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IMARC Blog

Compliance In Focus

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Posted by Holly Whitta on Tue, Sep 27, 2016

Organization: The Master Key to Compliance

While good organizational skills may present a challenge to many of us, allowing disorder to follow us to work is simply a recipe for disaster. Not only can disorganization create for a hectic day, it can also lead to larger problems with industry compliance standards and FDA approvals. Whether your company is involved in drug trials or device studies, poor organization can leave your site more vulnerable to non-compliance if risk-based monitoring is used. It can also create an unpleasant environment during an FDA audit if there are issues with a Sponsor or site’s compliance with ALCOA (attributable, legible, contemporaneous, original, and accurate) guidelines. (Please refer to our ALCOA infographic for more information.)

Topics: ALCOA, Compliance, Organization

Posted by John Lehmann on Thu, Sep 22, 2016

ALCOA - The Best Way to Document Your Work

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

Topics: ALCOA, Checklist

Posted by John Lehmann on Tue, Sep 13, 2016

5 Tips for Meeting the UDI Deadline

The FDA’s Unique Identification program directs that class II device-makers to be compliant with the law by September 24, 2016. Based on this deadline, there is evidence that many manufacturers are unprepared for the next phase of the agency’s UDI rule.

Topics: FDA, UDI Deadline, Linda Sigg

Posted by John Lehmann on Thu, Sep 22, 2016

Site Selection - What to Look For?

Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task for a sponsor. Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen. Choosing the wrong sites could have a detrimental effect on the study including: 

Topics: Sponsors, Site Selection

Posted by Mary Lewis on Wed, Aug 24, 2016

What is the Difference: Auditing vs. Monitoring?

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

Topics: Auditing, Monitoring

Posted by John Lehmann on Thu, Aug 18, 2016

Adding Value to a Study with Safety Monitoring Oversight

Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) and/or a Clinical Events Committee (CEC).

Topics: DSMB, Safety Monitoring

Posted by Lauren Luzar on Wed, Aug 10, 2016

Postmarket Surveillance Under Section 522

The FDA issued the guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” on May 16th, 2016. Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices.

Topics: Section 522, Post Market Surveillance

Posted by John Lehmann on Thu, Aug 04, 2016

Title 21: 1981

When you visit IMARC Research's office, you will notice beautiful artwork on our lobby wall.  The artwork pays homage to key events in the history of clinical research.  We also released an eBook that describes all the images that make up the timeline and we encourage everyone to take advantage of this important information. 

Topics: FDA Regulations, Title 21

Posted by Tracey Tytko on Thu, Aug 25, 2016

FDA Warning Letters: Findings for Clinical Investigators

Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing application. When serious violations are found during a BIMO inspection, a warning letter is issued. These BIMO inspection metrics provide the common findings that are found during these inspections by fiscal year (FY). According to the United States federal government, the FY begins on October 1st of the previous calendar year and ends on September 30th, the year in which it is numbered.

Topics: FDA Warning Letters, FDA, BIMO Program

Posted by John Lehmann on Tue, Jul 26, 2016

GCP - What Does it Mean?

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

Topics: Good Clinical Practice, Infographic, Clinical Research

Posted by John Lehmann on Tue, Jul 19, 2016

The Keys to Choosing the Right CRO

In the past we have written blogs providing criteria for selecting a Contract Research Organization (CRO). When you’re a sponsor or investigator and you are faced with the decision of hiring a CRO, picking the right organization can be difficult. Finding the right fit for your organization requires a well thought out process with many key points to consider.

Topics: Infographic, Regulatory Experience, CRO Selection

Posted by John Lehmann on Tue, Jul 12, 2016

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: Risk Management, FDA, Clinical Research

Posted by Brandy Chittester on Fri, Jul 08, 2016

5 Questions for Coordinators Preparing for a Monitoring Visit

As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:

Topics: Research Coordinators, Clinical Monitors

Posted by John Lehmann on Tue, Jul 05, 2016

New Whitepaper: Elements of a Regulatory Inspection

While inspections of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO Inspections can occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be challenging to predict as the audits are not necessarily triggered by a sponsor regulatory submission.

Topics: IMARC Whitepaper, FDA Inspection, BIMO

Posted by John Lehmann on Tue, Jun 21, 2016

What Makes Good Clinical Research Training?

We have noticed an increase in the demand for training across the clinical research landscape. This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted. Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular part our profession. In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience. But what constitutes “adequate” training? This a question often asked of us by the sponsors and investigators we work with.

Topics: IMARC University, Clinical Research Training

Posted by Mary Lewis on Tue, Jun 14, 2016

Preparing for an FDA Audit

You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit. It is helpful for a site to know what the FDA auditor will use during their review. In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations.

Topics: BIMO Checklist, FDA Audit

Posted by John Lehmann on Thu, Jun 09, 2016

FDA's Device Evaluation Program is Underway

The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center for Devices and Radiological Health (CDRH) strategic priorities report for 2016-2017, establishing a National Evaluation System for medical devices is a priority, however according to the CDHR Director, Dr. Jeffrey Shuren the system may not be ready until fiscal year 2023, if the agency cannot secure funding.

