Page 7 – Advarra

At Advarra, we strive to provide sponsors, contract research organizations (CROs), and sites with the knowledge they need to perform adequate quality management as they work to advance safer, smarter, and faster research. Similarly, the Society of Quality Assurance (SQA)’s mission statement indicates the organization aims to “Promote and advance the ethics, principles, and knowledge of quality assurance essential to human, animal, and environmental health.”

Last month, at SQA’s annual meeting, Advarra’s VP of Research Services and Strategic Consulting, James Riddle presented Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance. In his presentation, Riddle outlined how sponsors should consider 21 CFR Part 11 (Part 11) compliance at research sites and how that fits in with the overall quality management system they may administer, build, audit, or evaluate.

As the research industry is continually evolving and adapting, many institutions, health systems, and private research sites are adopting more electronic technologies to streamline operations. While oftentimes, sponsors or CROs provide sites with validated technology, many adopt these technologies themselves. For quality management professionals and site regulatory personnel in the position to evaluate a system’s effectiveness, quality, and compliance, they need to understand how Part 11 compliance fits into the quality management framework.

Understanding Compliance

According to the Food & Drug Administration (FDA), “Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.” Essentially, if a research site owns, controls, or operates its own systems with electronic FDA-regulated records, Part 11 applies. This is applicable for electronic records such as:

Signed consent forms
Source documentation
Institutional review board (IRB) records
Drug accountability logs
Delegation of authority logs
Other records required to be kept by the site per FDA regulation

As Sponsors/CROs evaluate sites, it’s important to inquire if there are computer systems in use at the site which store FDA-regulated records in an electronic format, as these will need to be evaluated to determine if the system housing those records has been validated per FDA guidelines. Validation is about objective evidence, consistency, and documentation of the processes put in place. Quality managers or individuals with an understanding of the Part 11 requirements need to make sure the site has appropriately validated any computer systems they’re controlling relative to Part 11 if they store FDA-regulated records within the system. For example, an eRegulatory binder system would apply to this situation because FDA-regulated records are stored electronically. A site’s accounting system, on the other hand, has financial data and would not be subject to Part 11.

To ensure compliance and validation, a site needs to have processes in place to provide objective evidence that they are using and providing good documentation of their records and that they have controls in place that do not allow unauthorized changes to the documentation. Sites must be able to produce evidence that their electronic records can be trusted in the same way as paper records.

Sponsors have utilized validated computer systems for decades and typically have well-established programs based on GAMP 5 with core documentation including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documents and system development life cycle methods. Individual research sites may be less familiar with validation concepts and need some support from the quality management program or the software vendors to establish the necessary validation documentation.

What is risk-based validation?

According to Pharma Manufacturing, risk-based validation is “a validation philosophy in which qualification and validation processes are streamlined by an honest assessment of risks to product quality posed by an equipment feature, process step, or process capability.”

When coming up with their assessment of risk for systems, sites must be able to justify their definition of risk. Advarra advises most research sites to evaluate their computer systems in the context of risk to human health. For instance, the software used by a device manufacturer to run an implantable pacemaker is high risk. If the software does not work as designed the impact on human health can be immediate and severe. On the other hand, a site’s regulatory document management system storing electronic records such as consent forms, delegation logs, etc. has a low risk to human health if the system fails. Very similar to the concepts behind Risk-Based Monitoring; computer systems determined to be lower risk can have a less stringent level of validation testing as long as the level of testing is commensurate with the risk as outlined in the site’s risk-based validation SOPs.

Considerations for sites

If a site is collecting, maintaining, or storing essential records in electronic format, it is imperative to maintain Part 11 and validation statuses. Taking an inventory to see where these records are can help the site understand what systems may need to be validated. If sites are using electronic signatures on any of their essential records, Part 11 signature requirements also apply. Sites also need to remember to submit a certificate of intent to use electronic signatures to the FDA.

Additionally, if sites are using commercial, off-the-shelf software, they need to have procedures in place to ensure they are relying on software vendors who are able to attest their computer system complies with Part 11 and is built with computer validation processes in place. This is even easier with software as a service-based (SaaS) vendors, where there are no on-premises servers or other equipment for the site to install and validate in a hardware environment. For private research sites, it’s recommended to rely on a software vendor only if they have attestation about Part 11 – and most vendors will provide attestation.

Before site-level systems subject to Part 11 are set in place, sites need to implement a basic set of standard operating procedures (SOPs). These documentations need to outline policies or procedures on how sites are complying with validation and may include:

Policy on Part 11 Compliance and computer system validation
Conducting system inventories
Validation planning, testing, and summary documentation for covered systems
Conducting vendor assessments
Training and quality assurance
Business continuity plan

Sites can keep the records locally for systems they are maintaining and controlling, as well as the attestation from their vendor. Having this documentation ready for an FDA inspector, and more importantly, a quality manager will help keep research operations smooth and efficient.

A study opportunity is presented to your organization. How quickly and confidently could you take on the study? This is the concept of research readiness. Research readiness, when put into practice, ensures that your organization can accept, activate, and adapt to new studies and opportunities no matter the regulatory circumstances, be it decentralized structure, protocol complexity, or even a global pandemic.

