is being presented by Katherine Norris, Spectranetics & Kim Life, Life Compliance Solutions and airs on Tuesday, August 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Affordable Care Act has survived Supreme Court scrutiny and the physician payment sunshine provisions are set for implementation beginning in January 2013. As the timeframe for implementation narrows and final regulations still await reporting companies, pharmaceutical, medical device and biotechnology firms are primed to implement or refine approaches to recording, tracking, and reporting aggregate payments.
While money spent, per physician, on gifts, honoraria, consulting fees, food, research, continuing medical education and clinical investigator payments will be made public at the federal level for the first time in 2014, many states have existing requirements that have provided testing grounds for methodologies over the last several years. This audio conference presentation focuses on the myriad challenges facing firms at all stages of implementation, including selecting a vendor for your reporting solution, preparing your systems and implementation, auditing and monitoring.
Thursday, August 23, 2012
Thursday, August 16, 2012
Implementing the FDA Guidance on Investigator Responsibility
is being presented by Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant and airs on Wednesday, August 22nd, 2012. For more details or to register, please visit our site at http://www.fxconferences.com/Implementing-the-FDA-Guidance-on-Investigator-Responsibility-P1009.aspx
It's been some time since FDA released its guidance for industry on investigator responsibilities, but it remains important for investigators, study coordinators, and sponsor staff to regularly train on its content to ensure safe, high quality, efficient, and less costly clinical study conduct. With many studies, time is wasted on “cleaning up” study documentation. However, if all research staff members understand FDA’s current thinking on investigator responsibility, it becomes easier to collaborate in the subjects’ best interest and produce better study results.
This audio conference is intended help investigators and sponsors avoid FDA Form 483 findings and Warning Letters, highlighting what constitutes adequate investigator supervision, appropriate task delegation and adequate study training. Our speaker provides insight and guidance to assist investigators in developing or enhancing their plans for supervision and oversight of clinical trials. After attending the presentation, sponsor staff will be able to better identify robust investigator plans and understand sponsor responsibilities described in the guidance.
The presentation also reviews the protection of rights, safety and welfare of study subjects by providing reasonable medical care necessitated by clinical trial participation, reasonable access to medical care, and importance of avoiding protocol violations that present unreasonable risks for subjects.
It's been some time since FDA released its guidance for industry on investigator responsibilities, but it remains important for investigators, study coordinators, and sponsor staff to regularly train on its content to ensure safe, high quality, efficient, and less costly clinical study conduct. With many studies, time is wasted on “cleaning up” study documentation. However, if all research staff members understand FDA’s current thinking on investigator responsibility, it becomes easier to collaborate in the subjects’ best interest and produce better study results.
This audio conference is intended help investigators and sponsors avoid FDA Form 483 findings and Warning Letters, highlighting what constitutes adequate investigator supervision, appropriate task delegation and adequate study training. Our speaker provides insight and guidance to assist investigators in developing or enhancing their plans for supervision and oversight of clinical trials. After attending the presentation, sponsor staff will be able to better identify robust investigator plans and understand sponsor responsibilities described in the guidance.
The presentation also reviews the protection of rights, safety and welfare of study subjects by providing reasonable medical care necessitated by clinical trial participation, reasonable access to medical care, and importance of avoiding protocol violations that present unreasonable risks for subjects.
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