Medical Device CRO Blog | Clinical Studies

Posted by Lauren Luzar on Wed, Sep 26, 2018

Determining Risk for In Vitro Diagnostic Studies

In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly. The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the device is classified as Class I or II, and if it is non-exempt, a premarket notification (510(k)) will be required for marketing. A 510(k) is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).

Topics: Clinical Studies, In Vitro Diagnostics

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 Sandra Maddock on Wed, Mar 04, 2015

5 Reasons Patients Withdraw from Clinical Studies

Topics: Clinical Studies, Carmen J. Gonzales, ACRP, Patient Withdraws

Posted by Stephani Hulec on Wed, Mar 04, 2015

New Symptom in Clinical Studies: The Nocebo Effect

Most people are familiar with the term placebo effect, in which patients experience beneficial symptoms associated with a specific treatment, even when they are given an ineffectual treatment, or “placebo”. Recently, this New York Times article discussed the opposite medical phenomena known as the nocebo effect. The nocebo effect is defined as:

Topics: Clinical Studies, The Nocebo Effect, New York Times, New Symptom

Posted by Sandra Maddock on Wed, Mar 04, 2015

5 Reasons Patients Withdraw from Clinical Studies

In a clinical research, patients are the most important key to a study. Subject retention is vital for data integrity, and lack of subject participation can have costly delays for the Sponsor. Since research sites spend a great deal of time and effort finding qualified subjects, they should also be equipped with reasons subjects withdraw to help prevent this from happening.

Topics: Clinical Studies, Reason Patients Withdraw, Carmen R. Gonzales, JD, ACRP

Posted by John Lehmann on Tue, Oct 24, 2017

Outsourcing IRBs – Not As Simple As You Think

During a recent monitoring visit, I came across a scenario that challenged my efforts to ensure compliance with the Institutional Review Board’s (IRB) policies. For background, an East Coast University/Hospital has a new area of outsourcing for the studies that are being conducted at their institution. The local IRB reviews all Phase I/ II studies and all studies that are funded by the National Institutes of Health (NIH). Phase III and IV trials are outsourced to a central IRB.

Topics: Clinical Studies, Study Coordinator, Clinical Monitoring, Outsourcing IRBs

Compliance In Focus

Topic

Newest Post

Determining Risk for In Vitro Diagnostic Studies

Final Rule for Clinical Trials Registration and Results Submission

5 Reasons Patients Withdraw from Clinical Studies

New Symptom in Clinical Studies: The Nocebo Effect

5 Reasons Patients Withdraw from Clinical Studies

Outsourcing IRBs – Not As Simple As You Think

clinical research Training requirements

SOCIAL CHANNELS

Connect

Compliance In Focus

Topic

Newest Post

Determining Risk for In Vitro Diagnostic Studies

Final Rule for Clinical Trials Registration and Results Submission

5 Reasons Patients Withdraw from Clinical Studies

New Symptom in Clinical Studies: The Nocebo Effect

5 Reasons Patients Withdraw from Clinical Studies

Outsourcing IRBs – Not As Simple As You Think

clinical research Training requirements

STAY INFORMED

Subscribe to our blog

SOCIAL CHANNELS

Connect