Clinical Trials Reporting

Check the ACT Checklist

Registration is required when the following regulations are met:

• The Food and Drug Administration (FDA) requires that all “applicable clinical trials” be registered to ClinicalTrials.gov within 21 days of the first subject’s enrollment.
  • The FDAAA Decision Tree helps determine whether a study is an “applicable clinical trial”:  http://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm
• The International Committee of Medical Journal Editors’ (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals is contingent on ClinicalTrials.gov registration prior to the first subject’s enrollment.
• Any NIH-funded clinical trial requires registration and results reporting per FDA applicable clinical trials definition
• Results reporting is required by the FDA for all “applicable clinical trials.” The ICMJE does not currently require results reporting.

Of course! Please send your study’s protocol, consent, and UWCCC number to ct.gov_help@clinicaltrials.wisc.edu

The CT.gov record should be published within 21 days of enrolling the first subject (FDA requirement) or before enrolling the first subject (ICMJE requirement).

Email ct.gov_help@clinicaltrials.wisc.edu with:

1. The protocol’s UWCCC ID
2. The anticipated Open to Accrual Date
3. The name of the person who will be reviewing the CT.gov record (PI, program manager, etc.)
4. All available study documents, if they are not available in OnCore
5. Confirmation that all OnCore data fields that are marked as “Completion Required by IRB Initial Approval” in the DFDs are complete and accurate

Registration may take up to 3 weeks; please contact ct.gov_help@clinicaltrials.wisc.edu as early as possible

The National Clinical Trial (NCT) number is the unique identifier assigned by CT.gov. To receive an NCT number, the study must be successfully registered with CT.gov. This takes a minimum of 2 days after submitting the record to CT.gov for review, and may take longer if CT.gov staff have any questions or comments.

1. Log in at: https://register.clinicaltrials.gov/
2. Contact ct.gov_help@clinicaltrials.wisc.edu for your username, password, to create a CT.gov account, or for any other help accessing CT.gov.

Let ct.gov_help@clinicaltrials.wisc.edu know the date the last participant is expected to be seen for their last follow up. CT.gov results are due 12 months from the date the last data point is collected to answer the primary outcome measure.

1. Log into CT.gov at https://register.clinicaltrials.gov/
2. Search for your protocol
3. Click “Open” in the left-most column
4. In the protocol, click “Open” to the left of the Protocol Section
5. Click “Edit” to the left of each of the following modules and review all the information. If there are any errors, correct them and click “Save.” If there are no errors, click “Cancel.”
   1. Study Identification
   2. Study Status
   3. Sponsor/Collaborator
   4. Oversight
   5. Study Description
   6. Conditions
   7. Study Design
   8. Arms and Interventions – click “Open”
      1. Click “Edit” for Arms
      2. Click “Edit” for Interventions
   9. Outcome Measures
   10. Eligibility
   11. Contacts/Locations – click “Open”
       1. Click “Edit” for Overall Contacts
       2. Click “Edit” for Locations
6. Once each section has been reviewed, click “Record Summary” at the top of the page
7. Click the green “Entry Complete” button at the top of the page. This will send a notification to the CT.gov admin that the record is complete and accurate, and the CT.gov admin will release the study for PRS review.

To start:

1. Log into CT.gov at https://register.clinicaltrials.gov/
2. Search for your protocol
   1. Click “Open” in the left-most column
3. In the protocol, click “Open” to the left of the Results Section
4. Detailed information is not available on the splash page – each section should be reviewed individually. Open each of the following modules to validate the information:

Note that each “Edit” page has “Help” and “Definitions” links at the top of the page with section-specific information. Data fields have strict definitions; please review “Help” or “Definitions” if you have questions about specific data fields. Please contact ct.gov_help@clinicaltrials.wisc.edu for any additional assistance.

Participant Flow

1. To make any changes, click “Edit”
2. The most common edit is to correct the “Reason Not Completed” section. The dropdown menu provides the most common reasons, as well as a blank “Other” option.
3. If changes were made, click “Save.” If not, click “Cancel”
4. To move on to the next section, click “Results Section” at the top of the page

Baseline Characteristics

1. Age, Sex, Race, and Region of Enrollment are required. Any additional measure types are added by the ClinicalTrials.gov Specialist based on the provided publication/manuscript. If these additional measure types are not relevant, click “Delete” to the left of the section.
2. To make any changes, click “Edit” to the left of the section
3. If there should be a change in the number of rows, click either “Delete” or “Add Row” in the left-most column
4. If changes were made, click “Save.” If not, click “Cancel.”
5. To move on to the next section, click “Results Section” at the top of the page

Outcome Measures

1. Review each outcome measure by clicking “Edit” on the left
2. Note: Analysis Population Description should NOT contain any written results information. This section is best used in cases where the number of participants analyzed differs from the number of participants assigned to the arm to provide rationale for the difference.
3. Pay particular attention to the Outcome Measure Data Table
   1. The Unit of Measure should be as specific as possible. The majority of CT.gov deferrals are due to incorrect units of measure. If a ‘commonly reported unit’ (i.e., units on a scale, percentage of <something>) is used, please ensure that this is as specific as possible, with detailed information about the scale (i.e., ECOG) in the Outcome Measure Description section.
4. If there should be a change in the number of rows, click either “Delete” or “Add Row” in the left-most column
5. Note: Some Outcome Measures may require Statistical Analyses. Please contact ct.gov_help@clinicaltrials.wisc.edu if you think this is the case for your protocol
6. If changes were made, click “Save.” If not, click “Cancel.”
7. To move on to the next section, click “Results Section” at the top of the page

Adverse Events

1. The ClinicalTrials.gov Specialist enters all Adverse Events and SAEs available in OnCore. Before deleting any AE or SAE information, review the CT.gov definition of AE:

2. Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research.

3. Review the top table by clicking “Edit.” This section includes information about the Source Vocabulary (i.e., CTCAE 4.0)
4. All-Cause Mortality is a table of all anticipated and unanticipated deaths due to any cause
5. Serious Adverse Events is a table of all anticipated and unanticipated serious adverse events
6. Adverse Events is a table of all anticipated and unanticipated serious adverse events

Limitations & Caveats

This is best used if the study was terminated early. Do NOT include written results information. All results information should be entered in the AE or Outcome Measure tabs.

More Information

Update any contact information.

Once each section is complete:

1. Contact ct.gov_help@clinicaltrials.wisc.edu with any questions
2. Once each section has been reviewed, click “Record Summary” at the top of the page
3. Click the green “Entry Complete” button at the top of the page. This will send a notification to the CT.gov admin that the record is complete and accurate, and the CT.gov admin will release the study for PRS review.