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X making sense of safety oversight in clinical research
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Compliance In Focus

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Posted by Ashton Steinhagen on Tue, Apr 17, 2018

Enhancing Transparency of 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.

Topics: FDA, Clinical Data Summary Pilot Program, Transparency

Posted by Lisa Wickert on Tue, Apr 10, 2018

The General Data Protection Regulation: Impact on Personal Data Use in Clinical Trials

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.

Topics: European Union, EU, General Data Protection Regulation

Posted by John Lehmann on Wed, Apr 04, 2018

Do You Conduct Clinical Vendor Audits?

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.

Posted by John Lehmann on Tue, Mar 27, 2018

What Makes A Well Controlled Clinical Trial?

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:

Topics: Well-Controlled Clinical Study, clinicaltrials.gov

Posted by John Lehmann on Thu, Mar 15, 2018

Making Sense of Safety Oversight in Clinical Research Webinar

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.

Topics: IMARC Research, Safety Oversight, Webinar

Posted by John Lehmann on Wed, Mar 14, 2018

What Is New In GCP

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.

Topics: GCP, IMARC Research Whitepaper

Posted by John Lehmann on Thu, Mar 08, 2018

Choosing the Right Clinical Project Manager

The right clinical research project manager will keep your trial on track so you can bring your device to market faster. The wrong one can bring unwelcome interference, hindering progress.

Posted by John Lehmann on Tue, Feb 27, 2018

Why Outsource Administration of Your Safety Oversight Group?

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.

Topics: Outsourcing, Safety Monitoring Oversight

Posted by Rachel Silver-Kessler on Tue, Feb 20, 2018

Four Steps to Safety Oversight: DSMBs, CECs, and Medical Monitors

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:

  1. Follow Thoughtful Procedures
  2. Gain Consensus and Implement a Charter
  3. Maintain Well-Organized Documentation
  4. Build Quality Control Steps Into Processes

Topics: CEC, DSMB, Safety Oversight, Medical Monitors

Posted by Rachel Silver-Kessler on Tue, Feb 13, 2018

Safety Oversight Options

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.

Topics: FDA, Safety Monitoring Oversight

Posted by Ashton Steinhagen on Tue, Feb 06, 2018

Compassionate Use without an IDE

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.

Topics: Compassionate Use, IDE Studies

Posted by John Lehmann on Fri, Feb 02, 2018

FDA’s 2018 Strategy Includes Digital Health and Diagnostic Focus

US FDA Commissioner Scott Gottlieb provided some key digital health initiatives along withFDA 2018 Strategy.jpg his vision on how he wants the agency to work with the sector in the coming years.

Topics: FDA, Digital Health,, Diagnostic

Posted by John Lehmann on Tue, Jan 30, 2018

Clinical Support Service Pain Points


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.

Topics: Clinical Reseasrch, Clinical Support Services

Posted by John Lehmann on Wed, Jan 24, 2018

IMARC Research Opens New Office in Minneapolis Area

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

Posted by John Lehmann on Wed, Jan 17, 2018

Writing a Great Monitoring Report – From Beginning to End

Writing great monitoring reports is not just about writing the report. It requires an in depth How to Write a Great Monitoring Report Checklist.pngknowledge 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.

Topics: Monitoring Report, Writing

Posted by John Lehmann on Wed, Jan 17, 2018

Creating a Blueprint for Training 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: IMARC University, Clinical Training

Posted by John Lehmann on Thu, Jan 04, 2018

Tips for Surviving an FDA Inspection

You just got the phone call; the Food and Drug Administration (FDA) Inspector is coming for a visit.

Topics: FDA Inspection, BIMO Inspection

Posted by Victoria Sawczak on Tue, Dec 12, 2017

FDA Suggested Controls on Interoperable Devices

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).

Topics: FDA Guidance, Interoperable Devices

Posted by Emily Zetzer on Fri, Dec 08, 2017

The Milgram Experiment

 

Topics: History of Clinical Research Timeline, The Milgram Experiment

Posted by Cristina Calvin on Tue, Dec 05, 2017

FDA Releases Breakthrough Devices Program Draft Guidance

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.

