FDA Keeping Eye on Online Drug, Device Benefit Promises


Mitchell Parish, JD, RAC, CIP, senior regulatory attorney, Quorum IRB

The U.S. Food and Drug Administration (FDA) understands you can’t control absolutely everything posted about your drug or device as part of your effort to solicit new clinical trial subjects, but you’d better keep an eye on promises made regarding how much your product can benefit people. That’s the warning from Mitchell Parish, JD, RAC, CIP, a senior regulatory attorney with Quorum IRB.

FDA also wants you to be proactive when it comes to informed consent and recruitment of potential trial subject, Parish adds. That’s tricky when you go online to find new folks via Facebook and the like. It gets even more troublesome when promises are made or implied that your drug and device can do all sorts of things that don’t strictly adhere to the trial protocol.

It’s critical to have in place a plan to monitor and control, to a realistic extent possible, online chatter about your drug or device, Parish says. For example, FDA will examine whether you encouraged, directly or inadvertently, a comment from someone extolling off-label virtues of the product. It’s also important to remember that product claims require institutional review board review and approval, yet objective information isn’t under the same scrutiny. It’s important to know the difference and have a plan in place with defensible definitions of each, says Parish.


Owen Garrick, president and chief operating officer, Bridge Clinical Research

Ironically, one of online recruitment’s biggest strengths is also one of its most glaring weaknesses, says Owen Garrick, president and chief operating officer with Bridge Clinical Research. “You see patients and caregivers flocking to social media sites” and willingly sharing information and health tips, he notes. That’s great, but according to Garrick, it also raises thorny questions over how to effectively track promises of efficacy and impact for a drug and device.

“People have become so comfortable sharing that kind of information,” Garrick says. The trouble often begins when patients praise what the drug has done for them personally.

Garrick and Parish will be part of a panel session, Social Media in Clinical Trial Patient Recruitment, at the ACRP 2016 Meeting & Expo in Atlanta, Ga.

FDA: Risk-Based Monitoring Remains Fuzzy Concept in Clinical Trials Industry


David Burrow, acting deputy director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research

Risk-based monitoring (RBM) has become a confusing buzzword that too often means different things to different people. That’s a potentially dangerous situation, says David Burrow, acting deputy director of the Office of Compliance for the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). “RBM should be one part of a larger system that starts with risk assessment before even putting together a study protocol,” he warns.

RBM must be factored in when deciding what types of data will be collected and what needs to be in a protocol. The protocol, in turn, becomes a “blueprint for quality” that then allows trials to use RBM in a narrowly targeted way that is thought through from the outset—not as something grafted onto an already ongoing trial. Trial personnel must understand the entire lifecycle of the trial from the very beginning, Burrow stresses.

Before RBM can leap forward as a ubiquitous tool, FDA needs to see industry examples of a complete lifecycle trial using it. That’s a bit of a catch-22, Burrow concedes, because that complete lifecycle can take several years. “We haven’t yet seen one with RBM fully in place from day one,” he says. Sites have been using RBM principals in the intermediate portion of trial development, but that’s not enough for the FDA to weigh in conclusively.

“It’s appropriate to have a continued discussion with ACRP members” to swap RBM case studies, lessons learned, and best practices, Burrow says. He will speak at ACRP’s upcoming Meeting & Expo in Atlanta, Ga., offering advice on how best to handle an overall FDA inspection, and encouraging attendees to help the agency further advance its RBM policies by sharing their experiences with RBM on the front lines of clinical trials.

Learn more about Burrow’s ACRP 2016 Meeting & Expo sessions:

Is Generation Gap Slowing mHealth Adoption in Clinical Research?

Generation Xers and Millennials look at technology differently, says Jeri Burr, a program director at the University of Utah. “These generational differences affect everyone,” she notes.


Noel Chandler, CEO, Mosio

Take a look at mHealth adoption in the clinical trial industry. While hesitant to lay too much blame on a tech generation gap, mHealth proponent Noel Chandler, CEO of two-way text messaging software firm Mosio, acknowledges adoption can be a tough sell to the decision-makers closer to the top of the organizational pyramid. His advice to a research coordinator pitching its usage? Focus on a single, easy-to-grasp benefit.

