ClinicalTrails.gov Registration

• Enter the study registration information and ensure that MCW-Sponsored clinical trial registration in ClinicalTrials.gov meets the requirements of applicable laws and regulations.
• Assignment of a NCT number does not ensure compliance.
• The study record must be maintained for accuracy and updated throughout the life-cycle of the research study by the Principal party.
• Study results must be entered, with few exceptions, no later than 12 months after the Primary Completion Date

• Provide MCW user accounts and temporary passwords through PRS
• Reset passwords
• Notify the study team of Records which require modification due to errors, late results, not being updated etc.
• Change record ownership
• Facilitate transfer of study records from previous institutions
• MCW is NOT responsible for submitting an application or ensuring the accuracy of the content posted on ClinicalTrials.gov

Visit ClinicalTrials.gov How to Register Your Study for a step-by-step explanation of the registration process.

Data Elements Definitions provides a detailed explanation of the data fields within ClinicalTrials.gov. It is highly recommended you use the unique IRB number as the Unique Protocol ID in the PRS data element.

When registering a study, it will have to be decided who is the Responsible Party and the Record Owner. They may be one in the same. By definition:

Responsible Party:  An entity or individual who is responsible for registering a clinical investigation and submitting clinical trial information

• Can be the Sponsor for the trial
• Can be the PI if they conduct the trial, control the data and have the rights to publish

Record Owner:  The primary contact for the record. Anyone can be the owner of a study. Owners are often Study Coordinators or other study team members and assist the Responsible Party (RP) with data entry. They can be assigned to create the study record, grant other users access and receive e-mail communications along with the RP.

The Responsible Party must update and correct clinical trial information on ClinicalTrials.gov:

• Corrections are required if potential issues are identified as part of the ClinicalTrials.gov quality control review or if the responsible party becomes aware of errors
• It is recommended that the Record Verification Date be updated at least every 6 months for studies not yet completed, even if there were no changes to the record
• Generally required to update information at least once every 12 months such as anticipated study end date, protocol amendments, etc.
• Some data elements must be updated more rapidly
  • FDAAA – Update within 30 days of any changes to Overall Recruitment Status or Primary Completion Date

• Standard results submission deadline
  • Applies to applicable clinical trials required to have results information submitted (under 42 CFR 11.42)
  • Results information must be submitted no later than 1 year after the Primary Completion Date
• Exceptions: Delayed submission
  • Seeking approval, licensure, or clearance of a new use
  • Seeking initial approval, licensure, or clearance
  • Extensions for good cause

Example Studies for Results Data Entry on ClinicalTrials.gov (found at the bottom of the page)

The final revisions to the Common Rule related to posting the Informed Consent were effective January 21, 2019.

1. For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Website that will be established as a repository for such informed consent forms.
2. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal website (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
3. The informed consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

More Info

• Acceptable Federal websites include ClinicalTrials.gov and Regulations.gov
• The Consent form must have been used to enroll patients
• There is no requirement to post consent forms prior to January 21, 2019
• Consent forms may be uploaded in the PRS Document Section