Orthopaedic Research Administration

Yes, you can! ClinicalTrials.gov will allow registration of the study prior to getting CHR approval if the Overall Recruitment Status of the study is “Not yet recruiting.” CHR approval must be obtained before the study’s Overall Recruitment Status is changed to “Recruiting”. When CHR approval is obtained, update the protocol registration and release the study to ClinicalTrials.gov for review and processing.

Yes, you can register a study on ClinicalTrials.gov at any time. However, FDAAA Section 801 requires applicable clinical trials to be registered within 21 days of enrollment of the first participant. ICMJE journals (and other journals) require registration of all clinical trials before enrollment of the first participant.

Yes, this has all been vetted with the budget office. Please contact the Department's Clinical Research Coordinator, Rachelle Palkovsky [email protected]; Ph: (415) 476-8362 for additional information.

Results submission for non-applicable clinical trials is not required (for example, a behavioral study).

If no participants were ever enrolled in the trial, no results must be reported. Remember to change the Overall Recruitment Status to “Withdrawn.”

For a trial that terminated early after participants were enrolled, provide any available data for Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Events. If no data are available for any of the Outcome Measures, specify zero (“0”) for the Number of Participants Analyzed in each Arm/Group, and leave the data fields blank. Provide an explanation in the Analysis Population Description for why zero participants were analyzed and, if appropriate, provide information in the Limitations and Caveats module. You must still provide data for Participant Flow, Baseline Characteristics, and Adverse Events

The data must be reported on ClinicalTrials.gov as soon as possible. The International Committee of Medical Journal Editors has indicated that they do not consider publishing to ClinicalTrials.gov as “pre-publication.” Refer to their FAQs for useful information. 

Because data reviews are retrospective and largely observational in nature and, in general, exempt research studies are not controlled clinical trials, nor involving an FDA-regulated intervention, they would not need to be registered or reported on ClinicalTrials.gov.

However, the ICJME may have a different opinion if exempt research involves any of the following:

• drugs;
• surgical procedures;
• devices;
• behavioral treatments;
• dietary interventions;
• process-of-care change;
• biomedical or health-related measures including pharmacokinetic measures and adverse events.

If the applicable clinical trial has reached the primary completion date, then results must be submitted by the Responsible Party no later than 12 months after the primary completion date. If the ACT is investigating mortality over a long period of time (e.g., 10 years) and the investigator chooses to analyze mortality trends over time during the course of the study, the outcome measures may be revised in the PRS according to the desired analysis timeframe while the study is still ongoing. If, in this example, the only primary outcome measure is mortality at 10 years and the investigator does not choose to analyze the data prior to the primary completion date, the study will still be considered ongoing. The record, however, should be updated regularly to accommodate for enrollment status and protocol/amendment verification.

The primary outcome measure should have an estimated time frame.

Yes, but you may ‘delay results posting’ until 30 days after the product receives FDA approval or clearance. You do not qualify for this delay if you are using approved products ‘off-label’. Only investigational products (i.e., no FDA approvals/clearance for any indication) qualify for delayed results posting. However, the NIH encourages results reporting for all NIH supported clinical trials registered in ClinicalTrials.gov, regardless of whether or not they are required to do so under FDAAA.

FDAAA requires the reporting of results for all primary and secondary outcome measures/endpoints for applicable clinical trials. Tertiary and exploratory outcomes are not captured as part of FDAAA.

Though there is no official guidance, ClinicalTrials.gov generally advises completing data entry ASAP but not later than 12 months after data collection has ended for that measure. If data collection ongoing, it is a good idea to provide the anticipated posting date for that measure so it is clear to the public when the information will be made available.

In a case like this, the study team may submit an extension request, indicating that the study has not been unblinded and reporting the primary outcome measure data would interfere with the scientific integrity of the study. For assistance with this request, contact [email protected].

For studies that do not involve a drug or biologic, such as behavioral interventional studies or device trials, select ‘Not Applicable’.

FDAAA does not require that patient-level data/raw data be entered into ClinicalTrials.gov. Summary data, similar to that represented in manuscripts, is entered into ClinicalTrials.gov

The ClinicalTrials.gov protocol registration/results reporting system interface was originally developed prior to 2000 when ‘results reporting’ was not a requirement. Since the implementation of the ICMJE requirements and FDAAA enactment, this system has been adapted in many ways to meet challenging data requirements. Continuous enhancement occurs as various users make suggestions to the ClinicalTrials.gov staff. It is likely, however, that the tool will continue to maintain a form/function similar to the current tool.

If the trial is still collecting follow-up data, but the primary outcome measure was completed before 2007, do results still need to be entered?

Trials that were “ongoing” as of December 26, 2007 (i.e., participants were being recruited, were being selected from a predetermined population, or were being treated or examined) require results reporting within one year of the Primary Completion Date. The Primary Completion Date is defined as the date the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.