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Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Risk Based Monitoring

 

o Guidance for Industry-Oversight of Clinical Investigations- A Risk-Based Approach to Monitoring

 

Articles

 

o Icon Offers Risk-Based Monitoring Service For Trials

o Site Quality Management: The Revolution In Risk-Based Monitoring

o Experts: FDA Guidance On Risk-Based Trial Monitoring Most Effective for Phase II, IV

o Understanding Risk-Based Monitoring: An interview

 
 




Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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