Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly.  

With this in mind, we have outlined a checklist for researchers who are looking for guidance on study startup activities. We’ve included suggestions for optimizing each step to minimize delays and set your study on a clear path for success.   

About This List 

Careful planning from day one is essential for study success. The primary goal is to reduce the amount of time and resources required to activate a study.  Lists of various study startup activities vary widely depending on the level of detail provided. These elements are most critical and demand the most attention from sponsors, contract research organizations (CROs), monitors, and sites. 

Key Stakeholders 

Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to:  

  • Writing the protocol  
  • Funding and managing the budget for the study  
  • Engaging a CRO to assist in the execution of the trial 
  • Overseeing startup activities 
  • Collecting, storing, and submitting the data and documents associated with the trial  

CROs: Some sponsors may involve a CRO to manage components of the study. Typically, CROs are responsible for:  

  • Budget negotiation 
  • Engaging and selecting sites 
  • Identifying patient populations and supporting recruitment 
  • Overseeing training, conduct, and other processes across the study 

Monitors: Typically affiliated with the sponsor, monitors ensure appropriate and safe study conduct, as well as overseeing the progress of activating a study. Whether they monitor remotely or in person, they require detailed access to key study documents, standard operating procedures (SOPs), and more at each research site involved in the study.  

Research sites: Staff and investigators at the research site play a critical role in planning and conducting a clinical trial. They are responsible for but not limited to:  

  • Conducting clinical trial visits and procedures 
  • Collecting data during the visit 
  • Connecting with patients to recruit and retain participants 
  • Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility) 
  • Executing billing and financial workflows to maintain operations and compliance 
  • Communicating information to study stakeholders include status updates, essential protocol documents, and more  

1. Sponsors: Design and Optimize Your Protocol 

The clinical trial protocol organizes and dictates every component of study conduct. While each detail of the protocol is essential to study success, it also must holistically and realistically support study outcome goals. While many believe study startup is entirely reactive to the protocol, optimizing the protocol before it is ever in motion can greatly impact trial success. This may include reevaluating inclusion and exclusion criteria, enrollment goals, complicated or costly procedures, or other components. 

Early conversations with sites and patient groups will help ensure the visits and procedures are reasonable and achievable as study theory moves to the real-life setting. 

2. Sponsors: Build Your Budget 

Regardless of the type of study you are planning, building the budget is step one. You must get a handle on all the costs for activities happening throughout the life of the trial. Now is the time to thoroughly consider all the potential tasks and associated fees required. Consider the following: 

  • Do you need help writing the protocol?  
  • Do you need a data monitoring committee?  
  • Do you need endpoint adjudication?  
  • Do you need assistance or consulting help on any other matter?  
  • Do you need specific technology to collect or exchange data across stakeholders?  

All of these, and many others, will impact your study’s budget and should be accounted for at the outset. 

Let data inform your budget building process. Explore our resource: Study Activation Survey Results: Budget Negotiation 

3. Sponsors and Sites: Submit Materials to Your IRB for Approval 

Partnering with an experienced IRB increases opportunities to streamline the activation process. As you’re beginning your partnership with your IRB, setting clear expectations for each organization is beneficial during study startup and will also help maintain the relationship for future studies. 

Setting up a study kickoff call can ensure any key milestones or special requirements are understood. Scheduling this conversation upfront with an IRB will save both the sponsor and IRB time during review time. 

Need additional guidance on review requirements?  

4. Sponsors and CROs: Identify the Right Sites for Your Study 

To streamline startup activities, it is important to identify the most efficient and appropriate sites to conduct your study while your team might have a great relationship with a physician at a particular institution, it does not mean they have the appropriate patient population to achieve enrollment goals for the trial, or their institution has the resources to efficiently launch and run a study.  

Unfortunately, finding sites is a perennial problem—mostly because it is difficult to identify and connect with sites with the appropriate patient population for a study. Or once found, the sites are shown to lack sufficient staffing or resources to take on additional trials.  

5. Sponsors, CROs, and Sites: Conduct Feasibility Evaluation 

Protocol feasibility is the process of reviewing clinical trial logistics to determine if the site’s available resources are sufficient for trial conduct.

Site selection is informed early and most significantly by the feasibility questionnaire, a survey sent to all prospective sites. But if those questionnaires are deployed blindly to sites before diligent site planning occurs, it can result in responses failing to tell sponsors enough about the site’s feasibility for that specific protocol. 

A feasibility evaluation should include: 

  • Financial viability 
  • Available resources 
  • Past performance and ability to accrue 
  • Alignment with the study timeline 
  • Current staffing and turnover 
  • Competing trials and populations 

Sites are also responsible for completing and returning site feasibility questionnaires to inform selection and identify opportunities to take part in new studies. However, many questionnaires are redundant, or may not accurately capture a site’s ability to successfully conduct a study.  

6. Sponsors and Monitors: Conduct Pre-study Site Visits/Screening Visits 

Pre-study visits are the final and most crucial step in selecting appropriate sites. These visits are especially vital in cases where the research team has had no prior experience with the site. 

7. Sponsors and Sites: Initiate and Negotiate the Clinical Trial Agreement (CTA) 

The CTA is a legally binding agreement executed between sponsors and sites; one meant to protect both parties’ rights and interests. It covers delegation of responsibilities, obligations, allocation of risk, and financial commitments. Expect negotiations around this critical document and allocate time for them. 

8. Sponsors and Sites: Collect and Exchange Regulatory Documents and Critical Submissions 

Collecting and exchanging what are sometimes called the “essential” documents of the study startup process, is another place where teams will typically encounter issues slowing their progress, especially as these documents are numerous and complex. They fall into three general categories:  

  1. Federal/National Regulatory (i.e. FDA-USA, BfArM-Germany) 
  2. Institutional review board (IRB)/ethics committee (EC) submissions 
  3. SOP requirements 

Optimizing this process centers on removing redundancies and centralizing communication and exchange. For sponsors, leverage a centralized location – like in Advarra’s Study Startup Platform – to distribute, monitor, and retrieve documents across your sites globally. Centralization also minimizes requests for redundant information, or for documents you’ve already received like CV’s, training certificates, and more.  

For sites, it is important to leverage site-centric technology connected with the sponsor to ensure you’re receiving essential study communications like protocol amendments or updated informed consent forms (ICFs). By bringing your own technology to this critical step in study startup, you can maximize internal workflows when deploying documents to internal teams like quickly routing for investigator signatures and sign off, as well as returning documents quickly back to the sponsor

Learn more about how Advarra is streamlining document exchange across sites, CROs, and sponsors.  

