Office of Research Administration

Clinical Trials – Usernames

How to Obtain a Clinical Trials Username


Downstate Medical Center – Applicable Clinical Trials process

An "Applicable Clinical Trial (ACT)," must be registered on the www.ClinicalTrials.gov website, when it meets the definition of an ACT according to the FDAAA 801 Requirements, or when required by other entities.  To determine if your clinical trial must be registered use the Clinical Trials ACT Checklist or check the requirements of other entities such as the  VA, CMS, WHO, PCORI, or ICMJE journals.

This Clinical Trials website provides more information on:

  • how to determine if your trial meets the definition of an ACT,
  • who is the responsible party,
  • how the responsible party registers the ACT,
  • the reporting requirements (e.g., administrative and scientific information, including AEs and research results), and
  • deadlines.

NOTE: Requirements may vary depending on the type of award and/or the sponsor.


Instructions for Obtaining a Clinical Trials username for Downstate Responsible Party

  1. The PI must have an RF account number associated with the study. If the study is funded by department funds, there should be an account number associated with these expenses.
  2. The PI/Study Coordinator must verify the protocol has been approved by the IRB, before it is registered.
  3. The PI/Study Coordinator should submit confirmation of an ACT via email to the Pre-Award office at  researchgrants@downstate.edu with a pre-filled copy of the Clinical Trials ACT Checklist , and the following information: IRB Approval #, Study Title, PI, Sponsor  and Funding source
  4. The PI will receive an email from clinicaltrials.gov, requesting the profile be updated. The PI must be the Responsible Party for the trial.


Helpful Tips/Things to Know:

  1. The responsible party (the sponsor or designated PI) for an Applicable Clinical Trial must submit the required clinical trial information no later than 21 days after enrollment of the first participant.  Failure of the responsible party to register an Applicable Clinical Trial or fulfill reporting requirements on the ClinicalTrials.gov website may result in heavy fines up to $10,000 per day for the institution and up to $250,000 per individual.
  2. When submitting a Multiple PD/PI (MPI) grant application to a federal sponsor, you may wish to identify the responsible party at the time of submission to avoid any delays in registering the study upon award.
  3. For any Clinical Trial Agreement which has been reviewed and negotiated by the Pre-Award office (on or after January 18th, 2017), the responsible party will be identified and named in the Agreement.
  4. For Oncology programs where the sponsor is an Oncology group funded through NCI, such as Alliance, NRG, etc – the responsible party is the sponsor, not the site PI.
  5. For any inbound subcontract, the responsible party is the prime awardee, not the site PI
  6. For procurement contracts (typically DOD, CDC and some NIH), the sponsor is typically the responsible party, although it is the PIs responsibility to confirm


Clinical Trials.gov, Helpful Links

Frequently Asked Questions: https://clinicaltrials.gov/ct2/manage-recs/faq#applicable
How to register a study: https://clinicaltrials.gov/ct2/manage-recs/how-register
How to edit a study record: https://clinicaltrials.gov/ct2/manage-recs/how-edit
How to submit results: https://clinicaltrials.gov/ct2/manage-recs/how-report


CONTACT US:

Sharon Levine-Sealy, Director of Pre-Award Operations
sharon.levine-sealy@downstate.edu
718-270-1303

Elliot Feder, Director, Post-Award Research Administration
elliot.feder@downstate.edu
718-270-3027

Kevin L. Nellis, MS, CIP, Executive Director
Human Research Protection & Quality Assurance
kevin.nellis@downstate.edu
718-270-8461

HELPFUL LINKS:

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

Clinical Trials and Human Subject Protection at the U.S. Food and Drug Administration.

NIH Clinical Research Trials and You – National Institutes of Health (NIH)