Basics - Part 22 - Essential Documents

Guideline for good clinical practice E6(R2):
www.ema.europa...
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic):
www.ema.europa...
What everybody should know about Clinical Trials!
Without clinical trials, we wouldn’t have any vaccines, treatments for cancer, heart disease, diabetes and many others. What should everybody know about Clinical Trials? How are pharmaceuticals and medical devices developed? This is our new video of our series about the basics of clinical trials to give you some answers. Part 22 - Essential Documents is presented by our expert Kelsey Crossman.
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[@jnaneshnb9371]

Very informative, thank you.

[@fredrikh9299]

Thanks Kelsey!

[@nursecarter28]

Very nice clinical trials training.

[@dranthonyojo]

Thank you much! This was helpful!

[@gabrielagarcia4202]

Great job, thank you!

[@raunakmukherjee5468]

Thank You, this is very helpful. I have one doubt. Please clear it.
Why does the treatment allocation & decoding document and audit certificates required after completion of Clinical Trial?

[@JL-nb1yc]

I have one big question. I have been producing charters for a CRO for years. I have always been told that a charter is required for FDA permission to recruit patients. Can anyone comment on this?