Too often, excited advocates will throw a dozen potential benefits at a wary executive. Instead, Chandler suggests picking something like appointment reminders. Surveys show it typically takes three days for someone to respond to voicemail. Nearly a quarter don’t respond at all. However, a vast majority of trial participants respond within 30 minutes to two-way text appointment follow-ups. Appointment follow-ups can also be handled by far fewer staff, he adds. “Those are pretty clear metrics” likely to grab an executive’s attention, Chandler says.


Jeri Burr, Program Director, University of Utah

Millenials have grown up with technology GenXers didn’t meet until they were in their 30s or later, Burr notes. Both sides, as it were, need to educate the other. Millennials have to show the value, while GenXers have to remind their younger colleagues that they don’t have to lug their laptops or tablets around with them wherever they go. “I go to meetings where the younger employees have their laptops out on the table texting and e-mailing during a discussion,” she says. The younger set aren’t being rude, she stresses. It’s just that they’ve grown up operating that way.

Chandler is encouraged that text messaging is seeing its fastest adoption rate among those aged 45–65. “They’re getting into it,” he says.

The tech generation gap shows signs of closing up. However, it’s up to members on both sides to explore better ways to make their own two-way interactions more productive.

Burr will present her popular session, Four Generations, One Workplace, at the ACRP 2016 Meeting & Expo.

Chandler will present a first-time session on mobile technologies at the ACRP 2016 Meeting & Expo, Mobile Technologies in Patient Engagement and Retention.

Former FDA Auditor: PIs Primary Target When Agency Comes Calling

Principal Investigators (PIs) need to surround themselves with a good team when a Food and Drug Administration (FDA) inspector comes calling, but they risk serious problems if they forget the buck stops with them. That’s the warning from former auditor that prepared sites for FDA inspections, Chavon Steele, now a senior clinical trial monitor for Medtronic.


Chavon Steele, senior clinical trial monitor for Medtronic and former FDA inspector

PIs seemed ill at-ease and otherwise under prepared at about half of her onsite situations where she audited or prepared for inspections, she says. It’s all the more worrisome given the fact that the PI nearly always knew in advance which study Steele was coming to discuss. Their mistake: “They clearly relied too much on their study coordinators when I’d interview them.” PI’s don’t need to be an expert in minutiae, but they’d better have a demonstrative top-line knowledge of the trial in questions, she emphasizes.

Steele believes the culprit is more often over work or a failure to realize the importance of their role in the inspection rather than an actual need to defend any questionable trial work. That said, an ill-prepared PI made auditor Steele cautious – and that can have a negative effect on the sponsor, too. It could rattle sponsors and jeopardize future job prospects by putting the wrong kind of spotlight on how a site conducts itself. Sponsors “might decide not to use that site in the future if it gets that kind of reputation,” according to Steele.

Internal communications are also a key, she says. One of the first things she’d look for on-site was how well and how often PIs shared information with others. She wasn’t expecting a one-size-fits all approach. She was generally satisfied if she saw evidence of weekly in-person meetings or regular eblasts with pertinent trial updates.

Another audit/inspection focus or concern is around documentation of PI oversight. For example, keep a watchful eye on time lags between when a lab result was available and when the PI signed off. “If it took three weeks it suggested to me there might be some issue” and the FDA inspector needed to investigate. It’s important to tighten those timelines or, if you know you’ve got some gaps, be prepared to explain the reasons to the inspector.

Steele will be sharing more observations and compliance tips during her ACRP 2016 Meeting & Expo session, So You Have Been Chosen for an FDA Inspection: Guidance from a Former Auditor on How to Prepare, Host and Follow Up for a Site Inspection.

3 Keys to Building a Top-Notch Clinical Trial Staff


Jim Kremidas, ACRP Executive Director

Staffing issues are top of mind among leadership at clinical research organizations around the world. Look no further than the ongoing bidding war for monitors/CRAs at sponsors and CROs for proof that top-quality clinical trials staff are a hot commodity.

Building a high-quality staff at any clinical research organization – be it a sponsor, CRO, site, or academic research center – requires focus in three key areas: staff acquisition; staff development; and staff retention.

Staff Acquisition

Recruiting and hiring the right employees can be a timely process, but it’s the critical first step in building quality teams. Getting it right results in efficiency and immediate productivity. Getting it wrong results in sunken costs and repeat processes.

