Clinical Trials Registration

REGISTER NOW

Tuesday, April 24, 2018
Presentation:  12-1pm
Q&A from 1:00 - 1:15pm

FREE Registration

US researchers have been required to register with ClinicalTrials.gov and report results for over a decade and in 2016 regulators issued clarification on applicability of the requirement.  But, as recent news reports and analyzes have shown, compliance is sill inconsistent.  Investigators and study teams need to be aware of the requirements of several governing bodies (such as the FDA, NIH, ICMJE, WHO, CMS and more) in order to ensure that studies are being accurately registered and reported.

In this webinar, Anthony Keyes, Program Manager @ the Johns Hopkins University School of Medicine ClinicalTrials.gov Program, reviews the federal regulations regarding registration and results reporting of clinical trials.  He will also provide suggestions to help researchers comply with this requirement.

Presentation Objectives

Describe the background and applicable regulations regarding clinical trial registration and results reporting
Explain he "who, what, where, when, why and how" of study registration and results reporting 
Outline tips and tricks for accurate and timely record creation and maintenance

Who Should Attend?

PI's and study team members who are currently conducting or planning to conduct any clinical, interventional or behavioral research
This includes investigator-initiated studies and studies funded in part or in whole by NIH, CHS or foundations now requiring registration and/or results reporting

Certificates of attendance are available for this event.
Space is limited - REGISTER NOW! (link: http://www2.sairb.com/clinical-trials-registration-reporting)

If you have any questions, please do not hesitate to contact me.  (mazarp@georgetown.edu or 412-760-5297)

 

Updates from ClinicalTrials.gov

New PRS Test System

Results Expected Dates

All Results Expected date was added to indicate the latest date by which results information must be submitted for all Primary and Secondary Outcome Measures. The Results Expected date is now calculated as 1 year after the Primary Completion Date and the All Results Expected date is calculated as 1 year after the Study Completion Date

A new problem type has been added to the home page Record List and Custom Filter: Incomplete Results - per FDAAA. This problem is issued when the All Results Expected date has passed and results information has not been posted to ClinicalTrials.gov for all Primary and Secondary Outcome Measures. The Late Results - per FDAAA problem type is issued when results information has not been posted to ClinicalTrials.gov for all Primary Outcome Measures. Note that results information, including each primary and secondary outcome measure, must generally be submitted within 1 yearof the Primary Completion Date for applicable clinical trials required to be registered (as described in 42 CFR 11.42 and 11.44).

Two Results validation warnings messages were added. A validation warning appears when a Primary Outcome Measure has an Anticipated Reporting Date later than the Results Expected Date or a Secondary Outcome Measure has an Anticipated Reporting Date later than the All Results Expected date. Also, when the current date is after the Results Expected or All Results Expected date, a validation warning appears on each Primary or Secondary Outcome Measure in the Results Section that does not include an Outcome Measure Data Table.

Study Document Submission

The "Help" page in the Document Section has been improved to provide more detailed instructions for preparing and uploading study documents (Study Protocol, Statistical Analysis Plan and, optionally, Informed Consent Form), as part of Results submission for studies with a Primary Completion Date on or after January 18, 2017.

Study Documents may no longer be submitted before a human subjects protection review board has approved the study, except when such approval is not required.

Resources

Final Rule Webinar

Results Reporting 

New England Journal of Medicine – Trial Reporting in ClinicalTrials.gov – The Final Rule

Related Journal Publications