According to an article in The Gray Sheet, it mentioned that Dr. Shuren received assurance from the FDA’s Commissioner, Dr. Robert Califf that the agency will provide the initial funding for a coordinating center that would help build the system. However, the money will only be provided if additional funding is forthcoming from Congress or increased user fees, which are being negotiated in the Medical Device User Fee Act (MDUFA IV).

Topics: CDRH, NEST, National Evaluation System

Posted by Victoria Sawczak on Tue, Jun 07, 2016

The Real Costs of Clinical Research

In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole (Hoiyan) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money offered on a campus flier for participation in the clinical research study to be extremely enticing. Back in Queens, New York, Mr. and Mrs. Wan were unaware of their daughter’s intention to enroll in any study.

Topics: New York Times, Clinical Research, Nicole Wan

Posted by Tracey Tytko on Fri, Jun 03, 2016

Attn: Data Integrity Compromised

After months/years of conducting your clinical trial, you submit a Premarket Approval Application (PMA) to the Food and Drug Administration (FDA) with the expectation that your Class III medical device will be approved. Unexpectedly, you receive a call from the FDA. The FDA requests to inspect one of your sites to ensure that the data is scientifically valid and the welfare of research subjects have been protected. You don’t worry. Later, the FDA issues a Warning Letter revealing serious violations that could jeopardize the validity of the trial and may refuse to approve the application. You then realize, all of this could have been prevented.

Topics: FDA, Clinical Monitoring, Data Integrity

Posted by Tracey Tytko on Tue, May 24, 2016

The World of Digital Health

We are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment options (games, videos, etc.), allows you to check your electronic mail, and interact with family and friends. Other applications that are being developed are now allowing us to track our health and wellness, and even communicate with healthcare providers, remotely. These types of applications are known as either mobile health applications (mHealth) or mobile medical applications (MMAs).

Topics: Mobile Medical Applications, FDA, Digital Health,

Posted by John Lehmann on Wed, May 18, 2016

FDA Outlines MDUFA Proposal Cost

After several months of deliberation, the FDA has put some hard numbers to how much the proposed user fee reauthorization act (MDUFA IV) would cost. The agency has indicated the price tag of the reforms at $500 million over five years on top of the current user fee base. This does not take inflation into account.

The FDA had initially estimated it would cost and extra $456.4 million over five years. However, after more analysis the agency update the estimate according to January 27th meeting minutes.

Topics: MDUFA, FDA

Posted by John Lehmann on Fri, Jun 03, 2016

5 Hurdles to Overcome When Planning a Clinical Trial

The planning stage is critical to the success of any clinical trial. It sets expectations for how your team will work together to collect data, monitor results, protect human subjects and much more.

In effect, it sets the standards for your entire trial, so it’s essential to get it right from the start. However, the planning stage is most often when progress stalls before it even begins. Clinical professionals encounter a number of hurdles that can slow momentum, delay approval or even compromise the integrity of the study if they aren’t addressed.

Here are five of the most common hurdles your team is likely to face when planning a clinical trial and how to overcome them.

Topics: Clinical Research

Posted by Toni Hegyi on Mon, May 23, 2016

The Benefits of Using an Independent CRO to Manage Your DSMB or CEC

Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical Events Committees (CEC) adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not. While it is critical to understand the primary purposes of a DSMB/CEC, you should also look beyond meeting basic requirements in order to be the most confident in your efforts for patient protection and study results.

Topics: CRO, CEC, DSMB

Posted by John Lehmann on Mon, May 23, 2016

Learning to Trust the Process

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

Topics: Case Study, FDA Audit, Trust the Process

Posted by John Lehmann on Mon, May 23, 2016

Good Clinical Practice: From Review to Applications

In clinical research many rules and regulations exist to govern the way research is conducted and to protect those patients who are participating in research. One of the standard principles directing clinical research is Good Clinical Practice. Good clinical practice is more than any one document; rather, it is a collective compilation of many thoughts, ideas and learning moments spanning the globe over.

Good clinical practice is an attitude of credible excellence in research that provides a standard for clinical study design, implementation, conduct and analysis. Furthermore, good clinical practice is a mind-set that is absolutely essential to the protection of patients’ rights and the assurance of data integrity. Many of these lessons stem from some of the tragedies in the history of clinical research which has formed and shaped much of the frame work today.

Topics: Good Clinical Practice, Whitepaper, IMARC Research

Posted by Paul Cobb on Thu, Apr 07, 2016

Enhancing Relationships between Monitors and Research Coordinators

 The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.

How can we ensure that these relationships are optimized?

Topics: Clinical Research, Site Coordinator, Clinical Research Monitor

Posted by Tracey Tytko on Tue, Apr 05, 2016

The Future of the FDA: The Perception of a Clinical Research Associate

There are many stakeholders involved in conducting a clinical trial today; however there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running medical device trials can vary anywhere from securing funding to lacking time and having dedicated study personnel. Another challenge that is faced is the time to market new devices that are ensured to have safety, quality and effectiveness. Although protecting human research subjects is the top of all priorities, can this regulatory pathway be shortened?