9. Sponsors and Sites: Deploy and Complete Training 

Before a study begins enrollment, all relevant site staff must receive training and completely understand their roles. Any misunderstanding—or a lack of understanding—among site staff is a main contributor to delaying study startup progress or increasing timelines due to protocol deviations. Make sure your clinical team members thoroughly understand all the procedures, clinical and administrative, required of them by providing engaging and efficient training for each study.  

Pre-screening potential participants for a clinical study is common practice at most research sites. It can save time by quickly identifying those who may qualify for a study prior to having them move on to the informed consent process. Pre-screens can be done in person, over the phone, or in some cases, even online. The role technology can play in this process is important not to overlook. Regardless of the collection method, the questions and any accompanying script must first be reviewed by the IRB to ensure the materials presented are not beyond the scope of the inclusion/exclusion criteria.

Often, low accrual or delays in clinical trials stem from an undersized pipeline of potential participants. When site staff must manually find participants for trials, or even when automated recruitment solutions don’t deliver as promised, it puts the trial’s viability at stake, with sites and sponsors in the hot seat.

If more trials made pre-screening a fixed part of the study lifecycle in a way that optimized both personnel and technology, many of these problems might be avoided. But too often, comprehensive pre-screening is overlooked in favor of more familiar, but also more outdated, manual tactics. Here’s why that’s a mistake — and why pre-screening is the great missed opportunity for modern day trial enrollment.

What is Pre-Screening in Clinical Research?

Pre-screening activities take place at the outset of a trial, before informed consent. In this critical time, sites review the inclusion and exclusion criteria to determine a potential patient pool for the study. This information then gets reported to the sponsor so they can assess enrollment feasibility.

Ultimately, sponsors and sites aim to start with as many pre-screened patients as possible to maximize the participant pipeline. However, there are several different approaches to pre-screening and no true standard.

“Typically, sites conduct pre-screening manually through paper-based logs or printed spreadsheets that get emailed to sponsors,” said Gillian Barron, Senior Project Manager at Advarra. “This outdated method leaves ample room for incomplete information, typos and other human errors that delay reporting and inevitably, delay enrollment.”

As Barron adds, such manual workflows place too much expectation on overworked site staff with minimal optics for sponsors. But on the other hand, automated solutions place too much expectation on technology — without considering human capacity and strengths.

Who is Responsible for Pre-Screening?

When time is a precious commodity at a research site, it can be advantageous to delegate the pre-screening process to a non-clinical team member. Since the pre-screen itself cannot include any research procedures, it’s quite practical for anyone at the research site to conduct the pre-screen. It is important, however, to ensure the script used is well written and followed as closely as possible. A good script should:

  • Identify the staff member conducting the research and inform the subject of the type of the questions asked – that they are to determine eligibility only, and some may be sensitive in nature. If the staff member is not on the clinical team, it is best to disclose this so as not to give the subject the false impression they are speaking with a medical professional directly related to the study.
  • Tell the patient how long the call is expected to take, and offer the option of completing the pre-screen in person or at another time that might be more convenient.
  • Let the subject know they can stop the interview at any time if they don’t feel comfortable continuing.
  • When possible, a closing statement should inform the subject of what the next steps will include with a timeline. It should also indicate what will be done with the information collected (destroyed or stored, and for how long and where).
  • Concisely disclose applicable information to minimize future dropout rates.

As pre-screen questionnaires are completed, either manually or electronically, it is equally important to have an action plan to ensure eligible subjects don’t slip through the cracks and the information from those who didn’t meet the criteria are handled appropriately. Who will follow up with those who are eligible and when? Who will be responsible for managing the information collected? If the initial collection was done on paper, consider the advantages of maintaining this information electronically:

  • Easy information retrieval
  • Quick updates to answers or ability to complete unanswered questions at a later time
  • Analyze ineligible forms to modify questions if enrollment has slowed to a stop
  • If storing for a period of time, eliminate excess paper around the clinic
  • If using a clinical trial management system (CTMS), easily transition the subject from pre-screen to enrolled

The Role of Staff and Technology in Pre-screening

Given the coexisting barriers and opportunities of pre-screening, the optimal approach is to engage a platform designed to gives sites the tools they need for a more efficient process while also providing more transparency to sponsors.

Solutions like the pre-screen navigator within Advarra’s Study Collaboration platform is one example of a solution doing so with a cloud-based, multi-device platform. Built to standardize the complexities of pre-screening questionnaires, the Study Collaboration platform provides easy yes/no toggles for the most important eligibility criteria.

The completed form then gets presented in real-time to sponsors, who can see pre-screening activity on a global, regional, and site basis. Study teams can see where the patients are located across each country and gain early insights into which of the inclusion or exclusion criteria are causing most prospective patients to fall out of the funnel. This removes the delays inherent in paper-based logs.

“It’s so important for sponsors and study teams to have this information available to them in real time,” Barron said. “With that insight, they can more quickly identify trends, discover pre-screening failures, monitor site performance and consider amendments to expand the participant pipeline — all at the very beginning of a study.”

Case Study: Increased trial enrollment via Pre-screen Navigator

Boosting Trial Success with Pre-screening

As sponsors look to expand their participant pipeline, pre-screening is an essential part of the clinical trial ecosystem. However, not all pre-screening methods are effective. Failure to optimize this critical process can impact study timelines and ultimately, delay commercialization plans and treatment to patients.

Pre-screening is a common strategy to add to any patient recruitment campaign. Fortunately, there’s a better way to do pre-screening. To maximize your pre-screen activities, make sure you have a well-written script, ask the right questions, and have a follow up plan in place.

Additionally, using technology to help manage your pre-screen paperwork and records can serve many purposes. With streamlined technology like the Study Collaboration platform’s pre-screen navigator, site staff can more easily do their jobs while getting back to what matters: their patients. In turn, sponsors can have the real-time insights they need to make decisions that affect the success of current and future research.

This blog was originally published Jun 21, 2013 and has been updated.

Like every institutional review board (IRB) – commercial or local – Advarra is subject to inspections from time to time. The Food and Drug Administration (FDA) inspects IRBs to ensure human participants’ rights and welfare are properly protected. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Additionally, many of our clients audit the IRB.

