In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.
In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.
There are many things to consider when implementing a clinical research training program for your staff.
While there are no standard requirements for training, guidelines outlined in the International Conference on Harmonisation (ICH) and the US Code of Federal Regulations state that all monitors should be appropriately trained and have the scientific and/or clinical knowledge to monitor the trial adequately. Your team likely has individuals in several locations with a wide range of experience, which can make it difficult to find something that works for everyone.
Does the thought of a BIMO inspection make you break into a cold sweat?
It’s worth remembering that although BIMO FDA inspections might feel like a pop quiz, this is one test the FDA wants you to pass. That’s why the FDA provides detailed guidance on what its investigators will review, similar to a study guide.
To prepare your site to pass, take time to review our BIMO FDA inspection cheat sheet.
Topics: BIMO FDA Inspection
The Bioresearch Monitoring (BIMO) FDA inspections are an important part of the preapproval process, designed to assure the quality and integrity of study data and adequate protection of the rights and welfare of human subjects. While a BIMO inspection may feel like a pop quiz, the FDA’s goal isn’t for sponsors to fail, but to equip them to pass. By taking a proactive approach to training and preparing, study sponsors can help their site coordinators greet inspectors with confidence. Here’s a quick refresher on BIMO FDA inspections and three steps sponsors can take to prepare.
Topics: BIMO FDA Inspection
No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and even more difficult at times to get answers.
To help with your search, the FDA has created a page that provides copies of e-mail messages (the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program’s email@example.com e-mail account. Inquiries range from 2013 to 2018 and are categorized by the following inquiry subjects:
Traditionally, a clinical research coordinator works on site during a clinical trial, gathering and synthesizing information, organizing data and managing processes. However, the need for research coordinators may be outpacing availability at many research sites. There is a growing need for research that includes global populations and studies that explore devices after they’re released, in addition to the research required before devices receive approval.
Topics: remote research coordinators
We speak with a number of sponsors who are seeking support from a contract research organization (CRO) to help them with their medical device clinical trial. Often these sponsors are also talking with larger CROs, because they feel they can meet their needs better, having the depth and expertise to help them with their global clinical trial.
There are often many reasons sponsors gravitate to larger CROs. It can be name recognition, strong therapeutic experience, a global footprint or many other factors. But bigger isn’t necessarily better.
Topics: Medical Device CRO
In September of 2019 revisions of the Guidance for Industry and Food and Drug Administration (FDA) Staff: Humanitarian Use Device (HUD) Designations and the Guidance for Industry and FDA Staff: Humanitarian Device Exemption (HDE) Program were released. These guidelines were designed to assist the applicants in preparing their submissions of a HUD and HDE, in addition to the FDA reviewers in their evaluation and analysis. While new revisions of the guidelines were released, applicants should still be encouraged to follow the FDA regulations 21 CFR 814, Subpart H – Humanitarian Use Devices when submitting for HUD and/or HDE approval.
The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years, citing concerns that the world will lose access to the EU’s $125 million medical device market.
Medical devices are part of a multi-billion dollar industry that continues to rapidly grow due to technological advances. As a consequence, medical devices have been a hot topic in the mainstream media with coverage in the documentary “The Bleeding Edge” on Netflix and a piece by John Oliver on HBO’s “Last Week Tonight”. In these pieces, the shortcomings of the medical device regulation process in the United States are the focus. And this has sparked some great discussion among medical device clinical professionals and the public alike. However, understanding the medical device regulation process is paramount in order to strive for continuous improvement, updated regulations, and being informed both as a clinical professional and as a patient.
Data integrity is a fundamental requirement of medical research and laboratory experimentation. All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis. As researchers, it is our responsibility to make sure the study is conducted ethically and honestly. The results of the study are used to justify the effectiveness of a procedure, medical device or pharmaceutical. The goal is to improve the overall health and welfare of humans. Lack of data integrity could prove to be a disaster as something originally thought to be safe could cause unexpected pain or death.
The Poly Implant Prothese (PIP) Breast Implant Scandal is one of the most significant patient protection failures in the history of clinical research.
As traumatic as it was for the patients involved, it has also been credited in part for triggering significant regulatory changes in the European Union—including the new EU MDR requirements.
Here's a look back at what happened and how the regulatory landscape in Europe has changed as a result.
The new EU Medical Device Regulation (MDR) and the In vitro Device Regulation (IVDR) are expected to have a far-reaching impact for device manufacturers doing business in Europe.
