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Sending Secure E-Mail at MedStar

It is important that all associates understand when it is necessary to encrypt the data Read More »

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Extension of the Effective Date of the Single IRB Policy for NIH Studies

As announced in the July edition of Focus, the National Institutes of Health (NIH) has Read More »

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Important Updates to Common Rule for Clinical Trials

U.S. Department of Health and Human Services (DHHS) and 15 other federal agencies on January Read More »

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New Final Guidance from the FDA on Electronic Informed Consent

Final guidance was published on December 15 by the U.S. Food and Drug Administration (FDA) Read More »

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Reporting Compliance Concerns

MedStar Health is committed to supporting the requirements of a high-reliability organization. In order for Read More »

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New Policy on Good Clinical Practice Training for NIH-Funded Clinical Trials

The NIH has released a new policy on training in Good Clinical Practices (GCP) for Read More »

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New HHS Final Rule and NIH Policy on Releasing Study Results on ClinicalTrials.gov

Released on September 16, the U.S. Department of Health and Human Services (HHS) issued a Read More »

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New HHS Guidance for HIPAA and Ransomware

The U.S. Department of Health and Human Services (HHS) has released a new guidance on ransomware and Read More »

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Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

The National Institutes of Health (NIH) has released a new policy, effective in 2017, to Read More »

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FDA Finalizes Three Guidances on Expanded Access to Investigational Drugs

Expanded access is the process by which investigational treatment options are made available to patients Read More »

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