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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A New Job Position Is Emerging In Clinical Research and It Could Be Great For The Industry!

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Clinical Trial Educators may be a new option for Contract Research Organizations (CRO’s) which will help improve recruitment for their sites. It is possible that as the larger CRO’s begin to make use of Clinical Trial Educators, other CRO’s will follow suit.

The new method of recruitment may have emerged.

The new method of recruitment may have emerged.

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What Technology Does A Research Clinic Need And Can Social Media Help With Recruitment?

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Operating a research site does not require extravagant software. There are simple, low budget options that protect and are compliant with patient privacy regulations.

The latest software for clinical trials does not have to be the most expensive.

The latest software for clinical trials does not have to be the most expensive.

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Does Your PI Need To Be Board Certified In Order To Conduct A Clinical Trial

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Most Sponsors currently do not require a Principal Investigator (PI) to be board certified. However, Sponsors could easily become more selective, and work only with board certified physicians, during the current period of low research study supply.

A PI doesn't have to be Board Certified, but selective sponsors may require certification.

A PI doesn’t have to be Board Certified, but selective sponsors may require certification.

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Standard Of Care Clinical Trials

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The frequency of standard of care studies appears to have increased recently. While these studies may not pay as much as other types of studies, they also require less attention.

Standard of care studies help obtain useful information from patients already undergoing specific treatments.

Standard of care studies help obtain useful information from patients already undergoing specific treatments.

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How To Structure A Study Coordinator Salary and Bonus

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Young clinical research sites may encounter a situation where their research team either has little experience or adequate levels of experience.  Either approach can work but will require different levels of involvement on behalf of the site owner.

Having a game plan during the early stages of clinical research can help a research site prepare for success.

Having a game plan during the early stages of clinical research can help a research site prepare for success.

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