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Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric post-market surveillances of a device product. ACTs generally include interventional studies (with one or more arms) of FDA-regulated drug, biological, or device products that meet one of the following conditions:
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For new clinical trials, submission requirements are triggered by enrollment. The PI must submit the required information no later than 21 days after the first participant is enrolled.
Records must be updated no less than once every 12 months, even if there are no changes to the information.
Results Reporting:
The PI of the clinical trial is responsible for posting basic study results at the conclusion of the study – within one year of the overall study completion date.
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How To: | If you have a study that meets the either the FDA or NIH definition of a clinical trial:
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Resources | Organization Policy on Registration of Clinical Trials: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/103_25.html Registration of Clinical Trials on ClinicalTrials.gov: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/clinical_trials.html ClinicalTrials.gov site: https://clinicaltrials.gov/ct2/about-site/background FDA Information: https://clinicaltrials.gov/ct2/manage-recs/fdaaa NIH Information: https://grants.nih.gov/policy/clinical-trials/definition.htm ICMJE Recommendations: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
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Contacts | Miye Schakne, Research Compliance Officer mschakne@jhuregisterclinicaltrials@jhmi.edu | ||||
Related Links |
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