Topics: FDA, CDRH, Robert Califf, Clinical Research Associate

Posted by John Lehmann on Fri, Apr 08, 2016

An Infographic: Comparing Drugs and Devices Trials

Several year ago, IMARC Research published a whitepaper outlining the differences between Drug and Medical Device clinical trials.  Since IMARC focuses primarily on medical device trials, we felt it was important to highlight the differences between the two trials.  It has proven to be one of our more popular whitepapers, so we have decided to offer everyone an infographic as a quick reference.

Topics: Drugs vs. Devices, IMARC Research, FDA

Posted by John Lehmann on Wed, Mar 23, 2016

The History of Clinical Research eBook

For clinical research professionals, the protection of human subjects has always been of paramount importance.  Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team.  Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

Topics: History of Clinical Research, eBook, IMARC Research

Posted by John Lehmann on Thu, Mar 24, 2016

In Vitro Diagnostics: The Basics

It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010.  The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a “one-size-fits-all” model.  Furthermore, developments in technology and the scope and precision of some of these devices have led to the evolution of the IVD field and with it, the role the FDA has played in regulating these devices. 

Topics: IVD, FDA, IMARC Research Whitepaper, In Vitro Diagnostics

Posted by John Lehmann on Fri, Jun 03, 2016

Clinical Training: A Blueprint for Success

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. 

Topics: Medical Devices, Clinical Training, Clinical Research Staff

Posted by Paul Cobb on Tue, Mar 08, 2016

Changes to the FDA Routine Inspection Plan: Will This Help FDA?

In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by:

  • Identifying and addressing issues before the FDA finds them.
  • Preparing for Inspections by reviewing the BIMO checklists and knowing what to expect.
  • Proactively addressing compliance concerns through BIMO preparation audits.
  • Verifying that vendors are qualified to do their jobs.
  • Preparing the research team with mock inspections along with interviewing and coaching sessions.

Topics: Voluntary Audits, FDA, Medical Device Single Audit Plan, Routine Inspection Plan

Posted by John Lehmann on Fri, Mar 04, 2016

A Recipe for a Successful Study Start-up

There are many factors that go into a successful clinical study start-up.  Having the proper team assembled can be a critical factor in the success of any study. Choosing the right site is another factor that can make or break a successful study start-up.  Having a research coordinator and principal investigator that are engaged is important too. 

Topics: Study Start-up, IRB, Sponsor, Site Staff

Posted by John Lehmann on Fri, Jun 03, 2016

Why Do We Need to Audit?

How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, 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. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

Topics: Auditing, Clinical Monitoring, Quality Assurance

Posted by Scott Schisler on Fri, Mar 18, 2016

Did You Know WHO Published GCP Before ICH?


You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the past couple calendar years.

Back in the early 1960’s, public perception of clinical research began to take a turn as talks and frightful images of the Thalidomide tragedy gained national news. In this case, Congress managed to pass new legislation to attempt to mitigate the issue (the Kefauver-Harris Amendment, respectively), but who couldn’t be left wondering “What’s the next terrible course of events that will happen?”

Topics: Good Clinical Practice, World Health Organization, History of Clinical Research, IMARC Research, International Conference on Harmonization

Posted by Jaime Wynbrandt on Fri, Feb 19, 2016

Post-Approval Studies: Similarities and Differences from Pivotal Studies

FDA has the authority to require Sponsors to conduct a Post-Approval Study (PAS) at the time of approval of a Pre-Market Approval (PMA) to assess the continued safety and effectiveness of an approved device. Failure to complete a Post-Approval Study could result in the FDA taking away the PMA. How are Post-Approval Studies similar and different to Pivotal Studies?

Topics: Post Approval Studies, FDA, Pre-Market Approval, IDE Studies

Posted by Jaime Wynbrandt on Tue, Feb 16, 2016

Compassionate Use vs. Planned Protocol Deviation - What is the Difference?

A group of us found ourselves asking this very question after a monitoring visit…what is the difference between a compassionate use subject and a subject who is enrolled in a study without meeting all the inclusion/exclusion criteria (planned protocol deviation)? In both cases the subject does not meet inclusion/exclusion criteria.

As always, we took it to the Federal Regulations/Guidances to see what they said.

Topics: Compassionate Use, Protocol Deviations, FDA

Posted by Kelly Jasko on Thu, Feb 11, 2016

Conducting International and U.S. Clinical Research

On a recent monitoring visit a Research Coordinator was inquiring about a Sponsor’s international research sites and if there were any specific policies on accepting clinical data from foreign/non-U.S. clinical sites.  For this particular study the Research Coordinator expressed interest on how these sites support a premarket submission study conducted in the United States.