One way to screen talent and tailor focus toward top-quality professionals is to seek candidates with professional certifications that speak to an individual’s commitment and provide an independently verified level of competence. Another is to engage professional recruiting services that can build a qualified talent pipeline for interviews while creating efficiencies in the recruitment process.

As my boss told me when I moved into my very first management position “hire well or manage like hell.” Truer words have never been spoken.

Staff Development

A lack of professional development support is an oft-cited reason employees seek opportunities elsewhere. Successful organizations develop existing talent by providing opportunities for professional growth and development.

According to the Great Places to Work Institute, employees at the 100 best places to work are provided 66 hours per year of training, with 40% of those hours dedicated to employee growth.

Employers can support an employee’s professional development in several ways, including providing access to, or financial support for, training programs, meetings and conferences, certifications, and membership in professional organizations.

Staff Retention

Retaining your best employees and leveraging their institutional knowledge is critical to any organization’s success. What’s more, the cost of a new employee is significantly greater than that of an existing team member.

From the Society of Human Resource Management:

“Employee departures costs a company time, money, and other resources. Research suggests that direct replacement costs can reach as high as 50% to 60% of an employee’s annual salary, with total costs associated with turnover ranging from 90% to 200% of annual salary.”

Employers can retain their best talent in myriad ways, including fostering ongoing professional development and career growth through by supporting training, certification, and membership in professional membership organizations and societies such as the Association of Clinical Research Professionals (ACRP).

ACRP is a non-profit organization with more 40 years’ experience supporting clinical research professionals and helping clinical research organizations accomplish staff acquisition, development, and retention goals.

Visit the ACRP team February 23-25 at the SCOPE Summit for Clinical Ops Executives in Miami, Florida, to learn more about how we can help your organization build a top-notch clinical trial staff. We will be in Booth 707. See you in Miami!

Rookie Investigators Underestimate Seriousness of Signing FDA 1572s

Too many green principal investigators (PIs) blithely sign the U.S. Food and Drug Administration (FDA)-demanded Statement of Investigator (Form 1572) and run the risk of falling into serious trial deviations or even potential legal issues, warns Randall Stoltz, medical director with the Covance Clinical Research Unit in Evansville, Ind.


Randall Stoltz, CPI, Medical Director, Covance Clinical Research Unit in Evansville, Ind.

“You have to ask what you are committing yourself too,” Stoltz says. It is not uncommon at some sites that a site director or coordinator casually hands the 1572 to the investigator, and “They’ll just say there’s something for you to sign” and treat it more like a formality, Stoltz adds.

PIs face serious consequences if they don’t take a hard look at the commitments of the 1572 that they are agreeing to when signing. Stoltz advocates knowing in advance what should be in place to run an effective, compliant trial. For example, do you understand what constitutes a regulatory file? What constitutes a serious adverse event and how to deal with it? What the sponsor/monitor expectations will be before, during, and after the trial’s initiation, conduct, and follow-up periods?

The form spells out what the FDA expects, including PI requirements such as that he/she will:

  • Conduct the study in accordance with the relevant, current protocol, and will only make changes [after?] notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
  • Personally conduct or supervise any investigations.
  • Maintain accurate and adequate records in accordance with 21 CFR Part 312.62 and 312.68 in the Code of Federal Regulations.
  • Ensure that all associates, colleagues, and employees assisting in the conduct of any study are informed about their obligations in meeting their relevant requirements.

This is just a partial list of the daunting tasks expected of a PI in a trial, and not something to be taken lightly, stresses Stoltz, who has served as the PI in more than 500 trials. He adds that he’s seen physicians looking into adding clinical trials into their practice as “an easy thing to do and a way to make easy extra money.” That’s a grave mistake, if they are not going to take their obligations regarding ethical, responsible clinical research seriously.

Stoltz will address these and other issues at his ACRP 2016 Meeting & Expo session, So, You Want to Be an Investigator: The Other Side of the Coin.

Career Tip: Invest in Your Continued Education


Carla G. Perna, BS, CCRP

Carla G. Perna, BS, CCRP, recently reflected on her career and lessons learned as she advanced from research assistant to program director, and on the importance of staying on your toes.

Q: What advice do you have for clinical research professionals on how to advance their careers?