It’s critical for the IRB to follow appropriate regulations and guidance in its reviews, ensure reviews are conducted free of bias and conflict of interest (COI), and conduct due diligence to confirm quality is upheld for the studies they oversee. We welcome these inspections and audits at Advarra, as they help us continue to improve our processes while ensuring participants are properly protected.

Most IRB inspections and audits focus on some common elements. This blog aims to provide an overview of such items to help you understand the standards to which Advarra’s IRB and others are measured against.

IRB Assessments Overview

Let’s take a quick look at some of the entities most commonly inspecting IRBs.

FDA

IRBs can expect formal FDA inspections every few years, but there’s always a possibility of the agency showing up unexpectedly for an ad hoc inspection. The FDA inspects IRBs to ensure participants’ rights and welfare are being appropriately protected, which also helps confirm expectations set by IRB clients and the IRB itself.

Typically, when the FDA performs an inspection, they request to review specific studies. If the inspection entity provides the names of the studies in advance, this enables us to pull all necessary information ahead of time to provide inspectors and notify the study sponsors of the upcoming inspection (as applicable), preparing them as well.

AAHRPP

While AAHRPP accreditation is purely voluntary, it is a rigorous process underscoring Advarra’s commitment to high-quality IRB reviews and scrupulous standards of quality, ethics, and protections for human research participants. To receive AAHRPP accreditation, there are certain requirements:

  • Self-assessment, application, and peer review of application
  • Site visits
  • Annual reports to confirm ongoing compliance and maintain accreditation

IRB Clients

IRB clients, including industry sponsors, contract research organizations (CROs), research sites, and others, typically have choices when selecting an IRB for a given study. By and large they seek an IRB with a strong reputation for quality and compliance – these are fundamental expectations.

Selecting a less-than-compliant IRB can not only jeopardize participant safety but also impact study data and the research organization’s reputation with regulatory agencies and the general public. It’s important for certain clients to evaluate their IRB partners just like they would conduct a risk assessment with any other vendor.

Compliance with Applicable Regulations

Abiding by the appropriate research regulations is the right thing to do, it’s legally required, and it’s the heart of the IRB’s mission.

We note “applicable regulations” as the regulatory requirements can vary depending on the study in question. Inspectors are concerned with not only whether the IRB follows the regulations but also whether the IRB applies the regulations appropriately to a given study. Not all oversight requirements are appropriate for all studies, and an IRB should carefully review each study to determine the applicable regulatory requirements and what is best for that study’s participants.

Compliance with Standard Operating Procedures and Organizational Policies

Our policies, standard operating procedures (SOPs), and work instructions are designed to bridge the gap between what must happen and how to accomplish it. They also help fill in the blanks and flesh out requirements when regulatory guidance leaves room for local interpretation.

When policies and SOPs align with regulatory requirements, it enables compliance. These documented processes further prove to our stakeholders that we do what we say we are going to do. If a sponsor is concerned about how the IRB handled a particular review, the IRB should be able to use these policies and procedures to explain why things played out as they did. IRB meeting minutes are critical as the source of documentation of an IRB review and determination.

Compliance with Other Requirements

In addition to adhering to federal requirements and organizational polices, IRBs may have additional obligations to meet. AAHRPP accreditation is one such example. At Advarra, AAHRPP accreditation helps provide further evidence of the thoughtful processes and expert insights that power our HRPP, since everything we do is to protect participants.

Independence of Review

As an independent IRB, Advarra has firewalls and policies to guarantee the decision-making independence of these panels. These structural safeguards and corporate policies – which should be in place at any IRB – ensure the open deliberation that embodies the spirit of the regulations. Examining IRB policies and SOPs, as well as reviewing IRB meeting minutes, can help inspectors confirm reviews are conducted independently, without outside priorities influencing the decision.

Some may perceive that the effectiveness of commercial institutional review boards is limited by business interests. However, commercial IRBs must adhere to the same regulatory requirements and quality standards expected of any IRB – the influence of COI is a concern for all IRBs, not just commercial ones. Commercial IRBs and COIs may just get more attention because of the nature of the business.

At Advarra, we ensure independence of IRB review in several ways, including:

  • Company policies
  • A reminder at the outset of every IRB meeting for board members to recuse themselves from discussion if they have a COI
  • Structuring the organization to keep the IRB completely shielded from business priorities and unaware of the fees associated with review services, so that members focus only on the needs of research participants

In our highly regulated clinical research industry, regular inspections are standard practice. IRBs often inspect research sites to confirm researchers are doing what they said they’d do; likewise, IRBs can expect regular inspections by stakeholders. These regular checks ensure that we are doing our best to protect study participants and move research forward.

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. How can we make clinical research more accessible to anyone who wishes to participate? Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges.

The concept of DCTs brings the trial activities to non-centralized places, closer to participants, so they have better access to the interventions and measures involved in conducting a trial. Ways to accomplish this include engaging home health groups to come to the participant’s home to collect or administer study tasks, or bringing interventions into the community by setting up a common place for interventions (e.g., collecting blood pressure at a barbershop). Utilizing remote technology is another way to aid in convenience and accessibility.

These activities provide more flexibility for participants. Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial. Funding, sponsorship, tasks to be conducted, and the legal structures of entities may impact sites and the study overall.

Why do Funding and Sponsorship Matter?

Who sponsors a study and how the study is funded are key drivers for determining the trial’s regulatory oversight framework, as well as the framework used by the IRB to review it. This means the requirements will vary slightly depending on which entities fund the trial.

For example, consider a trial funded by a Department of Health and Human Services (DHHS) agency such as the National Institutes of Health (NIH). Trial activities and places where the trial is conducted must also have IRB review if they meet the definition of “engaged” in research under the DHHS/Office of Human Research Protections (OHRP) framework.

In contrast, if a study is sponsored by industry (e.g., a pharmaceutical company) and involves no federal funding or support, it would fall under the Food and Drug Administration’s (FDA’s) oversight—and the concept of “engaged” is not included the FDA framework. However, sites and individuals conducting the industry-sponsored trial could be required to be listed on the Form FDA 1572—if this is the case, those sites and individuals would be subject to the FDA regulatory framework which require IRB review of the activities.

The concept of “engaged” in research is not easy to decipher. It can be further complicated by the types of activities and determining if they “engage” a site in the research, or if the site or individual conducting the activity should be listed on the 1572.

How Does Legal Structure Impact the Decentralized Clinical Trial?

