Why Do I Need to Register My Trial and Submit Results?

Why Do I Need to Register My Trial and Submit Results ?

Required by Law

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to (e.g.,ClinicalTrials.gov), in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017. For more information on the Final Rule:

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. The law applies to certain clinical trials of drug, biological, and device products and has been in effect since September 27, 2007.

By |2019-09-20T00:06:42+01:00March 15th, 2016|Ethic|0 Comments

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