A: Get your degree; get certified! Pick a focus and stay on your toes. The research landscape is in perpetual motion; continued education is important to stay up to date. Use your networks and attend conferences whenever possible.

Q: As you think about the future generation of clinical research professionals, what are some of your most important lessons learned?

A: Investing in your continued education is the most important thing you can do for yourself. The time and commitment can be challenging, but the rewards are immeasurable. Be prepared for a changing environment. Successful clinical research professionals must be open minded and flexible; we must be steadfast in assuring that our research ethics and principles are not challenged. Clinical research is a very rewarding career. I am so grateful to go to work every day with a purpose. Our patients are the heroes of future generations.

Perna has risen to program director for budget, regulatory, and finance matters with the University of Alabama’s Comprehensive Cancer Center’s Clinical Studies Unit. She was interviewed by Beth D. Harper, MBA, president of Clinical Performance Partners and a member of the ACRP Editorial Advisory Board.

Read more from Perna’s interview in the June 2015 issue of Clinical Researcher.

Are Your SOPs Ready for Prime Time?

Standard operating procedures (SOPs) are the foundation for any effective clinical research program, experts agree. The U.S. Food and Drug Administration (FDA) agrees, too. It’s one of the most common areas the agency scrutinizes during an inspection. Officially, SOPs are defined by the International Conference on Harmonization (ICH) in its Good Clinical Practice Guidelines (ICH GCP E6) as “detailed, written instructions to achieve uniformity of the performance of a specific function.” Unofficially, it’s not always that simple.

While SOPs have been generally considered the purview of sponsors and CROs, they’re also important for institutional review boards/ethics committees (IRBs/ECs) and Investigators. Sponsors and CROs face distinct regulated tasks and requirements. Some good news: Solid SOPs can help minimize the challenges presented by staff turnover i.e. inconsistent data collection and reporting techniques.  Research relies on repeatable, reliable, accurate data, a breach or compromise in any of those can be catastrophic to the entire clinical research study which can ultimately lead to a rejected product, or worse: approval of a product without fully reported safety information. With strong documents in place, it’s that much easier to bring a new employee up to speed and prevent any problematic operating gaps.


Janet Holwell, Independent Research Consultant

For example, it is critical to have SOPs in place to address document control and informed consent signatures, says independent research consultant Janet Holwell. It’s easy, especially for a new employee, to overlook the requirement to have the subject and the investigator sign the consent form simultaneously. While it’s often an honest mistake, FDA won’t always be forgiving. She also stresses the need for SOPs addressing version control. Headers and footers, and even versions of forms on different color paper, can be part of an SOP that will help guide new and long-time employees, she says.

Grappling with SOPs can be a daunting task.  Which SOPs are required and how they should be written is open to interpretation.  Standard templates and standard SOP topics can help get the ball rolling.

Which SOPs are Required of Sponsors/CROs, IRBs/ECs, and Investigators?

Three common SOP topics that are applicable industry-wide to Sponsors/CROs, IRBs/ECs and Investigators include staff training, safety monitoring, and protection of human subjects to name a few.  The scope of each will differ since each entity has different roles to play in the process of a clinical trial.

More specifically, investigative sites should have additional SOPs in place to support the work performed by site personnel and ensure that the Investigator responsibilities detailed in ICH GCP and Federal Regulations are upheld.  Additional examples include:

  • Handling of essential documents
  • Investigational product management
  • Informed consent process
  • Inspections by regulatory authorities

How Should SOPs be Written?

SOPs should not merely be a duplication of regulations or guidelines.  Rather, they should be instructive to explain how the regulations and guidelines will be followed in a consistent manner.  There’s a fine balancing act required between being too flexible and too rigid.  On the one hand, it is rather pointless to have a very general procedure that does not explain who is responsible for what specific task and when.  But on the other hand, if the procedure is written too strictly, it leads to risks of SOP deviations which is probably worse than not having an SOP in the first place.

A good SOP should clearly identify the scope, be separated into easily identifiable sections, include responsibilities for specific tasks, detailed procedures to perform tasks, and any associated documents/forms/tools to support the work governed by the SOP such as checklists and templates.


imgSOPDownloadGet started today with these free downloads from ACRP:

These resources are from ACRP’s eLearning course, Site Quality Management Tools: SOPs, Metrics, and Training, available for $99 to ACRP Members ($149 for Nonmembers).