Topics: EU Regulatory System
On July 31, 2019 the Association of Clinical Research Professionals (ACRP) will be hosting a webinar titled, “Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance”. Michael Marotta and Bradley Lieberman from IMARC Research, Inc. will be the speakers.
My motivations for going to professional conferences usually revolve around staying abreast of new information relevant to my field, networking with others, and earning CEUs. I’ve never gone to a professional conference expecting to be emotionally moved in a giant way, but that’s exactly what happened at an ACRP meeting about 10 years ago when I attended the keynote address given by Eva Mozes Kor, one of the “Mengele Twins” on whom horrific medical experiments were conducted at the Aushwitz concentration camp during WWII. I vividly recall Kor’s strength as she marched us all through her experiences which started when she was only 10 years old. Only 10 years old. Let that sink in.
Each year, the FDA publishes its Bioresearch Monitoring (BIMO) metric findings to provide insight on audit trends and significant violations. The BIMO program’s inspectional data includes Clinical Investigative Sites, Institutional Review Boards (IRBs), Sponsors/Monitors, Contract Research Organizations CROs), Bioequivalence, and Good Laboratory Practice Audits.
As we have done in past years, IMARC examined the warning letters posted on the FDA’s website to compile the top findings from BIMO inspections. This year, we are reflecting on the top findings of previous years and discussing trends seen in 2018.
Although there are no formal requirements for clinical research training, it's an important step to conducting studies in accordance with federal regulations.
Everyone involved in a clinical trial—from the sponsor and principal investigator to research coordinators and monitors—must have a fundamental understanding of these regulations so they can address concerns that will inevitably arise during the study.
To guide researchers through the complex maze of regulations, IMARC developed clinical research training known as The FAIR Shake™ program.
Here's a closer look at what's covered in The FAIR Shake and how to apply it to your next trial.
There is no way to foreshadow a successful outcome of a clinical research trial; however, utilizing FDA guidance and recognizing common causes of an “off-track” study may help with early identification and correction of any necessary study clean-up.
Biomarker testing for cancer assists with early detection and helps physicians monitor treatment.
Recent advances in this area—including liquid biopsies and breath tests—could lead to faster, less invasive cancer screening, as well as more personalized and precise treatment.
Here are a few of the most promising developments.
Topics: medical device trends
On April 11, 2019 a memo was released from the Office of Management and Budget (OMB) stating that United States agencies, which include the Food and Drug Administration, rules and guidances must go to the OMB’s Office of Information and Regulatory Affairs for review beginning on May 11, 2019.
The OMB will be reviewing the agencies regulations and guidances to determine whether they are classified as “minor” or “major”. Previously, each agency was responsible for determining on its own whether the proposed new rule should be classified as major based on reviewing the CRA criteria, which is listed below.
Since the FDA approved the first robotic surgery system in 2000, robotic surgery has been extending its reach to a variety of specialty areas, including orthopedics.
Five of the world’s 10 largest orthopedic device companies have introduced or acquired robot-assisted surgical platforms within the past year. These systems show great promise to increase precision, reduce recovery time and reduce readmissions.
However, they also raise some important concerns.
Here’s a closer look at how robotic surgery is being used in orthopedics, its outcomes so far and the regulatory outlook.
Topics: medical device trends
A new wound care device can help patients heal faster by detecting potentially harmful bacteria in wounds, allowing for more targeted treatment.
The MolecuLight i:X is a noninvasive, handheld fluorescent imaging device that emits a violet light, illuminating bacteria not visible to the naked eye.
This can improve wound care at every stage, from assessment and cleaning to debridement and treatment.
Here’s a closer look at how it works and why it represents a significant advancement in wound care.
Topics: Wound Care
Approximately 30,000 people suffer from ruptured brain aneurysms every year in the United States, and about 40 percent of them die as a result, according to the Brain Aneurysm Foundation.
Neurovascular stents are commonly used to treat unruptured brain aneurysms. However, the FDA last year issued guidance to healthcare providers about the risks of using neurovascular stents for stent-assisted coiling, warning that the risks of this treatment may outweigh the benefits for many patients.
The FDA recently approved a medical device designed to treat brain aneurysms by restricting and diverting blood away from the aneurysm, preventing it from growing and rupturing.
Here’s a closer look at how it works and how new treatments like this one could transform the way we treat brain aneurysms.
On Tuesday, April 23, 2019, the World Health Organization (WHO) announced the launch of a vaccine pilot for malaria in the country of Malawi. Malawi is the first of three African countries, including Ghana and Kenya, which will introduce the vaccine known as RTS,S to children of up to two years of age. Each year, malaria kills 435,000 people worldwide, the majority of them being African children. Additionally, according to the WHO’s press release for the vaccine, the disease claims the life of one child every two minutes.
