In short, it comes down to whether the researcher is assigning participants to receive an intervention so that they can study how that intervention relates to a health outcome, or if they are observing health outcomes in patients who already naturally belong to a group of interest (i.e., have a certain condition, are receiving a certain treatment as part of standard of care).
If you are registering an interventional trial, you'll need to select the Primary Purpose for that trial from a pre-defined list within the Study Design module. Refer to these definitions below when selecting the Primary Purpose for your interventional study.
One of the most common sources of QC comments that cause ClinicalTrials.gov records to be rejected is the Outcome Measure Time Frame field. The requirements for Outcome Measure Time Frames can be summed up as: 1) Outcome Measure Time Frames need to be specific, and 2) unless you are measuring a value of change over time, Time Frames for Primary Outcome Measures must have only one time point.
What if your Primary Completion Date occurs before your Study Completion Date, i.e., because you have longer term follow-up for Secondary Outcome Measures and/or Adverse Events? Does that mean you’ll be facing a results time-crunch or even late results because of your longer-term data collection period for Secondary Outcome Measures?
The “Active, Not Recruiting” status in ClinicalTrials.gov is often misinterpreted. This status should only be used to indicate that “participants are still receiving an intervention or being examined, but new participants are not currently being recruited or enrolled”.
In some cases, you may be required to upload documents to ClinicalTrials.gov. such as the study Protocol and Statistical Analysis Plan (SAP) or the Informed Consent Form. To post documents to ClinicalTrials.gov, follow these instructions.
What if you have a study that is suspended for a long period of time, and a decision is later made to terminate it? What if you are required to report results, but the decision to terminate comes too late for you to report results on time? Here's what to do.
ClinicalTrials.gov will always reject nonmeaningful placeholder results data with the following comment: "Major Issue: One or more numbers in the table appear to be nonmeaningful placeholders that do not reflect data collected during the study."
The Revised Common Rule (45 CFR 46) requires that an informed consent form must be posted on a public federal website (i.e., ClinicalTrials.gov) for any clinical trial conducted or supported by a federal department or agency (such as NIH).
ClinicalTrials.gov Outcome Measure Time Frames are the specific time points at which you are collecting data for (measuring) the outcome. If the Time Frames are not entered as a specific time points, the record will be rejected with the following comment: ”Major Issues: The Time Frame does not appear to be specific and/or in the correct format.”
Many funders require registration and/or results reporting to clinicaltrials.gov for studies that meet their definitions of a clinical trial, but the Patient-Centered Outcomes Research Institute (PCORI) is a little different, in that their policy also requires registration and results reporting for observational studies.
The number of participants affected is the number of participants in that arm or group who actually experienced that category or type of adverse event.
The number of participants at risk is the total number of participants who were monitored for those adverse events in that arm or group.
For problems in REGISTRATION submissions or updates, correct or address issues within 15 days of electronic notification of the issue.
For problems in RESULTS submissions or updates, correct or address issues within 25 days of electronic notification of the issue.
In addition to the issuing of a Notice of Noncompliance, which remains permanently public, FDA is authorized to seek civil money penalties of up to $10,000 per day, or take actions such as injunction or criminal prosecution, for failure to submit required information to ClinicalTrials.gov.