To register your trial on ClinicalTrials.gov, you must have a username and password. Please submit requests for this information to firstname.lastname@example.org. Please give your full name with title, phone number, and email address. The administrator will issue a username and password which will be emailed to you by ClinicalTrials.gov.
Once you have received your username and password, go to http://register.clinicaltrials.gov to register your trial. The Organization name on the login page is WashingtonU. A list of all the elements that are required by the law can be found on the ClinicalTrials.gov Protocol Registration System Information Website at http://prsinfo.clinicaltrials.gov/definitions.html. A list of responses to common fields at Washington University can be found at the end of this document.
When completing your registration, please use the HRPO number as the “Study ID number.” This will make it easier for the Washington University administrators to identify, track, and assist you with questions or requests. If you are registering a new study, choose a Study ID number that will be familiar to you. You can modify your registration after you receive your HRPO number.
After completing your registration, please make sure to look it over and make edits in regard to any Warning, Error, or Alert messages that are automatically generated before submitting it for approval and release.
Once you have finished your submission, you must select “Complete” at the top of the protocol record. The Washington University administrators will then receive an email. The submission will be reviewed to make sure all warnings, errors, and alerts are addressed and all applicable notes are addressed. If so, it will be approved and released. If not, the administrator will send you an email asking for edits.
After it is released, ClinicalTrials.gov will issue a ClinicalTrials.gov Identifier within 2 to 5 days. To obtain this ID#, go to clinicaltrials.gov and search for your study. The identifier is found on the record.
Protocol records for active trials are required to be reviewed and modified as needed at least every 6 months. Pay special attention to recruiting status and contact information as the accuracy and timeliness of this information is extremely important. Remember to update the Record Verification Date field in the registration.
ClinicalTrials.gov Guide to Common Fields
Unique Protocol ID: Can be any number you will associate with the trial. It is recommended that you use the HRPO number.
Board Name: Washington University Human Research Protection Office
Board Affiliation: Washington University in St. Louis
Board Contact: Business Phone: 314-747-6800
Business Email: email@example.com
Business Address: 660 South Euclid Avenue, Campus Box 8089, St. Louis, Mo 63110
Oversight Authorities: United States Institutional Review Board
Who is responsible for registering the trial? (designated the “responsible party” in the law)
The sponsor of the clinical trial; – OR – The principal investigator (PI) of such clinical trial if so designated by a sponsor, contractor, grantee, or awardee, so long as the PI is responsible for conducting the trial and has sufficient data rights.
For NIH-funded clinical trials where there is an IND holder, consistent with FDA regulations, the IND holder is the sponsor, and will be considered the responsible party unless this obligation is delegated to the principal investigator. For NIH-funded clinical trials where there is no IND holder, the funding recipient will be considered the responsible party.