To be research ready, your organization must have:

Visibility for all stakeholders into a central repository to keep regulatory processes moving
- Can your leadership team, whether on-site or remote, oversee study progress and identify bottlenecks?
- Are you able to support monitoring in-person and remotely?
- If you’re coordinating a multi-site study, do you have visibility and connection to their operations and required documents?
- Can you communicate with external stakeholders like monitors, sponsors, and IRBs quickly and compliantly?
Systems that communicate effectively and compliantly
- If you’re working within multiple technology systems, do they minimize duplicate data entry and support more efficient routing and storage of documents and signatures?
- Is each system appropriately 21 CFR Part 11 validated or secured for its intended use, regardless of in-person or remote workflows?
- Do you have a mobile-friendly signature process for investigators?
Easily accessible, documented, and scalable processes for research conduct
- Have you established compliant and optimized standard operating procedures (SOPs)?
- Where are your standard operating procedures stored? Are they accessible to all necessary staff?
Up-to-date training materials and systems to recognize training completion
- How do you manage and track staff training on study procedures and processes?
- How is training certification or acknowledgment routed to required locations?
- Once trained, how quickly and accurately can tasks be delegated across your portfolio?

No other system supports research readiness like an eRegulatory Management System. An eRegulatory management system can centralize your training, documentation, processes, and communication needed to efficiently and compliantly activate a trial. In collaboration with leading academic research institutions and cancer centers, Advarra eRegulatory Management System (eReg) has evolved to comprehensively support and ensure research readiness.

This past year has displayed firsthand that the definition and expectations of research readiness can change dramatically. When COVID-19 hit, many organizations found themselves without the necessary processes and infrastructure to conduct research or accept new studies, hurting their research goals and delaying activation timelines. That’s why we’re ensuring Advarra eReg is not only research ready today, but also built for the future.

Immediate Document Access from Anywhere

Access, route, store, and centralize staff credentials, standard operating procedures (SOPs), organization documents, and past performance documents to streamline regulatory workflows from any site location.

Integrated Processes

Leverage integrations with key regulatory systems within Advarra eReg including eIRB and local IRBs, OnCore Clinical Trial Management System (CTMS), and email correspondence to increase compliance and efficiency.

Community-Driven Workflows

Benefit from innovations by regulatory teams like yours. Utilize standardized workflows developed with community in mind including regulatory templates, digest notifications, and controlled and secured monitor access.

A Future-Proof eRegulatory System

Maintaining a research ready state requires a successful foundation for an ever-evolving industry. Advarra eRegulatory Management System is preparing for the future of clinical trials by expanding our solution to serve across the entire stakeholder spectrum, from sponsors to sites. We’re working closely with our customer community to maintain site-centricity as we expand integrations both inside and outside the Advarra ecosystem including connections with eConsent tools, OnCore CTMS documents, sponsor platforms, and more.

To explore recently released features in Advarra eReg and discuss how we’re building an eRegulatory management system that supports research readiness in the future, attend our Advarra eReg Open Demo.

The past year has been one of the most challenging ever for those working in healthcare and clinical research. The industry faces unprecedented obstacles as we navigated the dual challenge of developing a COVID-19 vaccine. At the same time, also keep research moving forward in other areas. As we begin to emerge from the pandemic, we see that the research landscape has fundamentally changed. The past year has shifted the focus of sponsors, CROs, and research sites to improve in critical areas, including:

Access to research for diverse and underserved communities
Education of the general public on the efficacy and safety of new treatments
Standardization of data and process across the industry
Adoption of enterprise technology

While some focus areas above are long-term challenges requiring joint effort across the industry, technology adoption can be a quick win for organizations looking to improve processes, cut costs, and adapt to remote workflows. At Advarra’s recent 2021 Spring Onsemble Conference, a longtime customer lamented his organization’s lack of an effective eRegulatory (eReg) solution as his team faced the pandemic. “We desperately need an electronic document management system,” he said. “There are things that we haven’t been able to do as efficiently or effectively as we needed to, and that’s something we need to address quickly.” His organization is not alone. As your site looks to address this fundamental need moving forward, here are four ways an eReg system can increase productivity, improve compliance, and ensure a solid return on your technology investment.

4 Ways an eReg System Ensures Regulatory Success

1. Enterprise Integrations

Staff productivity and data quality are critical priorities for any regulatory team. By integrating your eReg solution with enterprise technology such as your eIRB system, clinical trial management system, emails (and corresponding attachments), and even other eReg systems, you can ensure a more efficient and compliant trial.

Learn more: Utilizing eRegulatory Integrations to Expedite Regulatory Workflows

2. Remote Capabilities

With research staff forced to work from home and on-site monitoring halted, remote regulatory workflows have quickly become a necessity. As a centralized hub for regulatory documents and activities, a full-featured eReg system can be a vital resource to keep your team on track and provide visibility into the regulatory components of a trial. It can also facilitate remote monitoring by safely and securely granting access to monitors. A system such as Advarra eReg allows monitors to view only the essential documents they need to see on a site visit and only during the time specified by your site.

3. Master Delegation of Authority Workflows

For institutions managing a large volume of trials, a master delegation of authority can be a great solution to streamline the study activation process and minimize the burden on regulatory teams. However, standardizing staff delegation across multiple studies can be challenging without technology to manage the delegation process and electronic signatures. An eReg management system can help your organization manage an electronic master delegation of authority log, simplifying the delegation process and dramatically reducing the amount of time spent routing documents.

