SUNY Downstate Health Sciences University
Office of Research Administration
How to Obtain a Clinical Trials Username
Downstate Medical Center – Applicable Clinical Trials process
An "Applicable Clinical Trial (ACT)," must be registered on the 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
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
- 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.
- The PI/Study Coordinator must verify the protocol has been approved by the IRB, before it is registered.
- The PI/Study Coordinator should submit confirmation of an ACT via email to Sponsored Programs Administration at firstname.lastname@example.org with a pre-filled copy of the Clinical Trials ACT Checklist , and the following information: IRB Approval #, Study Title, PI, Sponsor and Funding source
- 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:
- The term ‘Responsible Party’ applies to the person/organization responsible for reporting an Applicable Clinical Trial in clinicaltrials.gov. Examples of a ‘Responsible Party’ are below:
- The holder of an Investigational New Device (IND) or Investigational Device Exemption (IDE)
- A pharmaceutical company (sponsor) when funding a study
- The PI when a study is investigator-initiated, regardless of sponsor
- The PI/prime awardee of a grant (i.e. inbound subcontract, NOA)
- The sponsor for procurement contracts (typically DOD, CDC and some NIH); although it is the PIs responsibility to confirm
- The sponsor where it is an Oncology group funded through NCI (i.e. Alliance, NRG, GOG, etc.)
- The ‘Responsible Party’ must register and submit the required clinical trial information no later than 21 days after enrollment of the first participant. Failure 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.
- When submitting a Multiple PD/PI (MPI) grant application to a federal sponsor, you should identify the ‘Responsible Party’ at the time of submission to avoid any delays in registering the study upon award.
- For all Clinical Trial Agreements reviewed and negotiated by Sponsored Programs Administration, the ‘Responsible Party’will be identified and named in the Agreement.