NIH Clinical Trials

Syracuse University supports researchers in conducting NIH-funded clinical trials by providing guidance on registration, compliance, and results reporting. All NIH-funded trials must be registered and submitted to ClinicalTrials.gov, and ORIP assists investigators with account setup, data entry, and adherence to federal policies. Following these processes ensures ethical conduct, regulatory compliance, and transparency in clinical research.

NIH Clinical Trials Registration at Syracuse University

Syracuse University is committed to ensuring compliance with NIH policies regarding clinical trials. Effective January 18, 2017, all NIH-funded clinical trials are required to register and submit results information to ClinicalTrials.gov.

Determining If Your Study Qualifies as a Clinical Trial

A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health-related biomedical or behavioral outcomes. To determine if your study qualifies, refer to the NIH Decision Tree and additional resources provided by NIH.

Registration Process

1. Request a ClinicalTrials.gov Account: Email the Office of Research Integrity and Protections (ORIP) at orip@syr.edu with "ClinicalTrials.gov Protocol Registration" in the subject line. Include your name, telephone number, and email address.
2. Account Setup: You will receive a login name and a temporary password from ClinicalTrials.gov.
3. Access the Protocol Registration and Results System (PRS): Log in using your credentials. The Organization name is SyracuseU.
4. Change Password: Immediately update your temporary password to a unique one.

Submitting a Study

1. Preparation: Gather necessary information, including study design, eligibility criteria, and outcome measures.
2. Login to PRS: Access the system and begin entering study details.
3. Data Entry: Complete all required fields. Refer to the Protocol Registration Data Element Definitions for guidance.
4. Review: Preview your submission to ensure accuracy.
5. Submission: Click "Entry Complete" to submit your registration.

Post-Submission

• Results Reporting: Submit results information to ClinicalTrials.gov within 12 months of the study completion date.
• Compliance: Adhere to NIH policies and federal regulations regarding clinical trial registration and reporting.

Training and Support

• CITI Training: Complete the Collaborative Institutional Training Initiative (CITI) program, which includes modules on Good Clinical Practice (GCP) and human subjects research.
• ORIP Assistance: For guidance on the registration process, contact ORIP at orip@syr.edu or 315-443-3013.

By following these steps, researchers can ensure compliance with NIH policies and contribute to the transparency and accountability of clinical research.