Who Reports SAE’s and Protocol Deviations To The IRB In A Clinical Trial?

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The role of Clinical Research Associates (CRA’s) during events such as protocol deviations, adverse events, and Serious Adverse Events (SAE’s) is discussed.  While CRA’s do not report these events, they are responsible for ensuring that the investigator successfully communicates to the Institutional Review Board (IRB).

While CRA's are not responsible for reporting to the IRB, they are responsible for ensuring that reports are submitted by the investigator.

While CRA’s are not responsible for reporting to the IRB, they are responsible for ensuring that reports are submitted by the investigator.

 

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What Are Some Important Clinical Research Site Close Out Visit Items

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This video discusses common tips for closing a clinical research study. Essentially, all research material must be prepared for in the event of an FDA audit.

Sponsors ensure that their documents will be stored properly, in the event of an FDA audit.

Sponsors ensure that their documents will be stored properly, in the event of an FDA audit.

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Using FaceBook Ads To Recruit Clinical Trial Study Participants

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This video describes useful advertising strategies that do not require IRB (Institutional Review Board) approval. These type of advertisements must not include any details pertaining to any specific study.

Even when IRB approval is not available, advertising through Facebook may still be possible.

Even when IRB approval is not available, advertising through Facebook may still be possible.

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How To Recruit For A Clinical Trial That You Had No Business Accepting

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Advertising for a new study may become complicated when sponsor restrictions are applied. This video discusses ways of recruiting with such restrictions.

Even with strict  advertisement requirements, some loopholes may be available.

Even with strict advertisement requirements, some loopholes may be available.

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Whats A Good 30 60 90 Day Plan For A Brand New Clinical Research Hire

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Different expectations for different types of new employees are discussed. Suggested goals for a Research Coordinator, Certified Research Associate (CRA), and Patient Recruiter are explained.

Do not be afraid to go up one notch in excellence.

Do not be afraid to go up one notch in excellence.

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How To Deal With Combative Monitors,Set Up A Profitable Clinic, and What Makes A Good Coordinator

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For those interested in entering the field of clinical research, you may be interested in this interview I recently conducted with a clinical research coordinator. We discussed being organized, knowing the protocol, how to act professionally, use your people skills effectively, and maintain the study participant’s safety at all times. Also included are important considerations before opening a Site Management Organization (SMO) or a standalone research clinic.

CAREER CHOICES

Career choices are never easy to make.

 

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