Section 569B of the Federal Food, Drug, and Cosmetic Act states that “In determining whether to approve, license, or clear a drug or device pursuant to an application submitted under this chapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug or device in the United States.” In other words, any data obtained from outside of the United States for a clinical study will be held to the same standards as that data obtained within the U.S. 

Topics: FDA, U.S. Clinical Research, International Clinical Research

Posted by Jaime Wynbrandt on Fri, Jun 03, 2016

Planned Protocol Deviations- Should Sponsors Notify FDA?

During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A rational was provided on why the subjects were being enrolled in the study. The site submitted the planned protocol deviations to the IRB and received IRB approval prior to enrolling the subjects. The Sponsor did not seek prior approval from the FDA, but did notify them of the deviations via the Annual Progress Report (APR).

From the FDA’s perspective, did the Sponsor do enough?

Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Clinical Monitoring

Posted by Emily Haglund on Fri, Feb 05, 2016

Sharing of Clinical Trial Data – Considerations for Researchers to Show Their Work...

The sharing of clinical trial data has become an increasingly discussed topic in the scientific community and could soon create impacts beyond that of scientists that include the public and those that participate in clinical research. The concept focuses on the sharing of clinical trial data that led to conclusions presented in scientific publications. It is a way for researchers and scientists to “show their work” and support how conclusions were reached.

Topics: Institute of Medicine, International Committe of Medical Journal Editors, Clinical Trial Data

Posted by Jaime Wynbrandt on Mon, Feb 01, 2016

Study Closure and Final Sponsor Report

We have all had sites that close prior to the study actually being completed. It is always asked if the site’s IRB allows them to close the study and submit the Sponsor’s final report when the study is completed or if the study needs to remain open at the site to allow the final report to be received by the IRB.

If the study needs to remain open with the IRB, this can become time consuming and costly if the study completion is several years away.  The site would need to submit for Continuing Review each year until the Sponsor’s final report is received.

Topics: FDA, IRB, Sponsor Report, Study Closure

Posted by John Lehmann on Fri, Jan 29, 2016

FDA Hits User-Fee ERA Record

The number of original PMAs for completely high-risk devices and panel track supplements for major new updates approved by the FDA, was at its highest level since 2001.  Approvals increased to 56% in 2015 compared to the previous year and almost double the 2013 total.

So is this the new normal or just a one-year spike? 

Topics: FDA, CDRH, William Maisel, User Fee, Paul LaViolette

Posted by Mary Lewis on Wed, Jan 27, 2016

21 CR 812.100: A Medical Auditor's Favorite Regulation

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

21 CFR 812.100 falls under Subpart E- Responsibilities of Investigators of the IDE Regulations.  This regulation succinctly details investigator responsibilities in just two sentences.

Topics: Investigator Responsibilities, Clinical Reearch, FDA, 21 CR 812.100

Posted by John Lehmann on Fri, Jan 22, 2016

A Question of Disclosure: FDA Findings and Publications

When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”

Topics: Charles Selfe, FDA Warning Letters, FDA Inspection

Posted by Michael Marotta on Fri, Jan 15, 2016

What to do When New information is Presented?

On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the public on “emerging signals” regarding medical devices that are already used in clinical practice.  The FDA defined an emerging signal as “new information about a medical device” that:

  1. The Agency is monitoring or analyzing
  2. Has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
  3. Has not been fully validated or confirmed
  4. For which the Agency does not yet have specific recommendations

Topics: Draft Guidance, FDA, Emerging Signals

Posted by Michael Marotta on Wed, Jan 13, 2016

Hear Ye, Hear Ye, This Meeting is Called to Order

This is the second of a two blog series on the Draft Guidance for Institutions and IRBs.  The first blog was published on January 7, 2016.

In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.

Topics: Draft Guidance, IRBs, FDA, Institutions

Posted by Emily Haglund on Thu, Jan 07, 2016

Minutes of Institutional Review Board (IRB) Meetings: Draft Guidance for Institutions and IRBs

The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.

Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings

Posted by John Lehmann on Fri, Apr 08, 2016

Significant Risk vs. Non-Significant Risk Determination

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.”  Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).

Topics: Dr. Harvey Arbit, Signficant Risk, Non-Signficant Risk, FDA

Posted by John Lehmann on Tue, Dec 29, 2015

The History of Clinical Research eBook

For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

Topics: Sandra Maddock, History of Clinical Research, IMARC Research

Posted by Toni Hegyi on Fri, Dec 18, 2015

Enrolling Employees or Clinic Staff: Is it Acceptable?

Little discussion can be found around the question of whether or not employees of an institution should be permitted to participate as subjects in human research conducted by the institution they work for. To date, there is no specific guidance (protection/provisions) provided by the federal regulations governing research with human subjects. The Office for Human Research Protections (OHRP) presents consideration around students, employees, and normal volunteers in Chapter VI, “Special Classes of Subjects,” of its IRB Guidebook. Similarly, the Centers for Disease Control and Prevention (CDC) offers guidance for employee participation in research. While the enrollment of employees is allowed, there is a potential for fundamental ethical provisions to be compromised. Both the study sponsor and the Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) have a responsibility to address the management of these issues:

Topics: Clinical Research, IRB, Enrolling Employees,, Clinical Staff,

Posted by Lauren Luzar on Tue, Dec 15, 2015

Should the FDA Regulate Laboratory Developed Tests?