4. 21 CFR Part 11-compliant Routing, Signatures, and Document Management

At the foundation of any eReg management system is the management of your essential protocol documents. The ability to store protocol documents, efficiently route them for electronic signature, as well as track owners and expiration dates are critical components of an eReg solution.

The Advarra eRegulatory Management System provides all of the functionality above and has been developed through years of collaboration with dozens of leading academic medical centers, cancer centers, and health systems. This means it not only helps your institution become more efficient and compliant, but it also leverages the expertise of top organizations to help you build successful, centralized, and sustainable regulatory processes across all your trials.

To learn more about Advarra eReg, attend our two-part open demo series. Our first demo will focus on how eReg provides a comprehensive solution to boost productivity and compliance, taking a deep dive into many of the areas above. In the following demo, our team will discuss the future of eRegulatory management. Highlights will include:

Upcoming eReg functionality enabling additional remote workflows
Integrating across your technology ecosystem
Further centralizing your regulatory management and much more.

Engaging participants and creating a positive experience throughout your clinical trial increases protocol compliance, participant retention, and future recruitment and referrals. It may seem difficult for large, international, multicenter trials to ensure a positive experience for each individual participant. However, organizations can succeed despite the distance, language, and trial complexity by focusing on three key aspects of engagement identified by participants:

Keeping participants informed
Ensuring they’re part of the team
Conducting smooth and seamless site visits

Strategy #1: Keeping Participants Informed

Participants want to feel completely up to speed and informed about their trials. To support comprehension and inclusion, how and what you communicate should incorporate your participant group’s unique needs. This includes consideration for diverse age ranges, ethnicities, and levels of health literacy. You should also consider participant preferences when it comes to communications, information-seeking behaviors, and what messages are most likely to resonate.

This may seem difficult to put into practice, but in reality, all you need are a few simple steps. Establishing a dialogue with your target population early on, delivering consistent communication throughout the trial, and seeking feedback from participants about their experience go a long way. In addition, extend engagement beyond the trial itself by informing participants of the potential trial outcomes.

Strategy #2: Making Participants Feel Part of the Team

Research shows there are highly significant benefits to feeling like you are part of a team working toward a common goal.¹ Tactics to harness team energy include generating buy-in for each team member’s role and responsibilities, communicating what the trial aims to achieve, and reiterating the importance of each team member’s active participation. To implement these strategies successfully, your organization must engage with and depend on the site.

Strategy #3: Establishing Smooth and Seamless Site Visits

To ensure site visits are smooth and seamless for participants, you need to first understand considerations influencing their experience. Ask the following:

Have you prepared participants for what procedures to expect during each visit?
Are participants aware of the time commitment of each visit?
Where can they access this information, and is it up to date?

For example, your site may need to conduct a procedure rendering the participant unable to operate a vehicle for a certain amount of time. Does your participant understand they will need to arrange appropriate transportation after the visit? To communicate expectations, utilize intuitive platforms like Longboat to guide your participants before, during, and after their visit.

As mentioned, engaged sites are critical to successfully engaging participants. It’s equally important to understand what factors affect the site team, as it is ultimately the participant’s interaction with site staff most significantly impacting the visit. A good trial experience relies on sponsors and CROs focusing on what really matters to both sites and patients. This means looking for ways to reduce site burden, allowing them to focus attention on participant engagement and care.

The Role of Trust in Engagement Strategies

The key to overall success is establishing trust between participants and trial staff. Each side needs to understand, acknowledge, and respect what is important to the other.

Participants are the single most important part of clinical research. To succeed, commit to giving the information and resources they need to be informed, empowered, and appreciated. Proven to increase retention and comprehension, the Longboat Platform supports and engages sites and participants. To learn how, reach out for a demo today.

Source:

https://news.stanford.edu/pr/2014/pr-motivation-walton-carr-091514.html

Over the course of seven weeks, Advarra conducted an anonymous survey to collect site-specific study activation data. This data covers a wide range of topics associated with clinical trial activation and startup. Topics include IRB/IBC, regulatory and compliance, and Medicare coverage analysis, to name a few. For the purpose of this blog, we analyzed the information associated with financial feasibility and budget negotiations.

It is important for sites to identify all potential costs associated with a clinical trial. This is needed to confirm all time and effort is accounted for and reimbursed by the clinical trial’s sponsor. Without the budget developed to show all research costs, sites risk unidentified or “hidden” costs going unaccounted for.

Additionally, the significance of obtaining reimbursement for these costs is even more vital. Research sites and sponsors continue to negotiate rates and payment terms, forever altering the definition of “fair market value.” Not only should sites obtain reimbursement for all applicable costs, but they should also do so in a timely manner to streamline their study activation process.

Advarra conducts budget development and negotiation tailored specifically to an institution’s guidelines and research rates. Learn more about how to streamline the budget development and negotiation process through Advarra’s Budget Negotiation Service.

