Knowledge Base

What specific information must be provided to ClinicalTrials.gov?

27 December 2023
2 min read

Federal regulations require that applicable clinical trials and NIH-funded clinical trials be registered no later than 21 days after enrollment of the first participant. However, researchers should be aware that ICMJE requires registration prior to enrollment of any subjects, and member journals may decline publication articles from studies that were not registered in accordance with this requirement.After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, one IRB-approved informed consent form used to enroll subjects must be posted to Cliniclatrials.gov.

Results from clinical trials must be reported to ClinicalTrials.gov no later than 12 months after the primary completion date. The primary completion date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.

For clinical trials initiated on or after January 18, 2017, information submitted to ClinicalTrials.gov must be updated at least once every 12 months.

Deciphering Telomerase Inhibitors and Keeping Up with Their Recent Developments
Deciphering Telomerase Inhibitors and Keeping Up with Their Recent Developments
27 December 2023
Telomerase inhibitors are drugs that target the enzyme telomerase, crucial in maintaining DNA integrity and stability.
Read →
What factors should be considered when placing physical distances in the workplace in the event of an infectious disease?
Knowledge Base
2 min read
What factors should be considered when placing physical distances in the workplace in the event of an infectious disease?
27 December 2023
When placing physical distances in the workplace in the event of an infectious disease, it is important to consider several factors.
Read →
Cullinan Oncology begins Phase 1 trial of CLN-617, a novel biologic fusing IL-2 and IL-12 cytokines
Latest Hotspot
3 min read
Cullinan Oncology begins Phase 1 trial of CLN-617, a novel biologic fusing IL-2 and IL-12 cytokines
27 December 2023
Cullinan Oncology has initiated a Phase 1 study of CLN-617, an innovative biologic that combines the properties of IL-2 and IL-12 cytokines
Read →
An analysis of Anlotinib Dihydrochloride's R&D progress and its clinical results presented at the 2023 ESMO_ASIA Annual Meeting
ESMO 2023
4 min read
An analysis of Anlotinib Dihydrochloride's R&D progress and its clinical results presented at the 2023 ESMO_ASIA Annual Meeting
27 December 2023
the latest clinical results of Anlotinib Dihydrochloride were presented in 2023 ESMO_ASIA.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.