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Compliance In Focus


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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 Danielle Sas on Wed, Mar 04, 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: FDA, Clinical Research, IRB, Consent, 21 CRF 50.25

Clinical Research Training Requirements
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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.