What is this service?
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 service 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
Who can use this service?
This service is available for study teams working on investigator-initiated clinical trials that are 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 should I contact MICHR about this service?
If you are working with a Clinical Trial Support Unit, they should connect your study team to this service. However, feel free to contact us directly for additional information: MICHR-CT.firstname.lastname@example.org
How much does this service cost?
There is no fee for this service. The cost pricing/recharge rates for this and other MICHR services are available here.