Assistance Available to Help with Results Reporting to ClinicalTrials.gov

Points of Contact

These individual will be working with the Clinical Directors to assist investigators with Research Results Reporting for Clinical Trials.gov:

• Points of Contact FDAAA

Assistance Available Through BTRIS

Help can be found at BTRISSupport@nih.gov or by calling 301-827-8270 or by reviewing the Biomedical Translational Research Information System (BTRIS)/ClinicalTrials.gov User Guide

The benefits to the user of using BTRIS to submit data to ClinicalTrials.gov include:

• Reusing data already existing in BTRIS e.g. demographics
• Aggregating data in the ClinicalTrials.gov defined format from the raw data the user provides
• A simple, easy to fill spreadsheet that provides data for results
• Providing a mapping tool for standardizing (MedDRA) adverse events
• BTRIS experience submitting results for NHLBI, NIAAA, NIAID and NICHD, NIMH studies
• Providing a much simpler web based user interface focusing on required fields
• Having the ability to submit only certain sections or all sections of ClinicalTrials.gov
• Having an interface to directly submit results to ClinicalTrials.gov
• Providing expertise in ClinicalTrials.gov rules/workflows for submission
• BTRIS closely works with NLM and Institute QA contacts for data submission
• Integration with institute data systems, for reusing data for results

For individual help or information, please contact:

• Beri, Andrea (NIH/CC)
• Rath, Sachi (NIH/CC)

Assistance Provided by NLM

ClinicalTrials.gov is piloting a process to provide one-on-one assistance to investigators throughout the results submission process. As part of the process, a member of the ClinicalTrials.gov results team would be assigned to help prepare you for results submission, orient you to the PRS (protocol registration and results system), and walk you through the data entry process. If you would like to take advantage of this assistance, please send a request to register@clinicaltrials.gov that includes some available dates/times (including time zone) for an introductory call and the best phone number to reach you.