Another consideration to explore is the legal structure of the site, sponsoring site, or entity where the research occurs and who can provide oversight. This concept is a bit more nuanced, but it could make a difference in how trials are set up and conducted with respect to IRB oversight.

For example, an academic medical center (AMC) may employ its investigators as staff. Since investigators are employees of a larger entity, they may not have the authority to delegate trial oversight to another entity, such as a home health group. If the home health group is conducting research activities, they would need some authority or oversight to be able to conduct their activities, such as a separate IRB review, either by the AMC’s local IRB or by a separate independent IRB.

There would have to be an agreement between the home health group and the hospital on which IRB (the AMC’s IRB or the home health group’s IRB) would review on behalf of and provide oversight for the home health group and their activities. It is important to know how your site is structured to be sure everyone can be covered in the most effective way in DCTs.

Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System.

Q: How do you promote a quality culture when senior management has a lack of knowledge of quality management systems (QMS) and is more interested in deliverables rather than quality? 

A: That is a tough one. First, congratulations on realizing such a mindset may exist. Acknowledging and identifying QMS resistance and its root causes is an important step when addressing it. Management surely has an interest in successful, prioritized “deliverables”. Teaching them to understand doing things right and on time with desired, well-controlled results is the definition of quality. Again, quality is the successful outcome of the fulfillment of customer requirements – so if management (business or project) is focused on fulfilling customer requirements, then they should be highly interested in quality.

The process descriptions (procedures or standard operating procedures [SOPs]) should reflect the way things are done or are supposed to be done, promoting efficiency and effectiveness. This ensures quality results are delivered.

Organizations can promote a quality culture through seeking agreement and gaining enterprise alignment of harmonized processes. This enables them to perform actions and initiatives in a reproducible and effective way.

Q: What are the key factors to consider when merging two contract research organizations (CROs) from two different countries? (Harmonization of the QMS and all SOPs, etc.) 

A: The webinar discussed the following factors:
  • Conduct a thorough assessment of each site’s QMS
  • Align and compare each QMS to the parent company
  • Evaluate the organizational setup as well as the cross-functional disciplines

If both CROs are doing similar tasks, they can develop and roll out a more common QMS across both sites. If they are different in their functions, organizations can conduct strengths, weaknesses, opportunities, and threats (SWOT) and task analyses to help drive the QMS selection as they harmonize and align both processes into one.

Q: What are some of the quality processes for the transition from paper to electronic? 

A: To create a smooth and seamless transition, this process must be carefully designed in a project. There are several factors to consider – most importantly are the many principles of data integrity to apply when, for example, migrating records and data into an electronic system (as well as data originality, true copy validation, etc.).

An evaluation regarding changes in the existing process should be conducted. Based on the nature of the electronic system, processes may change and/or adjusted to account for new requirements.

Consider all relevant equipment and computerized systems and potentially a stepwise inclusion in the electronic QMS developed. Doing it all simultaneously may overwhelm some organizations and quality systems (processes). Overwhelming the system could lead to increased numbers of deviations, which should be avoided at all costs.

Q: I am being tasked to build a “roadmap” of GCLP. What does GCLP entail? 

A: If the GCLP term referenced is interpreted as a combination of good laboratory practice (GLP) and good clinical practice (GCP), then the roadmap needs to include processes covering pre-clinical and clinical development stages. Covering the pre-clinical and clinical stages in development, this also means early inclusion of current good manufacturing practice (cGMP) requirements for any clinical trial material produced. Even at the contract development manufacturing organization (CDMO), the clinical study sponsor must assure oversight.
Creating a compliant QMS and an effective roadmap requires a comprehensive, customized evaluation to ensure fit-for-purpose quality systems at every phase.

Q: Currently in the final stages before organizational implementation, what is your best tip to prepare before launch? 

A: From a quality and QMS perspective, all the processes are already built at this stage. Receiving market launch approval requires completing the preparation for a pre-approval inspection (PAI) and transferring the production process into the area which will produce for market supply. This area needs to operate under full cGMP (manufacturing, quality control [QC], packaging, quality assurance [QA], and logistics).

If product supply is done externally, the product sponsor must assure appropriate CMO/CDMO quality oversight.

Q: What are some important issues that you recommend keeping an eye on during implementation? 

A: After completing the assessment and developing the QMS implementation roadmap, it is especially important to carefully follow the project plan. Many processes may be defined through SOPs. When a detailed process evaluation is done, the organization can then evaluate any changes and proactively address identified issues.

There may be cases when the existing process needs adjustments based on regulatory requirements, and/or compliance issues. In such cases, existing habits or behaviors require change accompanied by the requisite organizational training and communication.

In a good, and effective implementation, there should be flexibility and repeated consideration for adjusting the path, so the new quality systems (procedures) are fit-for-purpose and support the ongoing activities, and not complicate or overly formalize them.

Q: What have been the biggest challenges in implementing QMS? 

A: When a company is already further along in its growth and product development, it becomes more challenging to educate and build the understanding that quality is not a superimposed formalistic bureaucratic system. It’s merely the reflection of the ongoing process descriptions which help propel a company’s success. Additionally, companies at a later stage of development need to “catch up” with building their QMS from the foundation to their current stage of development. In these cases, companies may need multiple quality systems to also fulfill the regulatory requirements.

Q: How often should management reviews occur for startup biotech organizations? 

A: There are probably already organizational or management meetings with development staff (project management meetings) continually evaluating ongoing activities and initiatives. These meetings can easily integrate quality aspects and review ongoing processes for performance. The organization may already track some key performance indicators (KPIs) regarding performance in product development and projects. Those would be the quality systems for review at this early stage.
With more quality processes added, the meeting may vary in terms of meeting time, content, and scope.

If kept separate, a management review can occur on a quarterly basis in earlier stages, moving to monthly while advancing through phases and including more quality systems.

Q: Startups may not have the budget for early implementation of QMS systems, e.g., “well-defined archives” or validated clinical safety databases. Please comment on options for use of “lite” versions of such archives/databases that can be scalable as the company grows. 

A: The first option is to avoid costly, electronic QMS systems at the early stages. A company may implement a paper-based QMS with policies and procedures. These may be archived in folder structures using available file management systems. This may be scaled for company growth, and at a suitable time, could be converted into electronic systems. However, this is not a requirement, and it may not deliver an enhanced level of compliance.

Q: How do you effectively create a quality culture in a fully remote organization? 