Startup

Within the study activation survey, we asked sites how much they request for their study startup fees. This includes other one-time startup fees, such as the pharmacy startup, but exclusive of ongoing expenses, such as serious adverse event (SAE) reports or closeout costs. When asked how much a site would request in startup costs per the study, we found:

43% request under $10,000

29% request $10,000 to $15,000

6% request over $25,000

A piece of information believed to heavily influence startup rates was the disease setting of the clinical study. Early and late phase drug studies tend to yield higher startup costs. Settings like observational, behavioral, and device trials often have a lower startup rate in comparison. When comparing the site’s startup costs to the disease settings they participate in, sites participating in a higher percentage of early/late phase drug trials frequently have higher startup rates. However, these sites continued to request under $15,000 in total startup costs.

Demographics

Due to extensive regulatory processes, academic medical centers (AMCs) and universities typically take longer to develop and negotiate clinical trial budgets. Their private counterparts, such as health system-based sites and independent research centers, are more flexible in comparison. Nevertheless, we wanted to determine if these associations are true.

There was little to no difference in startup costs between AMCs and non-AMCs; yet, AMCs take notably longer to negotiate their budgets. AMCs most commonly reported their budgets take over 90 days to negotiate, while their non-AMC counterparts most commonly take between 30-90 days.

Turnarounds

Initially, we predicted the higher a site’s startup cost was, the longer negotiations would take. This is because of the back-and-forth needed between the site and sponsor to negotiate this high startup rate. However, our results did not support this theory. When comparing the turnaround timeline of budget negotiations to the site’s requested startup rate, our most common responses were:

<30 Days: Sites with the lowest startup costs (<$10,000)

30-90 Days: Sites with the highest startup costs ($15,000+)

90+ Days: Sites with the lowest startup costs (<$10,000)

The most notable takeaway is the split difference in answers from sites with the lowest startup costs (<$10,000). While many of these sites can reach an agreement in under a month, most sites taking 90+ days to negotiate a budget also are those requesting under $10,000 in startup costs.

One reason for this bell-shaped curve result is simply due to having a turnaround time goal. Of sites that complete negotiations between 30-60 days, 68% have a standard turnaround timeline goal with budget negotiations. On the other hand, only 45% of sites who complete negotiations in 90+ days stated they also have a standard goal turnaround timeline. Having a standard goal or deadline on budget negotiation timelines may result in more efficient processes without sacrificing funding expectations.

Challenges

When asked about internal pain points associated with budget development and negotiations, the top response was the number of available staffing. The second most common result was staff expertise, and the third was staff turnover. Building and then negotiating a clinical trial budget requires knowledge of both the site’s clinical and financial operations. Each institution operates in its own specific way, making the budget process that much more of a challenge.

Why do negotiations take so long?

In understanding why budget negotiations take so long, sites pointed to sponsor response times and negotiating the budget costs. These budget costs were itemized between startup, per patient, and other ongoing administrative costs, but respondents indicated all three selections were problematic when negotiating. Sponsor response time was a popular response as well, with many sites pointing out the budget review sits in the sponsor’s queue for an extended period of time.

Respondents also wrote in their answers for this question, more so than in other budget-related questions. Frequent responses included challenges surrounding new COVID requirements, internal staffing and turnover, and internal communications with the clinical team and/or a health system’s central office.

Conclusion

Obtaining site funding in a timely manner is critical to the success of a clinical trial. It is important for sites to calculate all costs associated with clinical trial participation, and to relay this information to the sponsor. While sponsor response times and the art of negotiating certain costs add to the study activation timeline, sites need to have specific timeline goals to ensure the success of their budget negotiations.

Download the Study Activation Industry Report

To better understand study activation roadblocks, Advarra asked sites to weigh in on their study activation experiences. Our latest industry report outlines these findings, providing sponsors and site suggestions and solutions, equipping them with information necessary to streamline and improve the overall study activation process. Access the Report

At the core of daily regulatory operations are the documents required to facilitate, manage, and provide a record of the conduct of a research study. Historically reliant on paper binders, manual and redundant workflows, and burdensome monitor visits, many sites are seeking ways to streamline source document management. In the past few years, sites have increasingly turned to electronic systems to support remote workflows and keep their research moving. Facilitating remote monitoring across a site’s research portfolio is quickly becoming an expectation. To respond to these site needs, we have collaborated with our customer community to develop new workflows within our Advarra eRegulatory Management System. Continuing to transform the way essential protocol documents are routed and stored, we’ve introduced the capability to store and manage additional key study documents; subject binders and standard operating procedures (SOPs).

Store and Manage Subject Source Documents

Source documents associated with each study participant need to be stored by the research site and accessible to the sponsor for source document verification. These documents include signed consent forms, contact information, compensation records, and more. For every protocol binder, there are numerous additional subject binders to support each subject and their source documents related to the protocol, which dramatically increase your document storage needs. Ensuring proper storage of source documents is essential to the compliance and validity of your trial. Any source data captured on a paper document or in a system that does not allow controlled remote access, whether it is a signed consent form, patient diary, notes, and more can be scanned and uploaded into Advarra eReg for compliant storage and managed access for source document verification.

When you centralize your subject binders with Advarra eReg, the need to transport subject binders to multiple locations to be monitored is removed. Multiply that by the number of subjects you’re supporting across your research portfolio—the time, effort, and money you save grows exponentially.

