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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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    Central Florida Chapter - Annual Planning and Development Event! 20 November 2014

    The Central Florida Chapter i s having an Annual Planning and Chapter Development Event! SAVE THE DATE!...

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    How are we doing as research Sites? Let's allow our patients to tell us....

    As 2014 starts to wind down; do you ever wonder how your site is doing? The patient's perspective is paramount to none...

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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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LATEST DISCUSSIONS

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    RE: PI Signature on ICF

    Posted in: Clinical Research Professionals...

    21 CFR 50.27 (a) stipulates that consent forms be approved by the IRB and signed and dated by the subject or the subject's legally authorized representative (LAR) at the time of consent. ...

  • Jacqueline Stader

    RE: PI Signature on ICF

    Posted in: Clinical Research Professionals...

    There isn't any regulation that states the PI must sign the ICf or that there is a timeline for signing. However what you will find in both FDA and ICH guidance is the person who is conducting...

  • Erica Heath

    RE: PI Signature on ICF

    Posted in: Clinical Research Professionals...

    First, take your question to your IRB. Before each person's signature space there should be a statement about what that statement means. The subject, of course, is indicating agreement...

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    RE: SIV

    Posted in: Clinical Research Professionals...

    If you had a SIV conducted before a contract was in place how would either side be sure it was a worthwhile use of resources - if the sides never could agree on terms. Same for IRB -...

  • Mark Blum

    RE: SIV

    Posted in: Clinical Research Professionals...

    Hi Karen: From a regulatory standpoint you can have a meeting to discuss the study any time you want. A site initiation visit per se is not required by the regulations, but standards...

CLINICAL RESEARCH NEWS

FDA approves Xtoro to treat swimmer’s ear

The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.

FDA approves first pathogen reduction system to treat plasma

The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).

FDA announces Pharmacy Compounding Advisory Committee members

The U.S. Food and Drug Administration today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

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