Falsifying Data in Clinical Trials: What to Report? - Online Webinar

Thursday, Mar 30, 2017 at 10:00AM - 1:00PM

Event Details

Falsifying data in clinical trials is also considered data fraud. When data fraud occurs there are most likely other unreported or undetected misconduct that occurred within a clinical trial. This leads to poor, unreplicable results. When results cannot be replicated, questions arise about why a trial was conducted and what types of risks or harms were the participants exposed to. Additionally, poor data collection eliminates the possibility of being able to prove or disprove the hypothesis leaving the research question unanswered and possibly leaving a valuable solution to a problem unused.

Objectives Of The Presentation
This training program will help attendees understand the regulatory expectations when it comes to identifying what and where to report when data is a falsified.
  • What is research integrity?
  • Definitions for falsification, fabrication, and plagiarism
  • What types of problems are created?
  • What should be reported?
  • Where should those reports go?
  • Who monitors and governs research integrity?
Why Should you Attend
The recommended and required contents of the trial master file (TMF) continue to be a concern for clinical trial professionals. All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs however many are not clear on the regulatory expectations. This course will provide participants with an understanding of the site and sponsor regulatory expectations when it comes to the TMF.

Participants will learn what is required of a Trial Master File for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor. Also, Attendees will learn which documents are essential, and which ones are not necessary in the event of an FDA audit.

Areas Covered
  • NIH
  • Office of Research Integrity
  • What happens with complaints?
  • Inquiry
  • Investigation
  • Adjudication
Who will Benefit
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • New Clinical Research Coordinator positions (1-2 years)
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations , Clinical Research Associates, Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
  • Anyone responsible for handling trial documentation or quality assurance activities.
For Registration

Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts March 30, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896