Centralize and Retrieve SOP Documents

Not only are the processes outlined in your organization’s SOPs essential to execute in a consistent manner across your institution and participating sites, the controls in place that ensure appropriate study conduct and compliance also need to be communicated to external stakeholders. By centralizing your SOP management, you can quickly access SOP documents for internal staff and grant access to sponsor monitors, helping to bolster your organization’s audit readiness and enabling timely retrieval of any requested document.

Expand Remote Monitoring

It’s important to remember in this digital age, electronic workflows don’t automatically equate to remote capabilities. Unlike web-based systems such as SharePoint or Box, the intuitive, purpose-built workflows within Advarra eReg go beyond simply storing electronic versions of essential protocol documents, subject source documents, and SOP documents. Instead, eReg transforms the storage, upload, routing, signing, and verifying of your regulatory documents. Utilizing these workflows, your organization can efficiently and compliantly drive a complete remote monitoring process.

For example, Advarra eReg’s remote monitoring workflow supports easy access via a secure login link for the sponsor, as well full control over what the sponsor monitor can see and the timeframe for access. To increase transparency between your organization and the sponsor, you’ll also have the opportunity to view when the sponsor monitor logged into the application and what they downloaded for review.

Ensuring Scalability to Adapt to the Future of Research

Remote workflows and regulatory efficiencies will continue to be a priority and opportunity for research sites. Go beyond the binder and support your entire regulatory document management within a centralized, expanded eRegulatory system. To explore simple and efficient remote monitoring workflows, tour new storage capabilities and more, request an Advarra eReg Demo for your team.

Billing compliance is one of the most important and complicated processes researchers deal with on a day-to-day basis. The consequences of inaccurate billing can be severe, and ensuring workflows are being followed by all teams across an institution can be a difficult process.

More than a dozen individuals and groups can be involved in clinical research billing, and communication is key to ensuring billing procedures are being followed from start to finish. When communication breaks down or processes aren’t followed, it can leave the institution (as well as key individuals) at risk. For example, these breakdowns can include billing a trial participant’s insurance for items paid for by sponsors or accidentally billing for services that are promised free during the consent process. Other risks could include billing for services that only pertain to the research itself or billing for non-covered services during a non-qualifying trial.

Taking steps toward compliance

One way to overcome these challenges is to implement a clinical trial management system (CTMS) that centralizes billing information to help ensure accuracy. Combined with solid billing compliance processes, these systems help alleviate many of the concerns regarding communication and standardization across teams. Enterprise software like Advarra’s OnCore Enterprise Research System allow staff to build a coverage analysis, which is a protocol-specific billing list of items and services provided as part of the trial. The billing summaries (also called billing grids) mirror the protocol calendar and provide documentation of billing decisions, including an assessment of routine costs and why the study is believed to be qualifying. These are valuable tools, and an important step toward compliant billing.

In addition to ensuring charges are routed accurately, using a coverage analysis can bring further benefits to your research organization. For example, the ability to reference a clear list of what items are and aren’t billable early in the study startup process can be valuable when building your budget and negotiating with sponsors. The coverage analysis can also be used by compliance officers to monitor and audit the ongoing compliance of trials.

Increasing compliance with integrations

If you’ve already implemented a CTMS, another step towards billing compliance is integration with your electronic medical record (EMR) system. For example, OnCore is able to send complex study billing definitions to an EMR system through the IHE Clinical Research Process Content (CRPC) profile. This means all applicable team members involved in the research and/or billing process can leverage the same billing designations. If a patient is also a subject enrolled on a study, that status will be visible to the organization’s billing office, ensuring charges are routed properly and potential billing issues are avoided.

Want to learn more?

If you’d like to learn best practices for compliant billing and see how a clinical trial management system (CTMS) can help centralize your billing designation, register for our webinar Facilitating Compliant Billing Using the OnCore Enterprise Research System. We’ll demonstrate specific billing workflows within OnCore and discuss how integrating OnCore with your EMR can help your organization build a successful clinical research billing program.

Reporting and operations knowledge plays an important role in successful research conduct, from communicating with leadership and funding entities to informing decisions around study startup, protocol selection, and staff assignments. Having confident visibility into your research operations and resources has continued to grow as a priority for leadership across the country, evidenced by the increasing reliance on reporting and analytics teams.

However, the reporting landscape is wider than ever, ranging from ad hoc reporting off internal data warehouses to deployment of fully-fledged business intelligence solutions like Tableau or Power BI. Choosing the appropriate combination of methods, tools, and teams to derive meaningful, actionable information from your research data requires intentional planning for the highest return on investment. Here’s why thinking about reporting staff and tools as ‘either/or’ limits your organization’s potential.

The Shared Value of Standardization & Collaboration

Advarra Insights was created to address common challenges faced by research organizations across the industry. While operational hurdles and OnCore workflows may feel unique to your institution, our experience and collaboration with research teams revealed many common topics that could be addressed effectively through a standardized business intelligence solution. Advarra Insights contains turnkey dashboards that provide actionable insight into managing study activation, accruals, effort tracking, and more, which have been fine tuned to the shared reporting needs we see across the community.

