ClinicalTrials.gov Support

Comprehensive assistance that ensures your clinical trials meet public and regulatory standards on time

What is this offering?

This service supports the registration of studies on the ClinicalTrials.gov website (prioritizing NIH-defined clinical trials). ClinicalTrials.gov is a web-based resource that provides patients, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies covering a wide range of diseases and conditions.

Our support includes:

• Identification of registration and results reporting requirements and related deadlines.
• Evaluation of the research protocol to facilitate efficient registration.
• Assistance with establishing Protocol Registration and Results System (PRS) accounts.
• Assistance with PRS login, navigation, and data entry activities.
• Ensure informed consent document includes information required by ClinicalTrials.gov.
• Entry of registration data into the PRS database.
• Management of PRS queries that may occur during the registration and maintenance process.
• Guidance regarding regulations and processes associated with annual and unscheduled updates.
• Email reminders (for all projects registered by the MICHR ClinicalTrials.gov team) designed to ensure applicable ClinicalTrials.gov deadlines are met
• Coordinated consultations with partner offices and others relevant to registration.

For more information about clinicaltrials.gov registration, upkeep, and results reporting, please visit the ClinicalTrials.gov Registration and Activity Map located on the Office of Regulatory Affairs’s website.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research