Recent advancements in transcatheter mitral valve replacement may make heart surgery less invasive, improving outcomes and reducing recovery time for patients.
This approach has the potential to save lives while reducing recovery time and readmissions. Here’s a closer look at how new medical devices could transform transcatheter mitral valve replacement (TMVR) and why these advancements are so exciting for both patients and medical professionals.
Topics: Cardiovascular Clinical Trials
Making sense of the many clinical research trial acronyms sometimes feels like swimming in alphabet soup.
After you've been in the field for some time, using these abbreviations often becomes second nature. But for those who are new to this industry, understanding these clinical research acronyms can seem daunting.
If you need help decoding them, we're here to help. Here are 30 acronyms commonly used in clinical research and what they mean.
Following an FDA inspection, a clinical research site may be issued an FDA Form 483 or a warning letter.
The Form 483 and FDA Warning Letter both serve a similar purpose—to inform sponsors and principal investigators of issues requiring corrective action—but there are some important differences. A Form 483 is less formal but can escalate to a warning letter in the same way a tornado watch becomes a more serious warning.
Read on to learn the differences between Form 483s and FDA Warning Letters, as well as potential changes on the horizon.
Auditing brings an independent, quality assurance perspective to the clinical research landscape. Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Auditors leverage extensive training and experience to help ensure subject safety, data integrity, and protocol and regulatory compliance.
The National Research Act of 1974 set the stage for several important systems of checks and balances in clinical research.
It led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, as well as the Belmont Report and Institutional Review Boards (IRBs).
Here's a closer look at this important milestone in the history of clinical research.
The Nuremberg Code is one of the most influential documents in the history of clinical research.
Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects.
We'll take a closer look at its origins, its guidelines and its enduring impact.
The annual ACRP meeting will be held April 12th – 15th, 2019 at the Nashville Music City Center in Nashville, TN. This meeting brings together clinical research personnel from various backgrounds and provides them with the opportunity to share their expertise as well as obtain knowledge across the clinical research landscape. IMARC will be presenting on Sunday, April 14th, from 3:15 – 4:15 on identifying, documenting, and implementing corrective action plans to improve site compliance from a CRO perspective.
With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials.
During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels and banning menthol in cigarettes. He also oversaw the approval of a record number of new medicines, generic drugs and medical devices.
Yet his departure leaves many questions unanswered, especially those that impact the medical device industry.
Here are just a few of them.
Topics: FDA Approval
ood Clinical Practice (GCP) is a foundation for all clinical research, driven by a desire to ensure everyone who participates in studies is given the protection they deserve. The fundamental principles of GCP have not changed since they were introduced more than 50 years ago. However, as the use of technology in clinical research has evolved to include electronic signatures, records and more, there are new considerations.
Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns.
Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research.
Topics: medical device trends
The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death.
It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm.
These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients.
Topics: History of Clinical Research
The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits.
In fact, it’s the reason IMARC Research exists—and why we're proud to be a partner in compliance for so many medical device companies.
Topics: History of Clinical Research
Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.
Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.
The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection.
In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent.
Topics: History of Clinical Research
With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research.
At IMARC Research, we take pride in innovation. We’re constantly monitoring medical device trends and regulatory updates to determine how they might apply to the clinical research teams who enlist our oversight.
Topics: Medical Devices
The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research. The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds. FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history…It’s not business as usual at FDA. Many key functions aren’t getting done”. Approximately 40% of FDA employees have been furloughed since December 22nd due to the shutdown. The reduced staff at the FDA has been allowed to continue performing specific duties associated with the regulation of clinical research using funding generated from carry-over user fee balances that were paid in 2018. As part of the review process for new medical device registration applications, the FDA charges what is known as Medical Device User Fees . Each type of FDA submission has an accompanying fee that must be paid by medical device companies in order for an application to be reviewed, such as $10,953 for a 510(k), $11,275 for an Annual Report, or $322,147 for a Premarket Approval Application (PMA). Similarly, under the Prescription Drug User Fee Act (PDUFA), user fees are charged for the review and approval of new pharmaceuticals, such as $2,588,478 for a new drug application when clinical data is required. While the FDA has been able to continue to carry out existing reviews that were funded during fiscal year 2018, this cannot serve as a long term solution as these funds are finite. The FDA Commissioner has already cautioned that agency funds from PDUFA user fees may run dry within a month’s time and medical device user fees may be close behind with only two-three months of funding remaining. Below are additional impacts related to the shutdown.
Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since the 1976 Medical Device Amendments will undergo some much-needed updates in the near future to adapt to the ever-evolving medical device landscape. The FDA has already taken steps this past year to begin the transformation process, including the release of a draft guidance regarding the abbreviated 510(k) program. Additionally, the agency recently shared a “performance report” describing various measures implemented in the last 10 years to improve the 510(k) pathway, with a spotlight on recent efforts. These actions taken by the FDA include:
Clinical research professionals have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. Proper documentation is of the upmost importance in our work!
The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018. The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.
In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.
When it comes to ensuring compliance, keeping your trial on track and bringing your medicaldevice to market faster, having independent oversight from a strategic partner makes all the difference.
Clinical project management is a logical and often desirable1 career progression for those in CRA roles. While the exact path from CRA to project manager (PM) varies from company to company and person to person, the first step for the budding PM usually involves education. For most, this training comes in the form of a project management course or seminar.
Entering the “home stretch” of a medical device trial is always an exciting time. You can see the finish line in sight. You’ve planned for success, and you’ve run the race well. But before you take your victory lap, you still have a few more hurdles to clear.
Topics: Compliance Partners
As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.
In the daily chaos of running a medical device trial, it's a struggle to keep from dropping the baton.
There are patients to enroll, protocols to follow, vendors and large volumes of data to manage. It’s enough to stress out even the most experienced clinical research professionals!
Take a deep breath. Remember all the work you’ve done to plan your trial before it started. Feel confident in your clinical research team, knowing they have been trained to understand and apply all the necessary regulations.
Then, follow these recommendations to keep your medical device trial running smoothly—and stay compliant.
IMARC Research will be represented at the MAGI Clinical Research Conference 2018 West in San Diego, October 21-24, 2018. The Director of Clinical Support Services, Rachel Silver-Kessler, will hold a work session for sponsors and CROs to share best practices for working with sites, and will present on adverse event reporting in medical device studies. Check out the full conference agenda here.
Conducting a medical device trial is a lot like running a race. It takes a lot of training and preparation before you even get to the starting line.
And the only way to ensure you reach the finish—bringing your medical device to market—is to ensure compliance at every stage in the clinical trial lifecycle.
That starts long before you sign up your first subject.
The planning stage is crucial because it sets expectations for how your team will work together to collect data, monitor results and protect your trial’s subjects.
In this post, the first in a three-part series, we’ll cover five important steps you can take to ensure compliance before you start your medical device trial.
Topics: Compliance Partners
FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”
The FDA’s Bioresearch Monitoring (BIMO) inspection program ensures the protection of the rights, safety and welfare of human subjects during clinical research trials.
The most recent results represent findings from more than 1,300 clinical research audits of clinical investigators, sponsors and IRBs for the 2017 fiscal year.
This whitepaper covers the seven most common ones and how you can avoid them.
Topics: FDA Warning Letters
In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly. The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the device is classified as Class I or II, and if it is non-exempt, a premarket notification (510(k)) will be required for marketing. A 510(k) is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).
Clinical research professionals have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. Proper documentation is of the upmost importance in our work! .
Your trial master file (TMF) tells the story of your entire clinical study, so you want to make sure it’s complete and accurate before the FDA reviews it.
Hiring a third party to review your trial master file is the best way to ensure you’ve checked all the boxes.
However, the cost of a TMF audit can be significant.
Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too.
But a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far?
"The Bleeding Edge," produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in their procedures.
Topics: Medical Device Manufacturers
Training programs should build proficiency in core job skills and be based on a strong regulatory foundation. Course curriculum should include practicum/on-the job training as well as exposure to emerging topics such as future trends in clinical data and patient centricity.
In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements of the Institutional Review Board (IRB) / Ethics Committee (EC), and all applicable regulations.
In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now almost five years later, many sites and Sponsors have explored and implemented the electronic filing capability.
While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset—the acceptance by all that, regardless of one's title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.
In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits.
We have had many conversations with sponsors regarding their needs for monitoring support services. It is clear that while many sponsors consider the outsourcing of their monitoring needs to a CRO, they have many concerns that they have shared with us.
As many of us monitors are aware, there is high turnover in the research industry and clinical sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.
Reviewing a medical chart can be a daunting task for anyone on the research team. However, ensuring proper data extraction and source data verification is paramount to ensuring data integrity and subject safety in your clinical trial.
While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset. The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.
Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and more accurately a trial is performed, the faster the new medication or clinical product can be introduced to the market and begins helping the community.
