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Free Newsletter Sign Up Checklist Helps Navigate New Reporting Rule

Dec. 22, 2016, 7:49 PM

Clinical trial sponsors worried about a new rule set to kick in Jan. 18 now have a checklist to determine if a specific study must comply with tougher registration and reporting requirements.

The checklist is designed to help sponsors and investigators navigate the rule and avoid fines that run up to $10,000 a day for Food and Drug Administration-regulated trials. National Institutes of Health-funded grantees could have their grants terminated and noncompliance may affect their ability to secure future funding under a related NIH policy.

The Checklist for Evaluating Whether a Clinical ...