FDA defines the term laboratory developed test (LDT) as an in vitro diagnostic test (IVD) that is intended for clinical use and designed, manufactured and used within a single laboratory.  In 1976, the Medical Device Amendments (MDA) was enacted and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a system for the regulation of medical devices intended for human use.  Although considered IVDs, the FDA chose to exercise enforcement discretion for LDTs with the justification that these tests were relatively simple, used only in the lab that developed the tests and were used for rare conditions. 

Topics: Laboratory Developed Tests, FDA, LDT

Posted by John Lehmann on Thu, Dec 10, 2015

Combination Product Pathway

During his November 17th conformation hearing at the Senate Health, Education, Labor and Pensions Committee FDA commissioner nominee Robert Califf indicated that the FDA could have a new combination pathway ready for approval within a year.  He is trying to replace Margaret Hamburg, who left the FDA back in April.

During the hearing Califf agreed that the FDA’s existing structure for reviewing combination products is not suitable.  “It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public the proposed treatment is safe and effective.

Topics: Combination Products, FDA, Robert Califf, Product Pathway

Posted by John Lehmann on Tue, Dec 08, 2015

Using Risk Management in Clinical Research

Please take time to view Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline.  The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

Topics: ISO 14155, Risk Management, GxP Lifeline

Posted by Mary Lewis on Tue, Dec 01, 2015

FDA Audit Prep

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit.  It is helpful for a site to know what the FDA auditor will use during their review.  In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations. 

Topics: Audit Prep, BIMO Checklist, FDA

Posted by Brandy Chittester on Fri, Jun 03, 2016

10 Attributes of a Great Monitor

Monitoring clinical trials at a high level requires a unique set of traits, skills, and abilities. While monitors often have diverse backgrounds and experiences, there are specific attributes that characterize great monitors and separate them from the rest of the pack. The following list identifies those attributes and explains why each is instrumental to clinical monitoring. This list is not ranked in any particular order and is not meant to be all inclusive; please share your thoughts!

Topics: Medical Devices, Clinical Research, Clinical Monitoring, 10 Attributes

Posted by John Lehmann on Thu, Nov 19, 2015

IMARC Expand Service Offerings

IMARC Research has launched independent oversight capabilities by adding Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs) to its existing monitoring, auditing, training, project management and consulting services.

Topics: Sandra Maddock, IMARC Research

Posted by Shawn Kennedy on Thu, Nov 12, 2015

What is the FDA Form 3674?

Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrently conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?”  I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam.  However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was.  At our auditor’s good suggestion, we took to finding the answer.  That night, she emailed FDAs FDAs gcp.questions@fda.hhs.gov for their input.  This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.

Topics: 510(k) Program, Clinical Auditing, FDA, Form 3674

Posted by Ryan Begun on Thu, Nov 05, 2015

Expedited Review: Breakthrough Therapy

In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the Sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.

Topics: FDA, Expedited Review

Posted by John Lehmann on Mon, Nov 02, 2015

ALCOA - The Best Way to Document Your Work

 When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”.  As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

Topics: 21 CFR 58.130 (15), ALCOA Checklist, FDA

Posted by Brad Liebermann on Tue, Oct 27, 2015

Financial Disclosure of Equity Interest

The FDA evaluates the disclosure of financial information from clinical investigators to determine the reliability of data submitted to the FDA and identify steps to minimize the potential for bias. The value of an investigator’s financial interest in the sponsor may have the potential to increase if the product is approved. 21 CFR 54 states that investigators must disclose significant equity interest in the sponsor, any proprietary interest in the sponsor and significant payments of other sorts from the sponsor during the time the investigator is carrying out the study and for a period of one year following completion of the study.

Topics: Draft Guidance, Financial Disclosure, FDA

Posted by Shawn Kennedy on Thu, Oct 22, 2015

New FDA Draft Guidance: Revised ICH Guidelines for Good Clinical Practice

Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.  The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland).  This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996. 

Topics: Good Clinical Practice, ICH GCP, Draft Guidance, FDA

Posted by Leonard Basobas on Thu, Nov 05, 2015

The Post Market Surveillance Study


 A police siren blares, but only for a brief moment indicating that the police officer just wanted to make his presence known.

In turn, your surprise quickly morphs into frustration as you see the flash of red and blue lights in your rear view mirror.  You pull to the side of the road.

“Do you know why I pulled you over?” the officer posits staring at a roll of papers in his hand.

“Honestly, I am at a loss sir?” you sarcastically reply.  “I just got on the highway to test out my new car, which is just off the assembly line, I might add, and I wasn’t even up to the speed limit yet.”