Topics: Medical Devices, Draft Guidance, FDA

Posted by John Lehmann on Tue, Nov 21, 2017

Giving your Studies the FAIR Shake

IMARC’s FAIR Shake technique takes a complicated maze of regulations and breaks them down into four simple areas your team can apply to clinical research questions.

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.

Topics: FDA Regulations, FAIR Shake technique, IMARC Research

Posted by John Lehmann on Thu, Nov 16, 2017

Conducting Clinical Research Utilizing a Quality Systems Approach

FDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks.

Topics: Medical Device Studies, Clinical Research, Quality Systems

Posted by Toni Hegyi on Tue, Nov 07, 2017

PIP Breast Implant Scandal: A Story That Triggered Change

In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher turned medical sales representative, and Henri Arion worked together in this field; following the death of Arion in a plane crash, Mas went on to launch Poly Implant Prothese (PIP) in 1991. It was the beginning of a company that would produce approximately two million sets of silicone breast implants over the course of a 20 year period and in its path, create a global health scare and shape medical device regulations. The silicone-based scandal came about when PIP implants made from a cheaper, industrial-grade silicone (that was not approved for medical use) were rupturing at a rate that was double the industry average. When compromised, the silicone gel was known to cause inflammation and possible scarring, and these implants continue to raise questions over the possibility of other harmful long-term affects. The timeline below summarizes the key points of the complex story:

Topics: History of Clinical Research Timeline, PIP Scandal

Posted by Sandra Maddock on Wed, Nov 01, 2017

Final Rule for Clinical Trials Registration and Results Submission

Clinicaltrials.gov is a database of clinical research trials being conducted both in the United States and internationally and is intended to be a resource for patients and researchers alike. Housed by the United States National Library of Medicine, clinicaltrials.gov currently has postings for over 257,000 clinical studies that are being conducted in over 200 countries. On January 18, 2018, the “Final Rule for Clinical Trials Registration and Results Submission” will go into effect. This rule provides further clarification on the “What, How, and When” of clinical trial reporting requirements.

Topics: Clinical Studies, FDA, clinicaltrials.gov

Posted by Lisa Wickert on Fri, Oct 27, 2017

FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

On August 31, 2017 The Food and Drug Administration (FDA) issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.” This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.

Topics: Medical Devices, New FDA Guidance, Real-World Evidence

Posted by John Lehmann on Wed, Oct 25, 2017

Drug and Medical Device Clinical Trials 101

Most medical professionals enjoy being on the forefront of new clinical treatments, techniques and products. Drug and device research trials are a great opportunity for those in the healthcare field to learn about and assist in the development of revolutionary ways to treat patients, before they’re introduced to the public. These studies can provide invaluable information and learning experiences to everyone involved. IMARC has published a whitepaper on this important topic.

Topics: medical device clinical trials

Posted by Carla Glass on Mon, Oct 16, 2017

Questions Surrounding Electronic Informed Consents

What is electronic informed consent?

Topics: Informed Consent, FDA, Electronic

Posted by Brandy Chittester on Thu, Oct 05, 2017

How to Write a Great Monitoring Report

Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.

Topics: IMARC Research Whitepaper, Monitoring Report

Posted by Danielle L. Kerr on Tue, Oct 03, 2017

WIRB Policy Update August 17, 2017

If you have run a clinical trial, you are most likely familiar with the Western Institutional Review Board, more commonly referred to as WIRB. They are the largest central IRB in the world, servicing pharmaceutical, device, and biologics trials across the globe. One of their most useful resources for clinical professionals is “A Guide for Researchers”, which outlines their current policies. These policies are based on an integrated regulatory framework, consisting of the Food and Drug Administration (FDA) regulations (namely 21 CFR 50 & 56), the Department of Health and Human Services (HHS) (45 CFR 46 Parts A-D), and the International Conference of Harmonization (ICH) Guidance for Industry (E6- Good Clinical Practice). As the clinical research landscape continues to evolve, the WIRB policies are adjusted to match that climate. This is evident in the four revisions/updates to “A Guide for Researchers”, updated August 17, 2017. These updates are described below.

