FDA and NIH Launch Three-Part ClinicalTrials.gov Compliance Training for Sponsor-Investigators in July 2026

Regulatory affairs leads at pharma manufacturers acting as sponsor-investigators face renewed scrutiny on ClinicalTrials.gov registration and results reporting obligations, and a three-session virtual training hosted by CDER SBIA in July 2026 addresses the compliance gaps most likely to draw enforcement attention. The sessions run July 14, 22, and 30, each from 1:00–2:00 p.m. ET.

The program is structured as a hybrid format: participants must complete a required on-demand video before registering for any live panel. Questions can be submitted in advance to ClinicalTrials.govAMCTraining@fda.hhs.gov or during the registration process, with the expert panel using submitted questions to shape each session's discussion. The format is designed to move beyond procedural overview and into practical resolution of reporting errors.

Coverage spans the full compliance surface for trial sponsors. Topics include critical registration and results-reporting deadlines under federal requirements, common submission errors and corrective actions, and functionality within the Protocol Registration and Results System (PRS). Separate guidance will be provided by representatives from CDER, CBER, and CDRH, reflecting the distinct regulatory nuances across drug, biologic, and device product types.

Presenters include Dr. Laurie Muldowney, Deputy Director of the Office of Scientific Investigations within CDER's Office of Compliance, who will cover registration and reporting requirements and serve as panel moderator. Jennifer Vuong, Pharm.D., from the Compliance Enforcement Branch, will address legal obligations directly. Anna M. Fine, Pharm.D., M.S., Director at the National Library of Medicine, will cover where and how trials are submitted for public posting. The seniority of the presenter roster signals that the training carries weight beyond routine outreach.

Although the stated audience is academic medical centers, the compliance obligations covered apply equally to pharma manufacturers holding IND sponsorship. Reporting failures on ClinicalTrials.gov carry civil monetary penalty exposure under 42 CFR Part 11, and enforcement activity in this area has increased alongside the FDA's broader transparency agenda. QA and regulatory teams supporting sponsor-investigator trials should treat the pitfalls session, in particular, as a gap-assessment opportunity against current internal SOPs.

Completion of the pre-recorded module and attendance across all three live panels positions regulatory teams to benchmark their ClinicalTrials.gov workflows against current FDA and NIH expectations ahead of any inspection cycle that touches clinical data transparency.

Source: FDA CDER SBIA via FDA.gov What's New: Drugs RSS Feed, June 10, 2026. Live sessions: July 14, 22, and 30, 2026, 1:00–2:00 p.m. ET.