A: Working in a remote environment may pose additional organizational challenges. It is important to enhance communication and establish open dialogue and transparent processes. In all communication, the organization needs to demonstrate loyalty to its statements, processes, and procedures. A quality culture relies on trust and understanding, which is achieved through open communication and clear commitment to quality in all aspects (e.g., managing projects, business, and compliance).

Q: Please expand on successful working practices to implement a QMS by academics who are initiating a “startup” company, often with very few people and dominated by academic work standards for organizations and protocols that do not include similar QMS “culture”. 

A: This may be a special situation, yet it may follow a similar pattern as described in the presentation.
Start with an assessment and evaluate the situation of the team and startup. For both academic and early-stage companies, scientific development activities should have a minimum number of procedures to establish. Companies can adapt procedure content to the academic environment and simply reflect the processes as they are supposed to be executed. Such a description may help to align the way things are done and how to conduct research. Future data and record review is better supported – e.g., tasks like writing scientific papers may be more efficient.

Q: When should you start to establish quality metrics? 

A: As soon as quality processes are established, monitor them for performance. Early processes perceived as project management and scientific product development may receive performance tracking. If so, quality aspects may grow organically for the organization and a quality culture is built along with it.

Q: What do you mean by “validation due diligence”?  

A: This is meant for processes when an identified target is confirmed and validated.
The due diligence process may occur when an asset (target, application programming interface [API], or similar) is acquired for further product development. In the process, there is a due diligence evaluation to support the decision.

Q: When do you implement your QMS? If your organization begins at the development stage (virology), then progresses through pre-clinical immunology), to Phases I, II, III clinical, where should you enforce the rules/guidelines of a QMS? 

A: You should enforce QMS guidelines or rules when:
  • You expect processes to be established and followed
  • Data is created and may impact decision making in the development process or referenced at a later stage

Whenever defined, adhere to each process, and expect repeated execution for certain tasks. Then, develop and implement your QMS. It should allow for clear process definition, documented description of how to conduct tasks, and archives developed in a manner where data and records are easily organized.

In the case of the example given, the recommendation would be to already have a QMS as any new development process begins.

Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error.

That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical trial management systems (CTMS), and other eRegulatory (eReg) platforms all contribute to a more efficient and compliant trial. With hundreds or even thousands of files part of a trial’s documentation, an integrated eReg solution can facilitate vital time savings per document and ensure improved data quality – yielding a valuable return on the investment in the integration.

This article outlines common eReg management system integrations, and highlights a new integration already allowing sites to save hundreds or thousands of dollars per protocol.

Current eReg Integrations

As clinical research continues to move towards a remote environment, centralizing and integrating your regulatory management process and technology is vital to your institution’s success. There are common eReg integrations clinical trial sites are currently implementing.

CTMS Integration

An organization’s CTMS is commonly the source of truth for all protocol and participant information. CTMS data includes information related to protocols, staff, and your organization as a whole. This integration allows for organizations to level up their technological workflows, such as streamlining protocol creation within the system, associating staff with those protocols, and facilitating delegation of authority.

Email Integration

Correspondence and supporting documents between sites, sponsors, IRBs, and other stakeholders are essential to house in a protocol binder. However, manual workflows associated with downloading and uploading email messages and attached documents hinders efficiency, especially during study startup. By leveraging an email integration within eReg, you can easily send emails, as well as any attached documents to quickly review, and associate them with the appropriate protocols in the system.

eReg-to-eReg Integration

If you are the coordinating center for a multi-site trial, you can ease regulatory burden not only across your organization, but across participating sites through the Advarra eReg-to-eReg integration. When coordinating multi-site trials using Advarra eReg, the sponsor or coordinating center can house their own documents related to studies and the files of all participating sites, organizing everything in a site-specific folder structure. Facilitated by a multi-site protocol connection, the coordinating site can request documents from the participating site, and the participating site can easily send the appropriate documents as requested.

Sponsor/ Contract Research Organization (CRO) Systems Integration

These integrations ensure sites to compliantly and confidently execute the protocol, empower and inform study participants, and efficiently manage and monitor studies within one intuitive platform.

The challenge for sites and sponsors is ensuring these interfaces connect with one another and with technology across the enterprise. If they do not, they may encounter duplicate or disconnected data, affecting outcomes and efficiency.

Advarra eReg-eIRB Integrations

To achieve connectivity and support clean data, optimized workflows, and compliance, a unified eReg integration is essential. Advarra eReg provides integrated protocol, staff, and institution documentation to streamline regulatory process and enhance compliance. Advarra offers two system options:

  • eIRB integration: Documents shared between your IRB and organization are an essential component of your long-term binder storage and are often updated and routed throughout the study’s life cycle. By utilizing integrations from both central and local eIRB systems to your eReg system, you can reduce manual effort and increase compliance by syncing important documents via central intake processes.
  • CIRBI integration: In addition, Advarra eReg supports integration with Advarra’s Center for IRB Intelligence (CIRBI) Platform and connections with your local eIRB system. With this IRB integration, all approved documents are immediately accessible for your regulatory and clinical staff in eReg to take the necessary action. This also allows you to decrease time and effort needed to manually download documents from an external system and upload them into your regulatory binder across your institution’s research portfolio.

ROI Benefits of CIRBI Integration

By eliminating manual document management, trial teams can save upwards of five minutes per document.[1] With an average of 200 documents per protocol that would leverage this type of integration, that amounts to 16 hours saved per protocol. For sites with a significant research volume, this can amount to tens or hundreds of thousands of dollars in full time exempt (FTE) savings over time.

The time savings are generated by the automation behind Advarra’s CIRBI Platform, which enables real-time communication among sponsors/CROs, research sites, study staff, and IRB members. For example, following the initial submission, all IRB-required documentation and submissions are readily available in the CIRBI Platform, and you’ll receive instant notification of and access to IRB correspondence and the ability to view the original regulatory documents 24/7.

With the CIRBI integration, you can accelerate your clinical trial’s startup phase and be confident in the quality of your document data throughout the course of the trial as you save valuable staff time.

[1] According to Advarra data based on a top 10 biopharmaceutical company

Did you know 70% of the variance in team engagement is attributed to an employee’s direct manager? This means the focus must not only be on the clinical trial associates (CTAs), but on the one driving their performance and engagement: their manager. The organizational shift to CTA centralization provides the ideal momentum and focus: invest first in those who lead your entry-level CTAs in their capability as people managers as opposed to being technical experts.