Topics: FDA, Post Market Surveillance Study, Section 522

Posted by Kelly Jasko on Tue, Nov 24, 2015

FDA Establishing a Patient Engagement Advisory Committee (PEAC)

As we are in an era of “patient-centered” medical care, the focus of health care now enables patients to make choices regarding their physicians, hospitals, and treatment options.  The transparency of medical costs allow patients to “shop-around” for their healthcare preferences, and gone are the days of simply letting health care providers guide medical decisions.  In a recent article on the FDA’s website, they have fostered this idea and announced their first ever Patient Engagement Advisory Committee (PEAC). This committee is part of the FDA’s Patient Preference Initiative, which was launched in 2013, and marks an additional way to incorporate patients’ views on benefits and risks with those of the FDA’s scientists, engineers, and medical professionals.  

Topics: FDA, Patient Engagement, PEAC

Posted by John Lehmann on Tue, Oct 06, 2015

Research Coordinator Support: Preventing Costly Data Delays

The extreme workload of research coordinators is well documented in the clinical research industry. Clinical Research Coordinators (CRCs) are often tasked with clinical care and administrative duties – like budget negotiation and data entry into electronic databases.   This intense workload frequently impacts the timeliness of data entry and safety reporting.

Topics: IMARC Whitepaper, Research Coordinator Support

Posted by John Lehmann on Fri, Oct 02, 2015

The Sponsor-Investigator: Wearing Two Hats

You may have heard the term Sponsor-Investigator before, but just who are they and what do they do?  Just as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation.  This may sound simple, but in actuality, the role can be quite complicated.  However, like anything else, with proper preparation and support it can be accomplished.  Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields.  They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.

Topics: Sponsor-Investigator, FDA

Posted by Lauren Luzar on Tue, Sep 29, 2015

Leveraging Adult Clinical Data for Pediatric Medical Devices

On May 6th, 2015 the FDA released a draft guidance on Leveraging Existing Clinical Data for Extrapolation of Pediatric Uses of Medical Devices.  This guidance expands on the information provided in the final Premarket Assessment of Pediatric Medical Devices guidance originally published in 2004 and updated in 2014. The FDA believes that leveraging relevant clinical data may lead to more devices being approved for pediatrics.  The guidance defines pediatric patients as 21 years or younger at the time of diagnosis or treatment.

Topics: Medical Devices, Clinical Data, FDA

Posted by Shawn Kennedy on Thu, Sep 24, 2015

The Common Rule (1991)

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.

Topics: History of Clinical Research Timeline, IMARC Research, The Common Rule

Posted by Jaime Wynbrandt on Tue, Sep 22, 2015

Does the PI Have to Sign the Clinical Investigational Plan?

Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.

Topics: Principal Investigator, Clinical Investigational Plan, FDA, 1572 Form, ICH GCP E6 8.2.2

Posted by Ashton Steinhagen on Fri, Jun 03, 2016

Do The Benefits Outweigh The Risk?

I was reading an article on the FDA’s website over concerns related to devices causing serious adverse events, the determination that the benefits outweigh the risks was the conclusion.  This raises some interesting questions with regards to patient safety.  The article specifically talks about devices that are used primarily as a bridge to transplant (BTT) or destination therapy in relation to severe heart failure.  Having been trained on the particular devices in question and taking care of the patient population whom received the devices, these patients have very few if any options.  Determining whether or not a device is safe is one thing but distinguishing if a device that has been shown to cause serious adverse events is acceptable in a certain patient population is another.

Topics: Medical Devices, FDA, Risk, Title 21 Part 812.30

Posted by Mary Lewis on Mon, Apr 11, 2016

Can Improving Quality in Device Trials Shorten Time to Market?             

  A medical device company files a marketing application with FDA and awaits a determination on whether or not its clinical trial data is sufficient to support product approval and/or clearance.

Topics: Quality Improvement, Medical Device Trials, FDA

Posted by Shawn Kennedy on Thu, Sep 03, 2015

International Conference on Harmonisation (ICH): 1990

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.

Beginning in the 1980’s, Europe began the push for harmonizing regulatory requirements, primarily to create a single market for pharmaceuticals at the time.  More specific plans were developed at the World Health Organization Conference of Drug Regulatory Authorities in 1989.

Posted by John Lehmann on Tue, Sep 01, 2015

Conducting a Well-Controlled Clinical Study When Clinical Data is Required

There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program. In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

Topics: 510(k) Program, IMARC Whitepaper, FDA

Posted by John Lehmann on Tue, Aug 25, 2015

Trust the Process – A Case Study

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something.  Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

Topics: FDA Audit, FDA Inspection, BIMO

Posted by John Lehmann on Wed, Aug 19, 2015

Back Translations

On a recent monitoring visit, the coordinator asked an IMARC monitor if the study sponsor could have their consent translated into Spanish. However, the site had one caveat – their IRB also required a “back translation” of the translated consent. Why would the IRB require this back translation?

Topics: Consent, Back Translation, Section 50.20

Posted by John Lehmann on Thu, Aug 13, 2015

Why Do We Need to Audit?