Learn how UW Carbone Cancer Center benefited from Advarra Insights’ collaborative development to improve their site accrual

Maximize the Impact of In-House Reporting Teams

Consider this – when your reporting team is being inundated with requests and has limited bandwidth, what is the best use of their time? Comprehensive dashboards from Advarra Insights acts as your institution’s core suite of reports, providing teams with a collection of out-of-the-box analytics reports covering accrual, activation, and financials. By leveraging the effort already invested by our developers and community collaborators in Advarra Insights’ core reports, your custom reporting teams are unleashed and can refocus their effort on high value, high impact institutional reporting tailored to your unique datasets and inputs. This maximizes their time and expands the scope of work they can deliver.

For example, perhaps your institution has an initiative to improve and expand service to underserved populations. A way to maximize resource allocation is to leverage Insights’ Accrual Demographics dashboard to analyze and segment accruals by gender, race, and pediatric status. With those segments covered, in-house teams can focus on examining other accrual variables like rural vs urban that may rely on additional, institution-specific data sets available to your organization, like an EHR database. Leveraging both resources – the out-of-the-box reporting suite in Insights and in-house reporting teams – enables your institution to have a more robust, efficient view of underserved population accrual to then develop data-driven strategies for improvement.

Be Free of Behind-the-Scenes Burdens

When report writers use time to manage data gaps or fix errors on core reports, it detracts from the time spent on deeper, more institution-centric reporting. Advarra Insights ensures accurate, consistent, and up-to-date dashboards so you can efficiently and confidently provide insight to your organizational leadership and study teams. In addition, Advarra Insights aligns with OnCore’s security to more easily and securely share reports across your organization without worry of appropriate permissions or access. Rounded out with comprehensive documentation and secure hosting, you’ll be able to trust and quickly utilize the information available at your fingertips.

Leveraging standardization, maximizing your custom report capabilities, and removing behind-the-scenes burdens are all ways Advarra Insights can complement your current full-time reporting staff. Explore more about Advarra Insights to advance your research potential.

Finding new ways to more accurately and efficiently manage the regulatory compliance process is always a hot topic among researchers. Over the past four years, I’ve been working with Advarra customers to collaborate on the strategy and development of an eRegulatory system that addresses these needs. One thing has become clear: managing protocol documents using physical binders or an internal shared drive can put a research site in a difficult position, reducing productivity and regulatory compliance. Below are a few reasons to consider an eRegulatory system.

Centralizing your regulatory processes

Whether your regulatory department has a central body, or if you have separate regulatory offices per department, getting everyone to speak the same language and manage essential documents in the same system pays dividends in efficiency and compliance. As PI’s move from one protocol to another, or when staff change departments, having all regulatory information gathered in a standardized format will improve study start up and reduce the need for duplicate document management.

Ditching the paper and the manual document routing process

An eRegulatory system can help you avoid tracking down study staff members and PI’s by foot. It manages the legwork, notifying staff members when they need to sign and review essential documents. And by electronically signing documents and tracking them within the system, you save valuable staff time while maintaining 21 CFR Part 11 compliance.

Utilizing a single source of truth for staff credentials, training and more

An eRegulatory system eliminates the need to search the shared drive for the PI’s medical license or the protocol coordinator’s curriculum vitae across multiple protocols. The system can connect staff members to their protocols, and update credentials and training for staff members in one location and share them across all of the applicable protocols. You can also gain visibility of expiration dates for protocol documents. An eRegulatory system can run reports on expiration dates for 30/60/90 day intervals over multiple protocols, providing staff with valuable insight and allowing them to better manage their workload.

Easily preparing your site for monitor visits

Grant access to monitors to the essential documents they need to see on a site visit. You no longer need to find the binder and set it out for the monitor to ensure they are able to view the documents needed. An eRegulatory system ensures that all documentation is easily managed, all in the same user-friendly format.

What to expect from an eRegulatory system

eRegulatory systems are more than an electronic version of a paper binder. These systems go beyond the binder, strategically designed to improve cumbersome regulatory workflows, communicate with other electronic systems used by your organization, and increase compliance and remote capabilities. Did you know an eRegulatory system can:

not only store essential protocol documents but track owners, training, expiration dates and easily route for signatures?
manage multi-site trials, allowing a coordinating center to manage essential documents for participating sites?
integrate with other electronic systems like email, CTMS, or eIRBs?
manage delegation of authority workflows, including master delegation of authority?
securely allow remote access to sponsors and monitors?

By utilizing an eRegulatory system with purpose-built workflows to support your regulatory teams, you can reduce staff workload, increase regulatory oversight, and enhance compliance. If your organization is looking to improve regulatory efficiency, learn more about Advarra’s eRegulatory system or request a demo.

More than ever, recent medical advancements encourage and allow hospitals and clinics to work together, adopting technology to streamline their operations. Finding the right software to fit an organization’s needs may require looking at multiple options available.

Recently, Advarra’s Staff Augmentation team worked with a customer’s associated hospital as it was faced with software termination. As the termination date loomed, a team of researchers needed to find new software to store their data; primarily, their financial data. Storing active data in a clinical trial management system (CTMS) is a lifeline for the research teams relying on it for reporting and billing. Losing a system can be devastating.

Collaborating with Advarra’s Staff Augmentation team, our customer’s goal was to move active data from their sunsetting system into a new CTMS, OnCore. As I stepped in, I knew I needed to provide the team with direction on what needed to be done and detail how I would help. I started by making and presenting a plan outlining the details into three major steps: analysis, migration, and training.