Topics: FDA, WIRB Policy

Posted by Michael Marotta on Thu, Sep 28, 2017

IVD 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: FDA, In Vitro Diagnostics

Posted by John Lehmann on Thu, Sep 21, 2017

Safety Monitoring Oversight Adds Value to Your Study

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: CEC, DSMB, Safety Monitoring Oversight

Posted by John Lehmann on Tue, Sep 19, 2017

Working with IMARC: Your Partners in Compliance

Our latest guide is an in-depth look at how IMARC can work with you to ensure compliance throughout the Clinical Trial Lifecycle, including case studies within the following areas of service: Monitoring, Auditing, Project Management, Safety Management, Training and Consulting.

Topics: Medical Device CRO, Compliance Partners

Posted by John Lehmann on Thu, Sep 14, 2017

Ensuring Compliance at Every Stage In the Clinical Trial Lifecycle

Topics: Medical Device Trials, Compliance Partners, Clinical Trial Lifecycle

Posted by John Lehmann on Wed, Aug 30, 2017

Giving Your Studies a FAIR Shake

I was talking with a professional colleague recently, who referenced IMARC Research’s FAIR Shake™ method as a tool she uses regularly in her clinical research activities. It prompted me to feature our whitepaper on the FAIR Shake™ training program. Even though it is one of our older papers, it is still a useful tool for clinical research professionals. This technique helps you bridge the gap between knowledge and application.

Topics: FAIR Shake technique, Clinical Research

Posted by Elizabeth Braschayko on Thu, Sep 14, 2017

Top 5 Reasons an IRB Receives An FDA Warning Letter

Institutional Review Boards (IRBs) review clinical investigations that the FDA regulates, but the system of checks and balances goes both ways. The FDA has established regulations regarding IRB oversight, which are intended to protect the rights and welfare of human subjects. The FDA conducts inspections to ensure IRBs comply with these regulations and may issue warning letters for a variety of reasons.

Topics: FDA Warning Letters

Posted by John Lehmann on Tue, Aug 15, 2017

Our Site Got a 483 - Now What?

Your friends from the FDA stopped by and noted several red flags at your site in a Form 483. Now what? The most important thing you can do as a principal investigator is accept responsibility for these violations and demonstrate you're taking steps to address them.

Topics: Form 483, Principal Investigator, FDA

Posted by Emily Zetzer on Tue, Aug 08, 2017

Pennsylvania Act 135

Informed consent is a process designed to protect the rights and welfare of a patient while providing a description of risks, alternatives, and any/all pertinent information that may alter a patient’s willingness to participate.

Topics: Informed Consent, Pennsylvania Act 135

Posted by Elizabeth Braschayko on Wed, Jan 03, 2018

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.

Topics: FDA Warning Letters, 2016, Clinical Investigators

Posted by John Lehmann on Wed, Jul 26, 2017

Comparing Drug and Device Trials

IMARC Research has published a whitepaper outlining the similarities and differences between drug and device clinical trials. Since IMARC focuses primarily in the medical device space, 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 an infographic as a quick reference.

Topics: Drugs vs. Devices, Clinical Trials

Posted by Mary Lewis on Tue, Jul 18, 2017

Take a Quality Snapshot of Your Clinical Study

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, Quality Assurance

Posted by Lisa Wickert on Tue, Jul 11, 2017

Updated Bioresearch Monitoring Program (BIMO) Guidance Manual

The Food and Drug Administration (FDA) released an updated Guidance for FDA Staff for Sponsors, Contract Research Organizations (CROs) and Monitors on April 19, 2017 as part of the Bioresearch Monitoring (BIMO) program. The updated version contains revisions to Part III, section D, which provides additional instructions to FDA investigators related to www.ClinicalTrials.gov reporting and registration requirements that came into effect on January 18, 2017 in 42 CFR Part 11.

