'Issue Resolution Techniques: R.E.S.E.A.R.C.H. Skills' Course Overview:

Four hours of Education for Clinical Trial Auditors, Monitors and Investigators.

The Norton Method R.E.S.E.A.R.C.H.™ Skills Program are field-proven techniques to increase accuracy and comprehensiveness when confronted with the complex task of answering, examining, and determining the necessary follow-up to established noncompliance issues. The program provides a framework for ensuring issue resolution and establishing case development evidence for severe noncompliance.

Actual step-by-step case studies are examined in detail, which include concerns identified with three research entities:
a. Contract Research Organization
b. Phase 1 Facility Inspection
c. Phase 3 Clinical Data Audit

Global Course Objectives:

R.E.S.E.A.R.C.H. ™ is an eight step process to provide step-by-step investigative skills for handling noncompliance issues, suspect data, or reporting scientific misconduct.

The program is structured to implement proper documentation and assessment of events so that occurrences can be objectively evaluated and reported.

Removes personal reactions and view points that may interfere with proper assessments of events.

Skill-Based Training Program Deliverables:

1. Distinguish and implement the Norton Method R.E.S.E.A.R.C.H.™ Skills Program eight step process.
2. Recognize and implement critical thinking skills managing complex clinical trial issues.
3. Process step-by-step investigative and auditing skills for processing critical findings.
4. Learn communication skills for relaying difficult findings in a professional and concise manner.
5. Learn trending factors and factoring by three (3X).
6. Distinguish internal issue sources (triggered responses):
- Responding from internal prompt
- Examining different sensory pathways
7. Distinguish external issue sources:
- Visual clues through review
- Reviewer’s baseline
- Verbal cues (one of the hardest skills to learn)
- Responding by listening
8. Utilize the principles of the R.E.S.E.A.R.C.H.™ Skills Program to establish regulatory case development.
9. Develop auditing and monitoring skills for securing compliance and identifying noncompliance.
10. Examine global recommendations for correcting clinical trial noncompliance.

4 hours of Education for Clinical Trial Auditors, Monitors and Investigators.
4 Contact Hours or 0.4 CEUs
$175.00