Enrich existing one-on-ones by preparing CTA managers for check-ins going beyond progress reporting. This is an already-existing time on both the CTA’s and their manager’s calendars, but too often these regularly scheduled moments are not fully leveraged. While most one-on-ones address the CTA’s work status, inserting a quarterly one-on-one reserved for understanding what is going on with the CTA – the person – can result in an enlightening conversation. Asking questions such as what motivates the CTA or how they would like to learn and grow can go a long way in these one-on-ones.

For example, the benchmarking exercise on CTAs uncovered an interesting trend, moving away from requiring specific experience in a therapeutic area, and focusing more around minimizing administrative activities and increasing broad cross-functional and cross-therapeutic area experience.

How can we leverage this trend to inquire about CTA interests beyond the clinical studies they are currently working with? We must seek first to understand their motivations, and eventually, broaden their experience on what matters: cross-therapeutic areas, study phase, endpoints, and patient populations.

This may seem foreign since there are so many niches within life sciences, however, it’s important to think about breadth versus depth early in a CTA’s career. As their career progresses, they can choose which path is best suited for them.

Managers need to prepare before these quarterly one-on-ones and gain the appropriate support from organizational leadership. Without it, managers may shy away from these conversations, assuming their direct report will bring it up. There is plenty the manager can say or do. They must recognize employees’ desire to learn and grow and their need to feel their manager is invested in their growth and development.

A direct manager’s role cannot be overstated. They can provide a variety of ways to build a CTA’s skills such as:

  • Ensuring exposure to functional cross-functional capabilities
  • Inviting employees to join or present in a meeting
  • Providing opportunities to participate in the strategic task force
  • Learning new skills or gaining insight into diverse therapeutic areas

All strategies are typically within a manager’s sphere of influence. This is perhaps one of the fastest ways for a quick win with CTA managers and CTAs.

Supporting a Culture of Cross-functional Collaboration

A recent Advarra client engagement revealed cross-functional collaboration was prioritized as the behavioral competency required for clinical study team members, where matrixed teams cut across functions to influence, negotiate, accelerate, and manage clinical studies from design to completion.

The solution to enhance cross-functional collaboration is well-researched, but not well-advertised: it is precisely about creating internal mobility across functions. Fostering collaboration and innovation are specifically called out as a strategic purpose in the Conference Board’s Report.

Total talent mobility is an important lever, helping to expose employees to new perspectives, learn and adapt, build their networks across the organization to strengthen collaboration, and break down organizational silos.

The perfect environment to foster such mobility beyond traditional linear advancement typically requires high volume, early-in-career roles, which you have with CTAs (and other roles such as clinical research associates [CRAs]). This critical mass of CTAs along with your front-line CRA staff populations is the ideal place to introduce greater internal cross-functional mobility.

Sideways moves no longer sideline talent. Instead, lateral moves can lead to bigger and better opportunities.  People who can fulfill multiple roles build resilience and position themselves as valuable resources in a changing environment –Up is not the Only Way, Beverly Kaye

While this strategy is not complicated to understand, it requires steadfast commitment to implement well, and will not happen overnight. There are three common barriers to address and insights to gain traction in creating “zigzag” internal mobility:

Barrier Gain Traction By: 
Talent hoarding: Leaders’ resistance to releasing talent to another team Prepare your clinical leaders to fully understand exporting their team internally is part of their responsibilities and a strategic priority essential to organizational success. After all, if they don’t embrace exporting internally, they stand a real chance of losing them externally.
Compensation: Small percentage increases which have traditionally signaled advancement Partner with human resources to review the essential “zigzag” moves to remove negative impact or incentivize movement. Create exceptions to protect grade and salary as needed, eventually making exceptions to the rule. Create innovation such as inserting “development” increases within the grade.
Narrative: Being promoted is the only way to advance Create a new narrative for leaders and staff to drive readiness and adoption of a mindset shift. “Our company also values the breadth of experience; career progression is no longer purely vertical or a function of time in the role.”

Create a new narrative for leaders and staff to drive readiness and adoption of a mindset shift. “Our company also values the breadth of experience; career progression is no longer purely vertical or a function of time in the role.”
Those who are interested in enhancing cross-functional perspective and experience may differentiate themselves to compete for future opportunities”

Wholistically aligning each lever will enable organizations to simultaneously achieve desired change and address existing barriers.

A tight talent market, heavy attrition, headcount constraints, and a pandemic facilitating global moves without physical relocation all point to a unique moment to maximize internal mobility. Just a few years from now, your organization could have a pipeline full of highly qualified study team leaders with a deep understanding across multiple functions, who have built strong networks and partnerships, and who demonstrate collaborative excellence.

Most organizations understand the importance of creating a competitive advantage with a targeted, aggressive hiring strategy – but why is this typically exclusively focused on external candidates? While this makes sense at the entry-level, oftentimes, employers are overlooking a critical talent pool available to them: their current employees.

While we usually think of our leadership roles as impact roles, it’s time to rethink highly impactful entry-level roles. For example, organizations may want to consider hiring a clinical trial associate (CTA) with a career in clinical research in mind, rather than just for this first role.

Think of the traditional purely linear talent pipeline – a CTA that may advance to CTA II or III, or perhaps progress into a clinical trial manager (CTM) role. This type of advancement no longer meets the needs of complex, global study team environments where multiple, interdependent perspectives weigh in to develop the best paths for study success. What is missing is strategically utilizing early-in-career movement to break the silo mentality. This can add tremendous value by rotating staff, enabling them to gain a deeper understanding of the challenges they will experience throughout their career.

To realize this potential, the highest leverage in building an internal workforce is to engineer “zigzag” career moves, rather than exclusively linear. It begins with understanding transferrable skills that can apply to other roles in the organization as a job moves to address organizational ebbs and flows.

For example, a CTA I becomes a clinical research associate (CRA) before advancing as a CTA II. A CTA II could benefit from a cross-functional rotation before elevating to a CTA III. It also works in other ways such as a CRA can move to become a CTM. As the benchmarking exercise illuminated, large hierarchical biopharmaceutical companies are seeking ways to break functional loyalty and silo mentality to become more agile and operate successfully in a cross-functional matrix. What better way than to build these future lateral leaders with your entry-level talent?

Reimagining the Linear Path Mindset

Why isn’t the internal hiring strategy more widespread? Simply, there is no quick fix – many organizations look to bring in outside, experienced, “ready-made” talent as a quick fix.

