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    Payment for screen failures

    I have found that Sponsors use the screen failure payment limit as a safety net so that they are not paying out random...

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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...

    2 people recommend this.



In the Know


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    RE: Patient Perception

    Posted in: Clinical Research Professionals...

    I find that our subjects enjoy taking part in research. It is altruistic, especially in studies that are not even intended to benefit the subject except in that they have been able to increase...

    1 person recommends this.
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    RE: Research Patient Survey-Available

    Posted in: Clinical Research Professionals...

    My understanding of this survey is that it is for QA purposes in regards to a subjects participation in research and not in and of itself a research study. I have to agree Erica.

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    Course of Event for AEs

    Posted in: Clinical Research Professionals...

    Hello: On a current study, the sponsor is asking sites to define a course of event for AEs as "single episode", "continuous", or "intermittent". I understand the difference between continuous...

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    RE: Time of signature on ICF

    Posted in: Clinical Research Professionals...

    Hi Michelle, We actually include a statement in our source documentation that consent was obtained before any study related procedures were performed.

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    RE: Patient Perception

    Posted in: Clinical Research Professionals...

    I too struggle with the word "Research" ----I see, at least Phase III studies, as being "participating in clinical trials" for subjects/patients. We have started referring to our dept. as...


First vaccine approved by FDA to prevent serogroup B Meningococcal disease

The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

FDA approves new treatment for rare form of hemophilia

The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).

FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic

The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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    Cynthia Jordan

    Birmingham, AL

    332 Points

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    Holly Wadkins

    University of Rochester
    North Chili, NY

    101 Points

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    Judy Guerreiro

    Northwestern Medicine at Central Dupage Hospital
    Winfield, IL

    99 Points