How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, 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. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

Topics: GCP, Auditing, Quality Assurance

Posted by John Lehmann on Mon, Aug 10, 2015

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within a clinical trial. To achieve this, the sponsor must invest resources into these different aspects of a clinical trial. One specific aspect of integrating quality involves how risks are approached and managed throughout the course of a study. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released documents in 2013 focused on the integration of traditionally development and manufacturing quality principles, including risk-based approaches into the clinical research industry. FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials” both describe how regulators now expect a quality, risk-based approach when conducting clinical research. These documents are examples of the shift toward quality techniques underway within industry when developing, initiating, and executing studies.

Topics: Risk Management, IMARC Whitepaper, FDA

Posted by John Lehmann on Wed, Aug 05, 2015

FDA Prioritizes Combo Product Reforms

Both companies and the FDA continue to be frustrated with the mismatches between drug and deviceFDA_Prioritizes_Combo_Product_Reforms-1 regulations along with the communication challenges between the product centers that lead to inefficiencies.  FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.

Topics: Jeffrey Shuren, Combination Products, FDA, Robert Califf

Posted by John Lehmann on Fri, Jun 03, 2016

5 Steps to Make Your Monitoring Efforts Matter

Monitoring remains our main focus at IMARC Research.  As discussed in a previous whitepaper, “Monitoring as a Mindset”, monitoring is defined by the FDA as the act of overseeing an investigation.  Specifically noted in 21 CFR 812.43, sponsors are required to select monitors qualified by training and experience.  In addition, 812.46 states that monitoring investigations should include securing compliance at investigative sites, whenever necessary.

Topics: 21 CFR, IMARC Whitepaper, FDA, Clinical Monitoring

Posted by Shawn Kennedy on Wed, Jul 22, 2015

FDA Regulations - Title 21: 1981

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.

In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations.  The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research.  However, not too long ago, the regulations we freely refer to now did not exist.  It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 - Food and Drugs

Topics: History of Clinical Research Timeline, FDA Regulations, Code of Federal Regulations (CFR) Title 21

Posted by John Lehmann on Mon, Jul 20, 2015

Ensuring Proper Training for Clinical Research Staff

Please take time to view Sandra Maddock’s  article “ Ensuring Proper Training for Clinical Research Staff in Less Time” that was recently posted on GxP Lifeline.  With the clinical research industry experiencing continued growth,It only makes sense then that clinical research professionals need continuing education to keep up with a rapidly evolving industry.

Topics: Sandra Maddock, Training, GxP Lifeline, Clinical Research

Posted by John Lehmann on Wed, Jul 15, 2015

Inclusion and Exclusion - Behind the Scenes

Investigational plans, or protocols, are developed with what authors believe are clear inclusion and exclusion criteria that must be confirmed prior to the initiation of any investigational treatment or test.  There are certain inclusion criteria that are common including an age range, willingness to provide consent and adhere to the study schedule, and particular condition or diagnosis. Common exclusion criteria include a past medical diagnosis, excluded treatments or medications, or family history of a certain disease. According to 21 CRF 812.110 (b), it is the investigator’s responsibility to conduct the trial according to the investigational plan and therefore, adequately review medical history, interview the subject, and obtain labs or imaging to confirm that all inclusion and no exclusion criteria are met..

Topics: Inclusion Criteria, Exclusion Criteria, 21 CRF 812.110 (b)

Posted by Ashton Steinhagen on Tue, Aug 11, 2015

Site Selection - What to Look For?

Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task  for a sponsor.  Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen.  Choosing the wrong sites could have a detrimental effect on the study including:

Topics: Sponsors, Site Selection, FDA

Posted by John Lehmann on Tue, Jul 07, 2015

2014 FDA Top Ten Warning Letter Findings

For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review. 

Topics: BIMO Metrics, Top 10, FDA, Warning Letters

Posted by Danielle Sas on Fri, Jun 26, 2015

Do You Know the Difference Between a Consent for Research and a Standard Consent for Treatment?

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

Topics: Informed Consent, FDA, Clinical Research, Standard Consent

Posted by Mary Lewis on Tue, Jun 23, 2015

Direct Access to Electronic Medical Records for Data Verification

I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system.  She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification. 

We all know that source documents are the gold standard for data verification.  Monitors and auditors ideally should be granted direct access to this information in order to verify study data; however with the plethora of concern surrounding private health information and individual privacy it seems to be getting more difficult to access this information easily.

Topics: Electronic Source Documentation, EMR, SDV, Direct Access

Posted by Natalie Jarmusik on Fri, Jun 19, 2015

Medical Device Regulations

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

Topics: History of Clinical Research Timeline, FDA, Medical Device Industry, President Gerold Ford

Posted by Stephani Hulec on Wed, Jun 17, 2015

Essential Document Review, What are you Looking For?

As monitors we spend a significant amount of time reviewing the essential documents at the site during a monitoring visit.  The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.