Analysis

First, I gathered the needs of the team, including their workflows and processes. Understanding what they had previously done would also help me understand how OnCore could streamline and improve their workflows. Once I had an understanding, I held demo sessions for their team to help them understand how to effectively use OnCore with their research studies. Not only did this help staff learn how to use OnCore, but it ensured their new CTMS met their data standards.

I next worked with the team to dig deeper into what data they stored in the old software. I wanted to understand what the purpose of the data was, and how it was used downstream to help me translate the data into OnCore for the customer. The team reconsidered what data they should keep and decided how they could expand their reporting capabilities. Throughout our conversations, I took note of the terminology they used so I could use the words that meant the most to them later on in training.

Migration

During our analysis, we finalized the primary data set containing protocol information, subject details, billable visits, vendor payables, and events. I identified that the data in their previous software was limited compared to the data that OnCore can capture. This was a chance for them to do even more in terms of their data and CTMS and I reviewed these opportunities with the customer.

I successfully moved all the data on time and on budget. During the migration process, I once again took note of the changes and opportunities so I could highlight them during training.

Training

Training staff to use OnCore was the last phase of the project and is key for adoption and the successful use of new software. Due to customer bandwidth, I worked out a schedule and scope of the training to match their needs and availability. As we went through end-user training, I created streamlined manuals for their specific workflows that they could reference after my time with them was complete. This also provided their support team with a better understanding of the workflows and how the software can help them in the future. Towards the end of the team’s training, I could tell they were still getting used to OnCore being centrally managed and supported. To provide guidance after I left, I gave them a tip sheet of functionalities they could change themselves and what requires central change.

My time with the customer effectively allowed them to migrate their data and workflows into OnCore without interrupting study activities. By contracting Advarra’s Staff Augmentation team to assist with short migration projects, study teams have the ability to move to OnCore without taxing their highly valuable and busy internal teams.

When thinking about clinical trial documentation compliance, 21 CFR Part 11 usually comes to mind. For those unfamiliar with the Code of Federal Regulations designation, 21 CFR Part 11 provides criteria for electronic records, electronic signatures and handwritten signatures applied to electronic records. However, the criteria covered in 21 CFR Part 11 are not the only requirements that should be considered for compliant document management associated with clinical trials. Multiple other regulations require maintenance of general and trial-specific documents in regards to human subjects protection (45 CFR 46, 21 CFR 56, and 21 CFR 50), privacy and security (HIPAA, 45 CFR 160 and 45 CFR 164), financial disclosure of clinical investigators (21 CFR 54), new drug development (21 CFR 312), and device development (21 CFR 812).

Regardless of whether you are a sponsor or an investigative site, it is imperative that you have a reliable system and associated policies for storage and upkeep of documents surrounding trial conduct.

Consider Document Management at an Organizational Level

When seeking approval for a new drug/biologic/vaccine/device, you’re required to provide documentation associated with the progressing development of that new treatment, including regulatory documents, protocols, agent documentation, contracts, source documents, case report forms and numerous other documents from pre-clinical and clinical trials. Together, these documents make up the Trial Master File (TMF), which is used by the approving agency (FDA in the U.S.) to ensure complete information is present during the review process.

Due to the extent of the TMFs, and to comply with the regulations listed above, it’s also necessary to document many different infrastructure items needed to conduct ethical and compliant research. Items like: IRB rosters, IRB review documents, financial disclosures, training of individuals involved in the conduct of research, signed informed consent forms, drug receipt/disposition records, policies and procedures, etc. Many of these items surpass the level of a single study, or even a single treatment pipeline. Thus, it is important to consider how such documents will be stored and managed at an organizational level. This is done in two ways: processes and systems.

Implement Effective Processes and Systems

Organizations should have centralized policies on how required documents are to be kept. These policies should discuss:

How documents should be stored and made accessible while they are still considered active
Designate the responsible party for records retention
How and when to archive documents (NIH, FDA, and HIPAA regulations all differ and may not be the only ones that must be considered)
How long to store documents once archived
Describe a process for dispersion of documents that have expired

The other aspect of the organizational maintenance of documents is the system. While it is possible to store paper copies of all necessary documents, this comes with considerable cost and effort to ensure they are kept in a safe and orderly fashion. This also requires duplication of documents to ensure all files have every required/necessary document. For example, let’s say that our investigator has five clinical trials. For each of those trials, we have several shared documents, including the investigator’s CV, training certificates (e.g. human subjects training, HIPAA, etc.), conflict of interest disclosures, and medical license. Anytime any of these documents are updated, all five trials must be updated. Depending on the system in place, if documents are not consistently maintained, this can be a source of a large number of regulatory deviations.

The Office of Human Research Protections (OHRP), the Office of Civil Rights (OCR), the FDA, as well as other regulatory authorities, have stated it is appropriate to store documents electronically with proper safeguards, such as security and encryption. Should you choose to electronically store and maintain these documents, it is imperative to consider several items, such as chain of custody, audit trails for changes, security to ensure that electronic signatures are from the intended signee, electronic storage, and backup requirements/options, and accessibility.

