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​​​​​​​​​​​​​​​​NLM Assessment and Registration FAQ​
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  • ​How do I determine if a protocol is applicable under the ​Final Rule or the NIH Policy?


    Applicable under the Final rule vs NIH Policy

    Applicable Under Final Rule
    		 Applicable Under NIH Policy
    Data Element
    		 Value Additional Values
    Study Type
    		 Interventional Same
    Phase II-IV
    (N/A for device trails)    		 I
    FDA Regulated Intervention Yes No
    (e.g., Behavioral Interventions)
    IND/IDE Required Yes* No
    Primary Purpose Other than "Device Feasibility" Device Feasibility
    Or
    Pediatric Post-Market Surveilliance Yes Same


    • *For any trial that is IND/IDE=No, it can still quality as applicable if either:

    • One of its associated sites is within the United States
    • The study drug is manufactured in the United States

  • Who Is Responsible for Registering Trials and Submitting Results?


    The Responsible Party for a clinical trial must register the trial and submit the results information. The Responsible Party is defined as the sponsor of the clinical trial or the principal investigator (PI) of such clinical trial.


    Responsible Party for Applicable Clinical Trials


  • When do results have to be registered and submitted?


    The Responsible Party for an Applicable Clinical Trial must submit the required clinical trial information no later than 21 days after enrollment of the first participant. In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by the Food and Drug Administration (FDA) must be submitted by the Responsible Party no later than 12 months after the Completion Date.


  • What serves as a trigger for a protocol to be sent to the NLM?


    A Site Activation Confirmation Letter serves as one of the triggers for a protocol to be sent to the NLM.


  • How long does PRS Review take?


    Once a protocol record is released to the PRS, it will be pending PRS review. Any updates made to the record while it is pending PRS Review will result in the protocol record being unreleased resetting the process. Review of the record by the Protocol Registration and Results System (PRS) can take 2-5 business days.


  • When will a protocol receive a National Clinical Trial number (NCT)?


    Once the PRS review is completed, the NCT number will be assigned to the protocol, and SIO will notify all stakeholders of the NCT number. The NCT number will also be associated to the protocol in the RSPA module. Once the record is approved and posted, updates will appear on ClinicalTrials.gov within 2 business days.​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​


  • What type of studies require oversight from DMID?


    Non-IND, Grant/Cooperative, IDCRC studies may require DMID oversight. During the NLM assessment, if the CPM or ORA respond that the protocol is a high-visibility study that requires DMID to be the responsible party, SIO proceeds to set DMID as the responsible party for this study.

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