Topics: BIMO Metrics, FDA, BIMO Guidance Manual

Posted by John Lehmann on Mon, Nov 06, 2017

FDA User Fee Financial Impact

I ran across an article in a recent edition of Medtech Insight that focused on the 10 key details from US FDA agreements that will impact medical device and diagnostics companies. The article indicates that the US FDA user-fee reauthorization legislation is proceeding through Congress, most recently with a May 11 markup in the Senate Health, Education, Labor and Pensions Committee. Lawmakers would like to see a bill passed in July.

Topics: Congress, FDA, user-fee reauthorization

Posted by John Lehmann on Tue, Jun 27, 2017

When to Enlist a DSMB or CEC For Your Clinical Trial [INFOGRAPHIC]

Evaluating patient data to ensure the continued safety of clinical trial subjects is an important part of a sponsor’s responsibility. Sponsors often enlist the help of independent boards to ensure expert oversight and eliminate the potential for bias.

Topics: CEC, DSMB, Safety Monitoring

Posted by John Lehmann on Thu, Jun 22, 2017

Device Monitoring is More Than SDV

Many believe good monitoring should heavily focus on Source Data Verification (SDV), which stripped down to its simplest meaning equates to “X=X” and “Y=Y”. And maybe some of you reading this are thinking “Isn’t that exactly what monitoring is?” While data integrity is absolutely essential, it is only the beginning of what comprehensive monitoring encompasses.

Topics: Medical Devices, Source Data Verification, Clinical Monitoring

Posted by John Lehmann on Thu, Jun 15, 2017

10 Attributes of an A+ Clinical Monitoring Service

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

Topics: CRO, Clinical Monitoring, 10 Attributes

Posted by Toni Hegyi on Tue, Jun 13, 2017

Can (Should?) a Data Safety Monitoring Board and Clinical Events Committee be Combined?

Traditionally, Data Safety Monitoring Boards (DSMBs/DMCs) and Clinical Events Committees (CECs) have been set up to operate independently from each other. They have distinct functions and as such, membership generally does not overlap. However, since the FDA has no explicit regulatory requirement for the establishment of a DSMB/CEC (except in the case of emergency research conducted under 21 CFR 50.24 (a)(7)(iv)), it raises the question as to whether or not it may be feasible or even advantageous to combine their efforts into one safety monitoring board. To explore this option, consider the following Q&A’s:

Topics: CEC, DSMB, Safety Monitoring Board

Posted by John Lehmann on Tue, Jun 06, 2017

Minimizing Risk in Imaging Clinical Trials Webinar

Sandra Maddock, CEO & President for IMARC Research will be joining Tim Kulbago, Vice President, Imaging for ERT for a webinar entitled “Minimizing Risk in Imaging Clinical Trials” webinar on Thursday, June 15th at 10:00 a.m. EDT.

Topics: Sandra Maddock, Imaging in Clinical Trials, Tim Kulbago

Posted by John Lehmann on Thu, Jun 01, 2017

Medical Device Classification Guide

A clinical trial is required for all new drugs, but this is not the case for all medical devices. Medical devices start by undergoing a risk assessment in order to determine the severity of potential harm to the user and the probability of that harm occurring. Each device is assigned to one of three classes based on this assessment, and this classification dictates whether or not a clinical trial is necessary.

Topics: Medical Device Classifications

Posted by Ashton Steinhagen on Tue, May 23, 2017

Medical Abbreviations: A Language WNL

Patient A+0x3, ST with PVCs and PACs. Lungs clear bilaterally with POX 98% on RA and SOB on exertion, PPP, NPO after midnight. PERRLA. Normal BSx4 quadrants. Abd dressing C/D/I C scant amt of serosang drainage. MAE, SBA, and OOB as tolerated. BP WNL. NS infusing @75 ml/hr through RTL PICC, F/P.

Topics: Medical Abbreviations, Research Terminology

Posted by Melissa Wollerman on Wed, May 17, 2017

Clinical Trials Day 2017: Celebrating Research Participants and Professionals Worldwide!