Choose the Right System to Increase Compliance and Productivity

Use of an electronic system does not automatically remove the issues associated with paper systems. Policy regarding scans of wet signatures and whether those scans can be considered “original” (i.e. can you throw away the paper copy) are necessary. Electronic systems can be created that are essentially a glorified Windows Explorer file system. If a system such as this is used, you must consider processes on how to update multiple copies of the same document in different locations (e.g. study “binders”/folders, with different departments/compliance units) in addition to the security concerns/access issues.

More sophisticated systems, such as Advarra’s eRegulatory Management System, help organizations manage documents in an easy and compliant manner. These systems have technical controls necessary to validate the system to be part 11 compliant along with an organization’s policies and processes; have access restrictions to allow only authorized personnel access to specific documents; and have methods in place to disseminate updated documents to different locations, ensuring compliance across multiple studies. Such an approach will ease the burden of the researcher, study staff, and compliance units across an entire organization. This will decrease deviations associated with documentation errors and improve efficiencies associated with study monitoring and compliance auditing.

Learn more about Advarra eReg

Advarra eReg boosts compliance and productivity with workflows designed specifically for organizations focused on regulatory compliance across their entire clinical research portfolio. The system was developed through collaboration with industry-leading academic centers, creating unique efficiencies enterprise-wide. With 21 CFR Part 11-compliant electronic signatures, master delegation of authority workflows, efficient remote monitoring and more, Advarra eReg provides a comprehensive solution to streamline your regulatory management.

To learn more, request a personalized eReg demo for your team.

While there are many important aspects of a clinical research trial, the trial itself wouldn’t happen without research participants. Running a successful trial depends on recruiting and retaining clinical research participants. In order for individuals to participate in a study, they must receive information about what their involvement would include and voluntarily agree to participate, known as the informed consent process. Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and start a relationship between researcher and participant based on communication and trust that continues throughout the trial.

Informed consent is defined as the process of providing participants important information pertaining to the clinical trial, including what procedures they will undergo and possible risks and benefits. The information is intended to help participants make an informed decision on whether or not they want to start or continue with a clinical trial.

When is Informed Consent Obtained?

The informed consent of the participant must be obtained before any research procedures start. This is documented by an informed consent form (ICF) signed by the participant. This document is kept on file for the duration of the clinical trial, as well as a specified time period afterwards for auditing purposes. Participants must know key aspects of the protocol and understand their involvement in the trial is voluntary. They can withdraw from the study at any given moment, without reason.

Informed consent is not a one-time process; it is the start of a relationship based on communication. Research staff should not only obtain informed consent before any trial-related procedures begin, but consistently throughout the trial. Oftentimes, new information arises and changes elements to the trial that may impact the participants’ decision to keep moving forward. While they might have agreed to the protocol the last time, it doesn’t guarantee they will agree to keep moving with the study if it is amended. It’s essential to maintain ongoing conversations with participants, and ensure they continue to understand the protocol, their responsibilities as well as have their questions answered and agree to continue.

Conversely, there are times when informed consent is not needed, although these cases are rare. Informed consent is typically waived during emergency situations when it’s unfeasible to obtain consent from the participant – such as a critically ill subject. It’s important during these situations for doctors to act in the subject’s best interest, even if it means ultimately deciding not to include them in the trial.

Why is Informed Consent Obtained?

There are many reasons why a participant decides to join a clinical trial – they might want to advance science, or they may see it as their best option for treatment. Regardless of their reasoning, participating is voluntary, and subjects can opt-out at any time without any given reason.

Since it’s voluntary, a research participant needs to go through the informed consent process on a consistent basis. Informed consent is obtained to assure the researcher that the participant knows every aspect of their participation in the trial – what the procedures or treatments are going to look like and the potential outcomes, including the benefits and the risks.

Obtaining informed consent also benefits the research staff. A good consent process means the participant understands what is being asked of them. An ongoing consent process means the participant stays up-to-date on what is happening next in the trial. If they are fully informed and truly understand what is being asked of them, they will be more likely to stick with the trial for its entirety. This improves data integrity, ensuring the trial meets its scientific objectives.

How is Informed Consent Documented?

There are two main ways consent is documented: on paper and in electronic format. Regardless of format, there are common elements to making sure the participant has the information needed and voluntary consent is obtained with their full understanding.

Paper consent is collected in person with a research professional and the participant, whereas electronic consent (eConsent) uses hyperlinks, videos, and assessment tools to assist with understanding the consent document. To ensure the consent is complete, information is reviewed by a physician or by other individuals (i.e., researchers) with appropriate scientific training and qualifications.

However, it’s important for the research team member facilitating the consent processer to break down the ICF in simple terms for their participants to understand. Oftentimes, participants do not have a scientific or medical background and have questions or need clarifications. Participants may also want to meet outside of the initial meeting so they can ask any questions they might have thought of after the fact or to address any concerns. They should be allowed to take the consent form home to think about their participation and talk to others, such as their primary care physician or family, about whether participating in the study is in their best interest.

Participants are a key stakeholder in clinical research. Ultimately, if the participant feels comfortable and educated during the trial, they will be more likely to stick through the trial. Knowing the basics of when, why, and how informed consent is obtained and documented provides a great foundation for ensuring participant satisfaction.