To change the mindset to invest from within, here are a few thoughts and ideas to consider:

  • It is rare to find a job posting these days that does not require multiple years of prior experience in an extremely specific niche. This is what recruiters call a “purple squirrel” – something that simply does not exist. These wish lists are not only unreasonable, but they cause you to believe there is no one relevant internally to consider for the position, when in fact there may well be. Rather than hiring these expensive “squirrels” externally, employers would often be better off placing a bet on someone internal who is a fast learner, can learn on the job, and will go the extra mile to prove they were worth the risk
  • There are several advantages of internal candidates, many of which are often overlooked. Your current employees already know your values as an organization, how to navigate the culture, how to get things done, and how best to communicate. They can hit the ground running, rather than spend substantial time acclimating to your organization
  • Even more important, you know so much more about your employees than you will ever know about an outside candidate, including their strengths and their developmental needs
  • Take the “purple squirrel” metaphor seriously, by taking a critical eye – and the delete key – as you edit your job postings. Understand which qualifications are truly required, which are preferred, and if any transferrable skills may apply. If there are skills candidates can learn on the job, list those as well. This will significantly enhance the potential for internal employees to qualify as candidates, and for employers to initiate a “zigzag” path

While these actionable strategies are not complicated to understand, they require steadfast commitment to implement well, and will not happen overnight – especially since strictly linear paths are well worn over multiple decades. Insights and ideas for addressing the barriers and managing the cultural changes required to create “zigzag” internal mobility for another post. And, while we focus on the CTA, these strategies can apply to an entry-level position in the organization.

Now more than ever, there is enormous pressure to deliver products to the market faster and cheaper. In the clinical research industry, this means a constant focus on innovative technologies, advanced trial designs, specialized areas of focus, and improved processes.

Millions of dollars are spent on these initiatives and the restructuring of organizations. While these go-to strategies are essential, they may be insufficient. These strategies disproportionally receive top prioritization, enterprise energy, and funding. People and the environment they work in – the culture – are arguably the two most critical organizational strategies to achieve the desired change. However, both are either absent or receive little attention. Decades of research have demonstrated these initiatives will fall short without including a serious investment in people and culture.

Think about your own industry experience, when an initiative did not meet its potential for desired, sustainable change. Was it the process, technology, or structure? Or was something else getting in the way – like a silo mentality, a blaming culture, or another manifestation of the day-to-day work behaviors? 

Let’s take a relevant example. At your organization, compare the resources and attention dedicated to implementing innovative technologies impacting multiple functions to the resources allocated to developing the people skills to work effectively in a complex study team environment.

Why has the clinical research industry been reluctant to focus on people and culture? Are we more comfortable focusing on process and structure? Maybe we just need some guidance on where to begin or how to build on work already started.

This blog series provides an approach to building an agile workforce, becoming resilient to change, and developing an innovative mindset ready to futurize the industry. It begins with a recent trend observed during an industry benchmarking exercise focused on understanding how the clinical trial associate (CTA) role fits within the organization. Specifically, the goal was to obtain industry insights on whether the CTA role was centralized (pooled with functional line managers) or decentralized (reporting to trial managers).

Results from the benchmarking exercise indicated one-third of the companies had an established organizational structure for five years or more, with the remaining companies reorganized within the last five years. For three of the four companies reorganizing in the last year or two, the redesign included CTA centralization.

When asked about the rationale to create a centralized CTA function, companies responded the driving force was to address issues such as:

  • Silo mentality
  • Consistency and efficiency
  • Resource planning and flexibility
  • Eliminating redundancies

While these are good reasons to support an organizational change and it’s easy to measure improvement, they cannot stand on their own to achieve the full potential of centralization.

Centralized or not, companies acknowledged two current challenges they face: recruitment and retention. Additionally, they recognized the importance of focusing on engagement and skills. A trend intended primarily for efficiency, the redesign further ignites one of the industry’s leading challenges – attracting and retaining talent. Easy to talk about it, but how can we take the steps towards implementation?

In an industry where disruption and organizational redesign are a constant, investing in CTAs early in their career will result in a resilient workforce ready to take on advanced roles in the organization. This approach is also more likely to provide functional loyalty while also addressing silo mentality challenges. As a bonus, investing in talent creates a critical competitive advantage by mitigating significant challenges with recruitment and increasing colleague engagement and retention.

An incidental finding is a “finding” or result from an intervention or test that uncovers a condition or problem that was not originally known and was not part of the expected test-result scheme. Simply put: it is something extra found from a test.

Discovery of these extras can result from a standard, approved clinical test or intervention. They can also be found from a research test or intervention. Each incidental finding has an impact on how research professionals handle the result and what you do with that result.

Plan Ahead

If you are conducting research that has a potential to uncover an incidental finding, it is best to plan ahead for how you’ll treat the result and if you plan to return that result to a participant.

Returning results to a participant when an incidental finding has been uncovered may seem easy and straightforward. However, there are many considerations to think through before returning any results. And while most participants desire to have their results returned, there are circumstances where it might not be in the participant’s best interest to receive a result.

It is important to consider the design of the research, as well as the interventions proposed, in order to formulate a plan for if and when any incidental findings should be returned to individual participants.

For example, is the intervention done for research purposes, standard care, or both? If the intervention is done for research as well as for standard clinical care, and the interpretation of the results would occur anyway, the results should be disclosed to the participant and/or the participant’s physician.

However, if the research intervention is not approved for use clinically, generally, the findings should not be disclosed to the participant. This information should clearly be outlined in the informed consent form (ICF).

Research-only Results

Returning results may seem fairly straightforward and easy to implement; however, it gets trickier with research-only results. For example, consider a research intervention that is approved clinically but done solely for research purposes and will not be professionally interpreted. In this case, the results should not be disclosed unless there is a plan to provide interpretation by someone qualified to interpret the test, image, or intervention. There should also be a plan for follow-up interventions or discussions (e.g., genetic counseling, continued treatment). This plan should be documented in the protocol.

Another nuance to consider is if the research intervention is approved clinically but done solely for research purposes, and the principal investigator (PI) wishes to give the participant the option to receive results. Here, the PI must track which participants want results and which do not. This option must also include a plan to provide interpretation by an appropriately qualified person and a plan for follow-up intervention or discussion. These plans must be documented in the protocol.

Plan Ahead, Even if You Don’t Expect Incidental Findings

There may be circumstances where neither the protocol nor ICF mentions incidental findings. This could be because the test or intervention was not likely to provide incidental findings or because it was not contemplated during the study design. If this occurs, it may still be appropriate to formulate a plan to return findings to participants under certain circumstances.