Clinical Trials Day is celebrated around the world on or near May 20th each year in order to commemorate the day that a Scottish naval surgeon, James Lind, conducted what is often considered the first randomized clinical trial aboard a ship on May 20th, 1747. This year, Clinical Trials Day will be celebrated on Friday, May 19, 2017. In 1747, surgeon mate James Lind administered six different methods to attempt to heal sailors that were diagnosed with scurvy, with one of the methods involving oranges and lemons. This method healed the sailors, becoming a breakthrough for an intervention of scurvy, but more importantly demonstrating the potential power of a clinical trial.

Topics: Clinical Trials Awareness Week 2017, Clinical Trials Day 2017

Posted by John Lehmann on Thu, May 11, 2017

Importance of Clinical Vendor Audits

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.

Topics: Clinical Research, Vendor Audits

Posted by Melanie Miller on Tue, May 02, 2017

Clinical Trials Awareness Week

This week, May 1st – 7th, marks the third annual Clinical Trials Awareness Week, hosted by The Coalition for Clinical Trials Awareness (CCTA). The Coalition for Clinical Trials Awareness is a nonprofit group comprised of health care providers, patient advocates, medical researchers and industry and government stakeholders working together for one common goal - to increase public awareness about the importance of clinical trials participation. Established by the CCTA in 2015, Clinical Trial Awareness Week is observed annually the first week of May, encouraging patient advocacy organizations, medical societies, and other health organizations to rally together to raise public awareness about the importance of clinical trials and the benefits of participation.

Topics: Clinical Trials Awareness Week 2017

Posted by John Lehmann on Thu, Apr 27, 2017

IRB + 123 = Patient Protection

The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients. A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!

Topics: Patient Protection, FDA, IRB

Posted by John Lehmann on Fri, Apr 21, 2017

The Immortal Life of Henrietta Lacks

On Saturday, April 22nd, HBO will premier their film “The immortal Life of Henrietta Lacks.” We are excited to see the story becoming a film and thought we would republish a blog that we posted back in 2013 to honor the topic.

Topics: Henrietta Lacks, HBO

Posted by Brandy Chittester on Wed, Apr 19, 2017

Five Skills that Make a Great Monitor

Clinical Monitors sometimes have a challenging job; they are often on the road, trying to balance work and home life.  They juggle multiple studies from different Sponsors, have many relationships to maintain, sites to visit, and reports to write.  At IMARC we want to always provide the very best monitoring services we can.  In order to do that we must have great monitors on staff, so, what makes a great Monitor?

Topics: Clinical Monitors, Clinical Research

Posted by Kelly Jasko on Thu, Apr 13, 2017

How Patient-Reported Outcomes are Important in a Clinical Trial

Obtaining useful and significant data is paramount to a successful clinical trial; however for those studies with a limited amount of quantitative scientific data, results may be highly dependent on patient-reported outcomes (PROs). The FDA definition of a PRO is “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else”.

Topics: FDA, PROs, Patient Reported Outcomes

Posted by John Lehmann on Tue, Apr 11, 2017

A Risk-Based Monitoring Checklist

Many people are under the impression that Risk-Based monitoring equates to less monitoring, which isn’t actually the case. IMARC Research has utilized risk-based monitoring since the company was founded and we have always believed that Risk-Based Monitoring = Informed Monitoring.  In fact, if you step back and consider how you manage a clinical trial you will probably notice that you have been employing some level of risk-based methods yourself.  Maybe you have worked with one particular site many times before and you know you can count on them to deliver quality care to research subject while collecting accurate data.  Perhaps knowing this, you choose to postpone their monitoring visits until after site visits to newer less experienced sites can be made.  This is risk-based monitoring! 

Topics: Risk-Based Monitoring, Informed Monitoring

Posted by John Lehmann on Wed, Apr 05, 2017

5 Keys to Choosing a Medical Device CRO [SLIDESHARE]

 

 

Having independent oversight is critical to ensuring compliance, keeping your clinical
research trial on track and bringing your device to market faster.

