ClinicalTrials.gov Support

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

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Who?

Any U-M researcher and their research partners working on investigator-initiated clinical trials supported by any Clinical Trial Support Unit (CTSU) other than the Oncology CTSU. (For support of Oncology clinical trials, please contact the Oncology CTSU directly.)

When?

The CTSU will connect study teams to this offering.

How much?

Free

What is this offering?

This service supports the registration of clinical trials on the ClinicalTrials.gov website. 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
  • Entry of registration data into the PRS database
  • Management of PRS queries that may occur during the registration process
  • Guidance regarding regulations and processes associated with annual and unscheduled updates
  • Email reminders designed to ensure applicable ClinicalTrials.gov deadlines are met
  • Coordinated consultations with the Office of Regulatory Affairs as needed

How this advances translational science

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

Translational Science Categories: