Scientific Misconduct/Suspected Fraud CONTENT Package

This comprehensive package includes a content reference article, corporate policy template, powerpoint presentation, and trainer instructional notes. Includes:

➢1. Suspected Fraud and Misconduct in Clinical Studies (Content Reference Article)

Click here to view complimentary content

➢2. Detection, Reporting and Investigation of Scientific Misconduct (Corporate Policy Template)

➢3. Scientific Misconduct/Suspected Fraud (PDF PowerPoint Training Presentation)

➢4. Scientific Misconduct/Suspected Fraud (Trainer Instructional Notes)

1. Suspected Fraud and Misconduct in Clinical Studies (Content Reference Article)

Click here to view complimentary content

This 23 page article serves as a cradle to grave GUIDE for critical aspects of suspected fraud and misconduct in clinical trials. Subject matter content includes:

➢Types of fraud

➢Methods of detection

➢Indicators of fraud

➢Computerized systems and fraud

➢Hard to locate fraud

➢Factors which lead to fraud

➢How FDA manages and punishes fraud and misconduct

➢The clinical hold

➢Warning letter examples

➢Discovery and reporting of fraud and misconduct

➢FDA regulations: 21 CFR 312.56 (b)

➢Application integrity policy

➢Clinical investigator and NIDPOE

➢Study protocol violations can represent study misconduct

➢Practical tips for the prevention of fraud

➢FDA form 1572-statement of investigator

➢Noncompliance with FDA regulations

➢How to detect serious fraud and misconduct investigations

➢U.S. agencies who oversee suspected fraud and misconduct investigations

➢Suspected fraud-related questions to ask

➢The impact of fraud and misconduct

➢…and more

2. Detection, Reporting and Investigation of Scientific Misconduct (Corporate Policy Template)

This three (3) page corporate policy outlines the responsibilities of your company personnel if questions should arise regarding scientific integrity or misconduct within your company’s GxP functions. This policy applies to all your company’s employees and contractors.

➢Defines key terms

➢Defines types of scientific misconduct

➢Detection of scientific misconduct

➢And more…

3. and 4. Scientific Misconduct/Suspected Fraud (PDF PowerPoint Training Presentation and; Trainer Instructional Notes)

13 slide PDF PowerPoint Training Presentation based on the subject matter presented in the reference content article above. This PDF ready made presentation provides “core” subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain 20+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

Scientific Misconduct/Suspected Fraud CONTENT Package is only $119.00