For this reason, many companies hire a clinical research organization (CRO) to monitor, audit and even manage their trial. Outsourcing this work has become more common and is widely accepted throughout the industry, but it can still be difficult to turn over any or all aspects of your trial to a third party. 

Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.

How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?

This slideshare covers the five factors you need to look for when choosing one.

Topics: Medical Devices, CRO, 5 Keys, Compliance Partners

Posted by John Lehmann on Tue, Oct 24, 2017

Clinical Research Documentation - ALCOA-C

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, ALCOA-C

Posted by John Lehmann on Wed, Apr 05, 2017

How to Hire a Compliance-Minded CRO

Clinical research sponsors continue to outsource the management of their clinical trials, spending millions of dollars for a pivotal phase and significant risk medical device trial. Choosing a clinical research organization with compliance expertise will protect your investment and ensure your product is ultimately approved.

Topics: CRO, Compliance-minded

Posted by Paul Cobb on Mon, Nov 06, 2017

5 Tips for Keeping Great Principal Investigators

Dr. Robert Findling, Director of Johns Hopkins Division of Child and Adolescent Psychiatry and leading researcher in pediatric psychopharmacology, views being a principal investigator as “a privilege, not a right.” Dr. Findling has been noted as saying “with privilege comes great responsibility”. Principal investigators who subscribe to this philosophy can set themselves apart by leading the development of cutting-edge technology and novel treatments. According to 21 CFR 812.100, General Responsibilities of investigators, P.I.s are responsible for conducting research according to the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth by the IRB.

Topics: 21 CFR 812; Principal Investigator, Principal Investigators

Posted by Tracey Tytko on Thu, Mar 02, 2017

5 Tips to Survive an FDA Inspection

You just got the phone call; the Food and Drug Administration (FDA) Inspector is coming for a visit.

Are you feeling calm and prepared, or like most people in your position, are you in some stage of panic? After all, who wants someone from the federal government looking for (and inspecting!) all the things you might have done wrong?

Don’t let anxiety get the best of you – begin preparing now.

Topics: FDA BIMO inspection, FDA Inspection

Posted by John Lehmann on Tue, Feb 28, 2017

What is Good Clinical Practice?

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?

Protecting patients is at the core of clinical research and one of the ways research teams can ensure human subjects are protected is through holding up rules, regulations and standards set forth. Good clinical practice (GCP) is something that encompasses all these things because it is:

Topics: Good Clinical Practice, Human Subject Protection

Posted by Lindsey R. Friedrich on Tue, Feb 21, 2017

Maintaining Professionalism During a Conflict

Maintaining professionalism in a difficult situation is unfortunately something most professionals encounter during their career. Being able to keep calm and stay logical during these times is key to maintaining trust with a client, and helping them feel comfortable and confident to work with you to resolve the issue(s) at hand. For Clinical Research Associates (CRAs), diplomacy and tact are crucial since often they work in stressful situations where subjects’ health and safety are involved. Thus, it is important to understand the general principles that define professionalism and how to gain trust in a working relationship, maintain that trust to power through stressful situations, and “rise above the fray” when tensions are high. This blog will cover each of these aspects and will aim to provide you with the necessary tools to handle conflict and remain professional.

Topics: Clinical Research Associate, Professionalism

Posted by Melissa Wollerman on Thu, Feb 16, 2017

How a Federal Regulation is Born

Regulations are a set of legal rules that are established by a regulatory authority such as the FDA. They are required to be followed and are enforceable by legal consequences such as fines or imprisonment. The process of making a regulation can be a lengthy but important process. Federal agency priorities, industry trends, public safety, or new technology are potential reasons for creating a new rule, which can later become a federal regulation. The process of “rulemaking” is simply described: 

Topics: Federal Regulations, FDA

Posted by John Lehmann on Tue, Feb 14, 2017

Are Clinical Vendor Audits Important?

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.

