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All FDA Regulated Industry
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Clinical Compliance Best Practices & Articles
This section contains Best practices for processes in Clinical industry. Browse this section to find clinical regulation related articles, best practices published by many world renowned experts. View compliance trainings and standards for enhanced knowledge of clinical industry.
Most Read Articles  
Clinical Trials in Brazil: trends and experiences
Research Involving Human Subject Regulations 45 CFR part 46 - Decision Charts
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Compliance Best Practices for Clinical Research
Adverse Event Reporting to IRBs – Best Practices to Follow
The Role and Responsibilities of Ethics Committees in Clinical Research: What are the Best Practices?
General Articles
Strategies on how to Minimize the Rise of Enrollment Violations in Clinical Trials
Clinical Trial Compliance: New Focus on IRBs
Volunteers for drug trials hard to find
Regulations & Guidances
FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies
FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection
FDA 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
Improving Access to Clinical Trials Act of 2009
Compliance Standards for Clinical Research
Validation Master Plan
Validation master plan for equipment hardware, computer systems, networked spreadsheet applications and legacy systems. Framework and starting point for all other validation documents.The product includes forms, checklists for quick start and implementation.

Price: $90
Method Validation
Price: $79
QVD Protocol and Report Preparation
Price: $99
Monitoring of Clinical Trials
Price: $29
Compliance Trainings
The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
On Demand Access Anytime
Clinical Statistics for Non-Statisticians. An Introduction to Statistical Concepts and Practices
On Demand Access Anytime
How to Write an ICH-Compliant Clinical Study Report
On Demand Access Anytime
FDA Clinical Trial Requirements, Regulations, Compliance and GCP (Good Clinical Practice)
On Demand Access Anytime
GCP and FDA Regulations with regard to Investigator Responsibility - How to get your PI more involved in the clinical Research process
On Demand Access Anytime
Designing a Pediatric Clinical Trial - ethical consideration and how to manage per regulatory requirements
On Demand Access Anytime
Contributing Authors/ Experts
Ornat katzir , Clinical Research Consultant, IQCR
Elizabeth E Bodi, Associate, Halloran Consulting Group
Teresa Nelson, Biostatistician, Technomics Research