Topics: Monitor, Regulatory Binder, Essential Documents, Sites

Posted by John Lehmann on Fri, Jun 12, 2015

New House Bill Could Reduce 510(k) Submissions

On May 21st the House Energy and Commerce committee unanimously passed a bill that would allow medical device companies to bypass 510(k) submissions for certain product modifications.  The 21st Century Cures bill will now move to the House floor, and bill sponsors hope for a vote by the end of the year.

The device “third-party quality system assessment section” was revised by the committee and would let companies make a device modification that would typically require a 30-day notice of a “special” PMS supplement could without a submission by having their quality system specially certified by a third-party auditor.

Topics: FDA, 510(k), House of Representatives, 21st Century Cures Bill

Posted by Paul Cobb on Tue, Aug 11, 2015

Can Informed Consent be Obtained Electronically?

In March, 2015, FDA released a new draft guidance: Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.

FDA defines electronic informed consent (eIC) as using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.

Topics: Informed Consent, FDA, Electronic

Posted by John Lehmann on Fri, Jun 05, 2015

Risk Management Whitepaper

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: FDA Guidance, Risk Management, IMARC Research Whitepaper

Posted by Ryan Begun on Thu, Jun 04, 2015

Expedited Review: Fast Track

In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.

The Fast Track approach to FDA expedited review is intended for drugs aimed to treat serious or life-threatening conditions and fill an unmet medical need. According to Section 506(b) of the FD&C Act, a product is eligible to be labeled as a fast track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”

Topics: FD&C Act, FDA, Fast Track

Posted by Sandra Maddock on Thu, May 28, 2015

Do Form FDA 483s Matter Anymore?

For clinical researchers, our “grade card” comes when the FDA inspects us.  We all want to be told that we’ve operated in a compliant manner and that there were no findings.  The alternative is to receive a Form FDA 483 (483) for significant deviations at the close of the inspection.  When I got my first 483 as a research coordinator 18 years ago, I remember thinking to myself “I’m not going to let that happen again.”  In my opinion, it was an indication that we had not delivered A+ work.  Since the stakes are so high in this environment, and we’re asking patients to trust us to perform, it was a big wake up call for me. 

Topics: IMARC Research, FDA, Form 483s

Posted by John Lehmann on Fri, Jun 03, 2016

Your Blog Will Voluntary Audits Help the FDA?

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

Topics: Medical Devices, FDA, Auditing

Posted by Shawn Kennedy on Tue, May 19, 2015

The National Research Act - 1974

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

On July 12, 1974, President Richard Nixon signed the National Research Act into law.  In doing so, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created.  The main purpose of the act was for the newly established commission to identify basic ethical principles to be followed when conducting biomedical and behavioral human subject’s research.  Additionally, the commission was tasked with developing guidelines that would help the medical community conduct research in accordance with the principles they set forth.  Some concepts the commission were to consider included: 

Topics: Tuskegee Syphilis Study, History of Clinical Research Timeline, The National Research Act

Posted by John Lehmann on Fri, Jun 03, 2016

Draft Guidance for Advisory Panels Released

On April 1st, the FDA issued a draft guidance that provides more comprehensive information for industry and CDRH on the processes associated with panel device meetings.  The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels overseen by FDA's Center for Devices and Radiological Health (CDRH), the FDA center in charge of regulating medical devices.

Once finalized, the updated guidelines will replace a 2000 CDRH guidance document on the panel process and a 1991 blue book memo.  Thus, the guideline clarifies the circumstances in which the CDRH consults with a device advisory panel, the conduct of panel meetings and the expected timelines to prepare for a panel meeting.

Topics: Medical Devices, Draft Guidance, FDA, CDRH

Posted by John Lehmann on Tue, May 12, 2015

The Best Way to Document Your Work

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

Topics: Good Clinical Practice, Federal Regulations, ALCOA Checklist

Posted by John Lehmann on Fri, Jun 03, 2016

Clinical Research Training Requirements

IMARC Research’s new whitepaper examines the similarities and differences between the current US regulations and places them within the context of any number of roles found within the realm of clinical research. While there are no direct references within the regulations as to what types and to what degree training is required, a well-developed training curriculum is a prerequisite for quality research.

Topics: Medical Devices, GCP/Regulatory Training, IMARC Research Whitepaper

Posted by John Lehmann on Tue, May 05, 2015

Screening or Consent: Which Came First?

 

The informed consent process is arguably one of the most important parts of a clinical research study. Fromthe Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

Topics: Informed Consent, Research Coordinators, GCP

Posted by John Lehmann on Tue, Apr 28, 2015

Clinical Research Training Fundamentals

Proper training assures sponsors organizations that their research meets all the industry standards of compliance, and that their clinical studies will be conducted in a well-controlled, high quality manner that will withstand the rigors of regulatory inspection.

Topics: IMARC University, Online Training, Training Fundamentals Checklist

Posted by John Lehmann on Thu, Apr 23, 2015

FDA Still Honing Medical Device Regulatory Process

Former FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.

Topics: Margaret Hamburg, FDA, Medical Device Regulatory Process

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Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

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.