive and easy-to-use interface using this app.

Once files are imported from major cloud providers, AirDrop and more can be displayed using VGA or HDMI-compatible projectors. As is the case with most trial presentation software programs, you can call out certain sections of documents, zoom in and out and much more.

Next is ExhibitView Solutions. This company offers a number of trial preparation tools as well as both premises-based and cloud options. ExhibitView Trial Presenter is a premises-based trial presentation software tool that is compatible with PCs only. It also integrates with ExhibitView via Dropbox, which means you can prepare for trial using ExhibitView and then present at trial using iTrial.

TranscriptPro is another PC-compatible software tool that supports video deposition editing and facilitates digital transcript review. Exhibit Presenter is another PC-based trial presentation tool.

With this software, you can share and manipulate PDF exhibits in court as you present your case. There is a free demo version available as well. Right now, this software is available only to beta testers and pricing is not available.

Let's start with four companion products from Lit Software that facilitate trial preparation and presentation: TrialPad, TranscriptPad Missing The Hospital Inpatient Free Trial Program (HIFTP) provides UZEDY to eligible inpatient hospitals that cannot accept Prescription Drug Marketing Act

Sample trial programs - Clinical sample tracking helps research teams know where samples are in the receiving, storage, testing and analysis process Let's start with four companion products from Lit Software that facilitate trial preparation and presentation: TrialPad, TranscriptPad Missing The Hospital Inpatient Free Trial Program (HIFTP) provides UZEDY to eligible inpatient hospitals that cannot accept Prescription Drug Marketing Act

This template has been developed by the NIAMS to assist the PI and the study team with the writing of a DSMP and details the elements to be included such as Study Overview, Participant Safety, Reportable Events, Interim Analysis and Stopping Rules, Data and Safety Monitoring, and Data Management, Quality Control and Quality Assurance.

The DSMP is required for all clinical trials. The NIAMS may require a DSMP for clinical research e. More information about the requirement for a DSMP are found in the NIAMS DSM Guidelines. See the complete template for How to Write a Data and Safety Monitoring Plan DSMP.

These are templates developed for investigators, data managers, study statisticians and others involved in submitting periodic reports to the NIAMS-appointed, independent monitoring bodies e.

The proposed structure can be customized according to the individual study needs. The NIAMS templates can serve as a starting point for developing study specific reports but the NIAMS does not require they be followed. Open Data Report Aggregate Template.

Closed Data Report by Unmasked Group Template. Enrollment Report. Milestone Enrollment Graph. The site addition request form must be completed by the study team and submitted to the NIAMS for review when requesting the addition of a new site to an ongoing clinical trial.

Site Addition Request Form. NIAMS Clinical Research Operations and Management Branch Division of Extramural Activities DEA Democracy Blvd. Suite Bethesda, MD Phone: Arthritis and Rheumatic Diseases. Current Funding Opportunities.

NIAMS Labs and Core Facilities. For Principal Investigators. For Patients. All NIAMS News. Director's Page. Bone Health. Facebook Email Print. Facebook Email. Users can share visualizations with specific team members or an entire group. Yet, data security filters prevent unauthorized access to either data or visualizations.

SAS JMP Clinical and J-Review are examples of clinical research targeted software that enable graph enhancement. These tools have functionalities that allow you to interact, animate, and drill down into the data.

Laboratory testing in clinical trials presents many challenges regarding sample collection, management, analysis, and interpretation. Luckily, technology has advanced and digital sample and data management processes have been applied to improve multiple laboratory aspects of clinical trials.

Connecting all stakeholders through a shared understanding of integrated data optimizes processes, reduces clinical trial life cycle, and minimizes costs.

Morgana Moretti, PhD Morgana Moretti, PhD. View Full Profile Learn about our Editorial Policies. Published: Feb 22, Register for free to listen to this article.

Listen with Speechify. PDF Version. Top Image: Improved sample and data management is becoming easier to accomplish with technological advances and modern digital data management processes. Clinical Laboratory Solutions for Decentralized Clinical Trials.

Decentralized Clinical Trials Are Here to Stay. To further reduce data entry, the sample management application you choose should also allow information to be imported or synced from other systems such as Electronic Data Capture EDC , Laboratory Information Systems LIS , and Clinical Trial Management Systems CTMS.

To support these integrations, care should be taken to build a common vocabulary and data structure so that data is recorded in a consistent manner. Regardless of the challenges you may face in implementing a sample management solution, there are a couple ways you can streamline your sample inventory needs.

Often, the easiest strategy to adopt is creating a virtual sample repository for the items collected in your individual trial or program. A virtual repository compiles sample information received from each of your sites and labs and merges it together into a single database.

This can be done with a file import or through web service integration. The advantage of this type of system is that each site can continue to use their preferred data collection method.

However, because data is collected in various formats, work will be required to ensure the data is consistent, and there may be holes in the sample custody or data received from the site. The preferred option would be to implement a transactional system that records the sample information at each stage of the lifecycle, resulting in a full picture of how a sample was collected, processed, and transferred.

The system may also include storage management allowing you to not only know which site or lab is in possession of the sample, but also where it is located in the building, and how many times it has been in and out of the freezer.

Whether or not your organization will choose to implement a new system or improve on the one currently in place, my hope is that the clinical research community will continue to invest in more streamlined and efficient sample management processes.

After all, every research sample is extremely valuable - but only if you can find it first. Get more clinical research insight with our FREE newsletter sign me up.

Log In or Subscribe. Guest Column November 9, Tracking Clinical Trial Samples: What Can Go Wrong Will. By Claire Anderson, clinical research specialist, Sampleminded Early in my career, I accepted a position as a specimen tracking coordinator.

Is Sample Management Really That Important?

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