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The ACRP Online Community connects you to thousands of your industry colleagues through interactive eForums and a searchable Member Directory, and puts you in touch with hundreds of industry resources that can help you in your day-to-day job.

This social networking-style website is a vital resource for clinical research professionals like you looking to connect with others in your field and improve your job performance.

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RECENT BLOGS

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    Is it necessary for us to gain the certification?

    I am an applicant of ACRP certification. I am really NOT satisfied by certification program. I am wondering whether it...

    1 person recommends this.
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    The Patient Experience Survey

    We are inviting the ACRP members to extend this survey to their research patients. This initially started as a Site...

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    Is it ok not to report an SAE within 24 hours

    Clinical Research Professionals Open Forum

    I know, I know all SAE's should be reported in 24 hours, but I had to say something to get your attention :-). Seriously...

    1 person recommends this.

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LATEST DISCUSSIONS

  • Julie Omohundro

    RE: Applying for FDA IDE

    Posted in: Device eForum

    It might not be necessary to apply to the FDA for an IDE, but they will still need an IDE. Under 21 CFR 812.2(b), if a certain set of criteria are met, then the study will "considered to"...

  • Erica Heath

    RE: Applying for FDA IDE

    Posted in: Device eForum

    PS - Great example Mark Erica ---

  • Erica Heath

    RE: Applying for FDA IDE

    Posted in: Device eForum

    Short answer: No, they don't need to file anything with FDA. But, long answer.... they may have a little way to go to get agreement. There is no such category as nonsignificant or non...

  • Mark Blum

    RE: Applying for FDA IDE

    Posted in: Device eForum

    The law requires that determination about whether a device is nonsignificant risk be made by an IRB if the FDA doesn't make that determination. The evaluation depends not only upon the device,...

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    RE: Applying for FDA IDE

    Posted in: Device eForum

    I searched goniometer Online. It appears to be a measurement device for spinal lateral movement. It is not an implant. Therefore not a significant risk device, so an IDE is not necessary....

CLINICAL RESEARCH NEWS

FDA releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments

Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.

FDA approves Trulicity to treat type 2 diabetes

The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

FDA approves Movantik for opioid-induced constipation

The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

More News

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GETTING STARTED

STEP ONE
Login with your Username and Password.

STEP TWO
Customize your Profile and Preferences.

STEP THREE
Adjust your eForum notifications settings; go to Discussions, click on My Subscriptions.

STEP FOUR
Start a conversation; Post a Message in one of the Discussions.

STEP FIVE
Start networking; go to the Directory and Find a Member to connect with.

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PAST WEEK'S TOP CONTRIBUTORS

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    Tim Benjamin

    TreatmentTrials.com
    London

    224 Points

  2. photo not available
    Joanna Gwin

    Athens Cardiology
    Athens, GA

    131 Points

  3. photo not available
    Julie Omohundro

    Class Three, LLC
    Research Triangle Park, NC

    99 Points