Does my trial need Human Subjects Review Board approval before I enter
it into ClinicalTrials.gov?
You may register your trial in ClinicalTrials.gov prior to getting approval from your human subjects review board (i.e., institutional review board or ethics committee), provided the trial is not yet recruiting. Before the first patient is recruited, board approval must be obtained and the protocol record updated accordingly.
Can protocol information be transferred
electronically to ClinicalTrials.gov?
Yes. This option is available in the PRS as an HTTP upload of an XML formatted file. Apply for a PRS account and then (after logging into the PRS) refer to the online User's Guide for information on XML upload.
Can a data provider have multiple user accounts?
Yes. When sponsors or their representatives register to become a PRS data provider, they will be given information on use of the PRS, including instructions for creating additional user accounts.
Is there a charge for listing studies in ClinicalTrials.gov?
No, there is no charge. ClinicalTrials.gov is a service of The U.S. National Institutes of Health (NIH), provided through its National Library of Medicine (NLM).
Can our organization list the results of a trial on our ClinicalTrials.gov record?
ClinicalTrials.gov now accepts submission of "basic results" information. Information is submitted in several modules, including participant flow, baseline characteristics, and outcomes. For more information visit: http://prsinfo.clinicaltrials.gov/fdaaa.html We also encourage organizations to list citations to peer-reviewed publications that include results from their clinical trials in the protocol section of the record. You can do this by providing the unique PubMed Identifier (PMID) of an article or by entering the full bibliographic citation n the Citations field on a ClinicalTrials.gov record through the PRS. In addition, when available, we encourage you to provide a link to the appropriate approved drug page at FDA's Drugs@FDA web site in the Links field.
Finally, if you have results posted on your own web site, you may link your ClinicalTrials.gov record to that page, provided that it clearly identifies your organization.
We have our own registry. How do we transfer data to ClinicalTrials.gov?
If your registry is a single sponsor registry run by the sponsor, then this process is straightfoward. Apply for an organizational account with us, format your data into the appropriate XML structure, and upload the data to our data entry site. It is important that you only provide the data for which your organization is the lead sponsor.
If your registry contains studies from multiple sponsors, then please send us an email at firstname.lastname@example.org with a brief description of your registry and explain what sponsors are included in your registry. ClinicalTrials.gov works with sponsors and other registries to minimize multiple registrations of the same data.
Trials were registered within our own registry and then transfered
to ClinicalTrials.gov. ClinicalTrials.gov shows the date of
initial registration as the date of transfer rather than the date
of registration within our registry. How can we change
the date of initial registration to reflect the date the trial
was first registered in our own registry so that we can meet the
deadlines specified by the International Committee of Medical
Journal Editors (ICMJE)?
We define the initial registration date as the date the trial was registered with ClinicalTrials.gov. We cannot change this date based on registration with some other registry. We suggest that you work to streamline the registration process so that there is minimal time delay between registration within your registry and the transfer of the data to ClinicalTrials.gov. For trials that have already been registered, we suggest that you provide trial registrants with a dated receipt from your registry which they could provide to journal editors if requested.
Where do I send additional questions?
Questions may be sent to email@example.com
|U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894|
|National Institutes of Health, Department of Health & Human Services|