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

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.

Risk Management in Clinical Research

Risk Management in Clinical Research

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

Sponsor-Investigators: Force the Formality

Sponsor Investigators   Force the Formality

Sponsor-Investigators are uniquely dedicated and invested in clinical research. In a previous blog post, IMARC described how Sponsor-Investigators have to wear two hats and follow two sets of regulations.

Protocol Development - Is this Medical Test Really Necessary?

Protocol Development     Is this medical test really necessary

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

Cybersecurity in Medical Devices: New FDA Guidance

Cybersecurity in Medical Devices   New FDA Guidance

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

1944-1974 – Human Radiation Experiments

Human Radiation Experiments

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 calendar year.

Can Improving Quality in Device Trials Shorten Time to Market?

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. 

Modern companies cannot operate today without a quality system and if they are sponsoring clinical research, oversight of clinical studies should fall under their quality system. CDRH conducts on the order of 300 Bioresearch Monitoring (BIMO) inspections per year and annually publishes details of its inspectional findings in medical device trials.

Battle of the Sexes - Eliminating Gender Bias in Research

Eliminating Gender Bias in Research

When it comes to the Battle of the Sexes you may be surprised to hear this competition is a popular one in the field of health research. On Tuesday, September 22, 2014 the National Institutes of Health (NIH) announced that it will be distributing $10.1 million in grants to scientists and research facilities studying a host of topics, from drug addiction to migraines.  These funds are intended to help support the inclusion of more research subjects, particularly females, in studies that require a little more representation of the XX chromosomes in their laboratory subjects. This means the participation of more female animals, even cell lines, in research laboratories.  The remainder of the awarded money will be used to supplement analysis of gender differences in the studies’ resulting data.

FDA New Guidance on Informed Consent: Updates to Required Elements

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In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

Why Do We Need to Audit?

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.

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