Examples include any information collected through a clinically accepted method (e.g., a Clinical Laboratory Improvement Amendment-certified [CLIA]  lab or an otherwise validated test center and/or method), plus any information that:

  • Reveals a condition likely to be life-threatening, or liable to be grave and can be avoided or ameliorated,
  • Reveals a significant risk of a condition likely to be life-threatening,
  • Reveals genetic information that can be used to avoid or ameliorate a condition likely to be grave, or
  • Any test that reveals genetic information that can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be life-threatening or grave, or (2) to ameliorate a condition likely to be life-threatening or grave.

It is also best to consider and discuss with the participant additional treatment options or communication paths with other providers, genetic counselors, etc., as well as the potential costs associated with those treatments and/or provider visits.

Conversely, in general it is best to not disclose to research participants any finding that:

  • Was not collected through a clinically accepted method (e.g., a CLIA-certified lab or an otherwise validated test center and/or method) or is not an otherwise validated test or method
  • Reveals a condition that is not likely to be of serious health or reproductive importance
  • Reveals a condition or information that the importance of which cannot be ascertained

After 20 years of supporting clinical trial sponsors, the team at Advarra knows success depends on having a good committee charter. Independent data monitoring committees (DMCs/DSMBs) and endpoint adjudication committees (EACs/CECs) rely on the charter to set the course for project and the conduct of the committees. All of them have one thing in common: Success depends on having a good committee charter.

Where the clinical protocol outlines clinical trial operations and conduct details, the charter does the same to guide the operations and actions of the associated DMC and/or EAC supporting the trial. This blog looks at the key elements of a good charter and explores why these details are critically important to the successful completion of the research.

Find out what DMCs and EACs do and the value they add for clinical research in our blog “DMC vs EAC: What’s the Difference“

A Note on the Regulatory Term “Charter”

In this blog, and in practice, we talk about a “charter” because that is the term the Food and Drug Administration (FDA) uses in its 2006 guidance on data monitoring committees, which governs how DMC and EACs operate. However, the charter document is also seen as an operating plan, operations manual, or similar instructions document describing how the DMC or EAC will independently oversee and assess the research as it is carried out.

Also, keep in mind, both FDA and European Medicines Agency (EMA) consider the charter to have the same level of importance as the clinical trial protocol itself. They can ask for the charter at any time, and they frequently do.

Why Have a Charter?

A charter is an important document required by the regulators, ranking right up there alongside the clinical protocol. To quote FDA, charters are required and are considered an essential document reviewable by the agency:

“Such charters are important for the same reason that study protocols and analytical plans are important—they document that procedures were prespecified and thereby reduce concerns that operations inappropriately influenced by interim data could bias the trial results and interpretation. … FDA may request that the sponsor submit the charter to FDA well in advance of the performance of any interim analyses, ideally before the initiation of the trial” FDA guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees,” section 4.3

EMA has similar language in its 2005 guidance on data monitoring committees.

When to Complete a Charter?

DMC and EAC must be set up and operational prior to the protocol initiating, and a key part of the setup process is formulating the charter.

“A DMC [or EAC] has to be fully functional before enrollment into the study starts to enable it to respond to any safety signal.” EMA guidance “Guideline on Data Monitoring Committees,” section 4 (EAC reference added for context)

FDA’s guidance gives a bit more wiggle room than EMA’s, saying the DMC or EAC must be set up and operational prior to when the committee performs its analysis. However, keep in mind, the FDA also indicates they might ask for the charter as part of their protocol review under the investigational new drug (IND) or investigational device exemption (IDE) requirements.

You do not want to be caught flat-footed during a meeting with the regulator and not have a finalized charter in hand.

What Goes into a Charter?

The charter is the detailed operating plan for how your DMC or EAC will review and oversee the trial. It is the instruction manual, trial guide, statement of work, and blueprint all wrapped into one.

Without a detailed and well-defined charter, the committee may not know exactly what their review scope entails. Likewise, the sponsor may not know which events or what datasets to evaluate, along with the basis and framework for that evaluation.

The following is a partial list of information typically found in a charter:

  • Detailed description of the committee’s responsibilities for the specific study (e.g., what events will be adjudicated, what statistical data will be seen, etc.)
  • List of committee members, including their qualifications
  • Declaration of any possible committee member conflicts of interest
  • Description of communication procedures, including data flow between the sponsor and the committee and procedures for interacting with the sponsor and other relevant parties
  • Responsibilities, timelines, and detailed description of how information will be formatted (e.g., tables, listings, and graphs for DMC; images, information, and Digital Imaging and Communications in Medicine [DICOM] standard for EAC) for the committee’s assessment, including methodological aspects of the review
  • Frequency and format of committee meetings (open and closed meetings)
  • Stopping rules, so the DMC is aware of the threshold for adverse events and can make a recommendation within the parameters that is agreed upon
  • Documentation of the committee meetings (open and closed meetings)

At Advarra, we start each project with a template charter. We work collaboratively with the sponsor or contract research organization (CRO) to ensure all necessary areas are covered (in keeping with regulatory guidance), providing sufficient details in the charter so everyone knows the plan and execution process.

Of course, just like clinical trial protocols, charters can be updated and amended during the conduct of the trial as new information becomes available or additional adjudication events need to be included.

Value of Collaboration

One area many folks overlook is the importance of sincere collaboration when developing the DMC and EAC charters. It is critical the trusted third party who will administer your DMC or EAC takes time to listen, designing the charter to fit the protocol objectives and endpoints while also protecting participants and the safety and efficacy measurements.

Developing the charter is also a good time for the DMC and EAC expert medical and clinical research professionals to offer the sponsor suggestions for potentially incorporating more efficient or meaningful endpoints and measurements into the protocol. DMCs and EACs are there to provide unbiased independent oversight; they are also designed specifically to provide the sponsor with advice and guidance.

A Solid Charter: More Than Just a Good Idea

Anyone involved with clinical research for any period of time knows the process of conducting a clinical trial requires a lot of planning, protocols, operating procedures, and charters to map out what will happen, who will do what and when, and the expected outcomes and results. Without a solid DMC or EAC charter document to map out the details, potential chaos might ensue. Not only is it necessary, but regulatory agencies also mandate charters.

It’s best to work with a trusted third party willing and eager to collaborate with you on DMC and EAC charter development, which will help move your research forward in a positive and timely manner.

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