You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings of time and money compared with hosting an in-person audit. So now you may be asking:
Anyone who’s ever prepared for an FDA Inspection of their clinical study has undoubtedly spent hundreds of hours sifting through all of the essential study documentation that makes up the Trial Master File (TMF) in an effort to make sure every single document needed to tell the study’s “story” is there, is accurate, and is complete. Sometimes this is handled internally and sometimes companies hire external contractors to assist. Either way, there can be a huge price tag associated with this. At two recent TMF audits, I found myself asking the following questions:
In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough to explain?
Concomitant medications (con-meds) are any prescription or over-the-counter drugs and supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record. This can be an extremely difficult task as it relies on the honest and accurate reporting by subjects as well as detailed review of medical records. It is not enough to simply submit the name of a medication, as most con-med reports typically require dosage, frequency, and duration of usage. Often, multiple con-med entries will need to be created in the study record for the same medication if the dosage changes or if the subject stops and restarts the medication. This can potentially lead to dozens or more errors of data point entries for a single study subject. So why are con-meds so important in research trials and how can researchers ensure that con-meds are being accurately reported?
The annual ACRP meeting will be held this upcoming weekend (27-30 April 2018) at the Gaylord National Resort and Convention Center in National Harbor, Maryland. This meeting presents an opportunity for clinical research professionals to meet and listen to/discuss the latest in clinical research. At this meeting, IMARC will be presenting on Saturday, 27 April 2018, from 11:30-12:30 on the topic of adverse event (AE) reporting for medical device clinical trials.
When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program.
On May 25, 2018 the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how does this new regulation affect personal data collected during a clinical trial and what do Sponsors and Contract Research Organizations (CROs) need to do to ensure compliance? Here we aim to address the highlights of the GDPR and its implications on clinical research.
In today’s competitive business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits.
A well-controlled clinical trial is much like a well controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet.” In the 21 CFR 314.126, the FDA lays out regulations as to what makes an “Adequate and Well-Controlled study” as one that has:
This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees, and help attendees understand the differences between Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and Medical Monitors. Professionals at research sponsors, CROs, sites, and IRBs will learn when each type of safety oversight is recommended and how to provide effective, efficient safety monitoring. Participants will also hear from a DSMB Chair about their experiences and the important impact of safety groups to research studies.
Clinical research professionals need to keep up to date with changes to the industry to ensure their studies remain compliant and human subjects are protected as research becomes more complex. Several important changes have taken place over recent years, including greater emphasis on risk-based and quality-focused thinking, as well as the increased use of electronic technologies to accomplish research activities.
You may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances.
Research sponsors and sites know the importance of implementing Quality Assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into Data Safety Monitoring Boards, Clinical Events Committees, and Medical Monitoring? Take a look at these four tips:
A safety monitoring group may be called many different things— a data monitoring committee, a data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study risks.
What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)? The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA). The site in question was part of that clinical trial but now the study and enrollment goal has been met and the both the site and study are closed.
Outsourcing clinical support services is a common practice, but can be a challenging process. Over the years, we have had many conversations with sponsors regarding their need for clinical support services and they have shared many of the challenges they have faced.
IMARC Research has moved to a new office in the Minneapolis area, in Minnetonka. The office will continue to be managed by Jim Moat, Director of Clinical Monitoring Services.
Jim is a Certified Clinical Research Associate with over 26 years of experience in medical device product development, having managed all phases of clinical studies – from pre-market strategy to post-market surveillance.
Topics: IMARC Research
Writing great monitoring reports is not just about writing the report. It requires an in depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template, and of course, the regulations. Attention to visit preparation, clear notetaking during the visit, and prompt, clear report writing pays off in delivering a high-quality document. It is a difficult skill to master, but one that is rewarding, especially when faced with a regulatory inspection.
Having a well-trained clinical research staff is vital to ensuring compliance and securing regulatory approval. Providing training solutions for continuous improvement, understanding industry best practices and new clinical developments – is vitally important to employees. Yet many medical device companies face challenges on how best to provide high-quality training programs for their clinical departments.
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on 06 September 2017. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field. An interoperable medical device is one with the ability to exchange and use information with another medical or non-medical product, system, or device. An electronic interface is a medium by which these systems can communicate. This type of communication or exchange between systems and devices may include transmission and/or reception, storing, analyzing, or interpreting data. Medical device manufacturers are also designing interoperable devices to perform more advanced types of data exchange such as one device issuing commands or having control over another device(s).
On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
Using this technique will give you confidence in resolving potential compliance issues and bridge the gap between knowledge and application. There’s a reason our FAIR Shake guide is one of our most-requested resources.
This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.