The US Food and Drug Administration (FDA), the International Committee of Medical Journal Editors (ICMJE), and the World Health Organization (WHO) are just a few of the groups calling for clinical trials registration..


Registration Requirements:

Food and Drug Administration Amendments Act of 2007 (FDAAA)


Mandates registration of ‘Applicable Trials’:

·         Phase 2 – 4 Interventional studies.

·         Studies involving drugs, biologics, or medical devices regulated by FDA.

·         Studies that have at least one site in the US or is conducted under an IND or IDE.

·         Studies initiated or ongoing as of September 27, 2007 or later.


Basic Results Posting:

·         Basic results posting is required for trials of FDA-approved drugs and devices.

·         Submission of results is required within 12 months after primary endpoint completion date.


Adverse Event Posting:

·         Adverse event posting is required for trials of FDA-approved drugs and devices.

·         serious adverse events.

·         other (non-serious) adverse events that exceed a frequency threshold of 5 percent in any arm of the clinical trial.

§         (Trials of Drugs and Biologics (controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation) and Trials of Devices (Controlled trials with heath outcomes of devices subject to FDA regulation, other than small feasibility studies), and pediatric post-market surveillance of devices must be registered on


Who is responsible for registration and results reporting?

·         Either the sponsor or the principal investigator of a clinical trial is responsible for submission of clinical trial information into the Clinical Trial Registry Data Bank.

·         No later than one year after completion (actual or estimated) of the trial.


International Committee of Medical Journal Editors (ICMJE):

·         Trials must register at or before the onset of patient enrollment.

·         ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.


When do I register my study?

FDA: No later than 21 days after enrolling the first subject.

ICMJE: Before recruitment of the first subject.


How Parallax can help:

Parallax Clinical Research, LLC is a consulting firm devoted to advancing the development of early stage pharmaceutical and biological products. At Parallax Clinical Research, we have put together an outstanding group of skilled professionals with many years of experience in the pharma industry to assist in the drug development process. We have worked hand in hand with major pharmaceutical companies and small business alike.

Parallax Clinical Research’s staff of experienced scientists and clinicians have expertise in posting studies and results on

·         We can post protocols and results based on protocols and clinical study reports.

·         Basic results reporting.

·         Adverse event reporting.

·         Speedy turnaround.

·         Every study is reviewed by a different individual to guarantee quality assurance.


To find out more information, please contact us