Topics: Ensuring Compliance, Clinical Vendor Audits

Posted by Carla Glass on Tue, Feb 07, 2017

Revisions to the Common Rule

U.S. federal regulations governing the protection of human subjects in research have been in existence for more than 30 years. The Department of Health, Education, and Welfare first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. To promote uniformity, understanding, and compliance with human subject protections, U.S. federal departments and agencies adopted the revised version of the regulations in 1991; subpart A of 45 Code of Federal Regulations (CFR) part 46 was created. This is often referred to as the “Common Rule” or “Protection of Human Subjects Regulations”.

Topics: The Common Rule, U.S. Federal Regulations, Revisions

Posted by Carla Glass on Fri, Feb 03, 2017

Volunteering for Clinical Research: What You Need to Know About the Informed Consent Process

Medical research has led to many important medical discoveries that make our lives better. When medical research studies are completed, researchers can share the information with the medical community around the world at conferences or via peer-reviewed journals; and the results of these studies often help doctors provide better and more improved care to their patients.

Topics: Informed Consent, Clinical Research, Volunteering

Posted by John Lehmann on Wed, Jan 03, 2018

Building the Business Case for Clinical Research Training

Most clinical research study sponsors recognize that having a properly trained research staff is key to ensuring compliance and bringing their device to market faster. The question is, how do you implement an effective training program that achieves your organization’s desired goals?

Topics: IMARC University, Clinical Research Training, Building a Business Case

Posted by Katie Mitchell on Wed, Jan 25, 2017

The ICH E6(R2) Addendum - An Intro to the What and Why of the Changes (Part 1)

Since finalization in May of 1996, the Guideline for Good Clinical Practice E6(R1) produced by the International Conference on Harmonization(ICH), has provided clinical trial research with a set of procedural standards to ensure quality data and protection of human subjects. The document has continued to be a guiding presence in the industry over the past twenty years; however, increases in both magnitude and intricacy of clinical trials has prompted a need for modernization of the content. At the guideline’s inception, the vast majority of trials were paper-based, which is in stark contrast to the technological focus of today’s trials. The industry has also experienced a move toward risk-based methodologies to improve efficiency of the rapidly growing trial landscape. The universal shift toward electronic records, data capture systems and risk-management has led to changes in the conduct of trials not only to clarify the processes, but to redefine the responsibilities of the individuals executing them. For all these reasons and more the ICH has rolled-out the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).

Topics: International Conference on Harmonization, ICH E6(R2) Addendum

Posted by Mary Lewis on Tue, Jan 17, 2017

How to Prepare 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?

Topics: BIMO Checklist, FDA Audit

Posted by John Lehmann on Tue, Jan 10, 2017

Comparing Significant Risk vs. Non-Significant Risk Studies

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?

Topics: Signficant Risk, Non-Signficant Risk

Posted by John Lehmann on Thu, Jan 05, 2017

ALCOA – A Tool 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, ALCOA Checklist

Posted by John Lehmann on Mon, Jan 15, 2018

The History of Clinical Research

For research professionals involved in clinical trials, there is an immense responsibility of protecting human subjects, but history has taught us, unethical practice and disregard for the well-being of human subjects has occurred and will continue to occur.

Ensuring accurate and credible data from clinical trials and protection of human subjects is the role of every individual on the research team. The price for compromise is high; history provides an array of haunting reminders of our failure to uphold our obligation to ethical excellence in our work.

Topics: History of Clinical Research Timeline, IMARC Research

Posted by John Lehmann on Mon, Dec 05, 2016

2017 CDRH Regulatory Science Priorities

The Center for Devices and Radiological Health (CDRH) recently issued its fiscal 2017 regulatory science priorities. The list repeats some of the points highlighted in its 2016 list, while surfacing some new issues for consideration.

Topics: CDRH, Regulatory Science Priorities, FY 2017

Posted by John Lehmann on Wed, Jan 03, 2018

10 Keys For Responding to an FDA Warning Letter or Form 483

Each year, IMARC releases a whitepaper listing of the top reasons for FDA warning letters, here is the listing for 2015. Provided below are 10 Tips to consider when responding to a FDA Warning Letter or Form 483: 

Topics: Form 483, FDA Warning Letters

Posted by John Lehmann on Thu, Nov 17, 2016

Compliance with ISO 14155:2011

IMARC Research has created a new whitepaper that highlights the Guidance for Ensuring your Clinical Study is Being Designed, Executed, and Monitored in Accordance with the ISO 14155.2011 International Device Standards. The goal of this paper is to introduce some suggestions on how to set up a study for successful compliance with both the FDA regulations and ISO 14155, giving some practical advice on how these additional ISO requirements can be added.

