Please see the message below from NIH regarding the new features of the Human Subjects System. The system now has the ability to export Human Subject/Clinical Trial study records as an XML file so that it can be uploaded directly into Clinicaltrials.gov as part of the study registration. This new feature was implemented to help reduce administrative burden by not requiring manual entering of all data.
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Tuesday, February 26, 2019
Upgrades to be deployed to the Human Subjects System (HSS) on Wednesday, February 27, 2019 will include the ability to export Human Subjects/Clinical Trial (HSCT) study records in XML format. The exported file can then be uploaded into ClinicalTrials.gov as part of the study registration process.
This new feature aims to reduce administrative burden on applicants and grantees by decreasing the amount of information that must be manually keyed into ClinicalTrials.gov for study registration.
Here are some important points to remember about exporting the XML data:
·Use of the feature is optional.
·The export XML functionality is only available for clinical trial studies. This means only study records listed as clinical trials will have the Export XML button.
·To complete the export procedure, you will need to provide the following information:
oAn organization name. This is the one-word organization name assigned when you created the account in the Protocol Registration and Results System (PRS) at ClinicalTrials.gov.
oUnique Identification Protocol Number: Any unique identifier assigned to the Protocol by the Sponsor.
Once the XML file is exported from HSS, you will log into ClinicalTrials.gov to upload the study record. Please note the following for a successful upload:
·Each study record uploaded to ClinicalTrials.gov must have a unique title.
·Only XML records can be uploaded to ClinicalTrials.gov. The system will not accept PDFs, word documents, text documents, or spreadsheets.
·Since the Human Subjects/Clinical Trial (HSCT) form does not contain all the information required by ClinicalTrials.gov, you will need to edit the study record and provide the missing information to eliminate the errors.
Look for a new tutorial video demonstrating the process. It will be available at: https://era.nih.gov/era_training/era_videos.cfm#HSCT next week. In addition, look for detailed instructions and screenshots in the HSS online help.
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