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Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

Expedited Review

Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

Clinical Investigations

 

o Guidance for Industry Electronic Source Data in Clinical Investigations (PDF)

o Electronic Source Documentation in Clinical Investigations (PDF)

 

21 CFR PART11

 

o Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF)

o 21 CFR part 11, Electronic Records; Electronic Signatures

 
 




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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