Topics: FDA Regulations, Compliance, IMARC Whitepaper, ISO 14155:2011

Posted by Lisa Wickert on Tue, Nov 15, 2016

Subject Participation in Clinical Trials is Paramount

Obtaining useful and meaningful data is one of the goals of any clinical trial. However, in order to attain the necessary data, subject participation in clinical trials is paramount as subjects are the heart and soul of a clinical trial. One of the keys to a successful clinical trial, no matter the stage or trial type, whether it is a drug or device study, is meeting subject enrollment requirements. Understanding how the general public views clinical trials and how clinical research professionals might shape that opinion, is vital.

Topics: Subject Participation, Subject Enrollment

Posted by John Lehmann on Thu, Nov 10, 2016

Why Conduct Clinical Vendor Audits?

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.

Topics: Vendor Audits, Ensuring Compliance

Posted by Emily Haglund on Tue, Oct 25, 2016

Increased Transparency Requirements with clinicaltrials.gov

The US Department of Health and Human Services (DHHS) recently released a final rule regarding the specific requirements for the registering and results submission of clinical trials within the clinicaltrials.gov database. As previously, the final rule applies to “responsible parties” for “applicable clinical trials.” Responsible parties are frequently the sponsor of a clinical trial or principal investigator. Applicable clinical trials must meet certain criteria.

Topics: National Institutes of Health, FDA ClinicalTrials.gov, The Department of Health and Human Services

Posted by John Lehmann on Thu, Oct 20, 2016

Comparing Drug and Medical Device Clinical Trials

Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

Read on to learn the similarities and differences between drug and medical device clinical trials.

Topics: Medical Devices

Posted by John Lehmann on Mon, Nov 06, 2017

Drug and Medical Device Clinical Trials 101

Most medical professionals enjoy being on the forefront of new clinical treatments, techniques and products. Drug and device research trials are a great opportunity for those in the healthcare field to learn about and assist in the development of revolutionary ways to treat patients, before they’re introduced to the public. These studies can provide invaluable information and learning experiences to everyone involved.

The responsibility for running a clinical trial is immense, so learning as much as possible about the process is essential for clinical research professionals to effectively contribute. Read on to discover the who, what, why and how of drug and device clinical trials.

Topics: Medical Devices

Posted by John Lehmann on Tue, Oct 18, 2016

A Handy Guide to Medical Device Classifications

A clinical trial is required for all new drugs, but this is not the case for all medical devices. Medical devices start by undergoing a risk assessment in order to determine the severity of potential harm to the user and the probability of that harm occurring. Each device is assigned to one of three classes based on this assessment, and this classification dictates whether or not a clinical trial is necessary.

Topics: Medical Devices

Posted by John Lehmann on Tue, Oct 11, 2016

IMARC Research Opens New Office

IMARC Research has expanded its footprint and opened a new office in the Minneapolis area. The office is located in Minnetonka, Minnesota and will be managed by Jim Moat, Senior Clinical Specialist. He is a Certified Clinical Research Specialist with more than 26 years of experience in medical device product development, having managed all phases of clinical study – from pre-market strategy to post-market surveillance.

Topics: IMARC Research, New Office, Minneapolis Area

Posted by John Lehmann on Wed, Jan 03, 2018

A Solution for your Clinical Training Needs

Is your company struggling with the growing training needs of your clinical staff? Do you lack the staff and time to implement an effective training program? Every company understands the importance of providing training to help your staff grow, but often companies struggle to identify a solution.

Topics: IMARC University, Clinical Training

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 Wed, Jan 03, 2018

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 Wed, Jan 03, 2018

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

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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.