ClinicalTrials.gov

 

Contact Us

Contact the PRS administrator: Clinicaltrials.gov@einstein.yu.edu
718-430-2643 

Drop-in Office Hours

The PRS administrator will be available for assistance in Forchheimmer Library Training Room. Drop in with your ClinicalTrials.gov questions!

Tues. Oct. 23 1:00pm – 3:00pm
Tues. Nov. 6 1:00pm – 3:00pm
Tues. Nov. 20 1:00pm – 3:00pm
Tues. Dec. 4 1:00pm – 3:00pm
Tues. Dec. 18 1:00pm – 3:00pm
 

 

This website provides information to help investigators and research coordinators at Albert Einstein College of Medicine and Montefiore Medical Center understand the requirements and responsibilities for registering clinical trials and reporting results on ClinicalTrials.gov.

ClinicalTrials.gov is a public registry established by federal mandate as a means to provide public access to information on clinical trials for a wide range of diseases and conditions. Registration and, for certain studies, results reporting are required by regulatory and funding agencies including FDA, NIH, ICMJE, and CMS.

Data entry for ClinicalTrials.gov is done through the Protocol Registration and Results Reporting System (PRS) at register.clinicaltrials.gov . To obtain a PRS account, email ClinicalTrials.gov@einstein.yu.edu 

 

Which Trials Should be Registered on ClinicalTrials.gov?

In general, the following clinical trials must be registered on ClinicalTrials.gov:

  • Applicable Clinical Trials (ACTs) - clinical trials of FDA-regulated products (drugs, devices, or biologics), as long as the trial is neither a feasibility study of a device prototype nor a phase 1 study of a drug. (Phase 1 studies usually evaluate safety, maximally tolerated dose, pharmacokinetics, etc.). To determine if your study is an ACT, click here.
  • NIH-funded clinical trials – all clinical trials funded by NIH, wholly or in part, require registration and results reporting if the grant application was received by NIH on or after Jan. 18, 2017. Click here to determine if your study meets NIH's definition of a clinical trial.
  • Clinical trials being considered for publication in ICMJE-affiliated journals must be registered on ClinicalTrials.gov before the first participant is enrolled.For more information on the International Committee of Medical Journal Editors’ (ICMJE) publication requirements, click here.  
  • PCORI-funded patient registries and clinical studies must be registered on ClinicalTrials.gov. For more information on Patient-Centered Outcomes Research Institute (PCORI) requirements for registration, click here.
  • Your funding agency may have its own requirements; be sure to check the terms of your award letter.

Who is Responsible for Registering a Clinical Trial?

The Responsible Party is responsible for ensuring the trial is registered and for promptly making updates as required by all applicable regulations and policies. Provided certain stipulations have been met, Montefiore and Einstein designate the main Principal Investigator (PI) as the Responsible Party for the following clinical trials:

  1. Trials in which the PI holds the IND/IDE (the PI is also considered the sponsor-investigator).
  2. Trials initiated by the Principal Investigator.
  3. NIH-sponsored trials for which Montefiore or Einstein is the grantee institution.
  4. Trials, initiated by private industry or other outside entities, for which the Principal Investigator accepts the role of the Responsible Party in an explicit agreement.

When Must the Trial be Registered?

Montefiore and Einstein require registration on ClinicalTrials.gov of ACTs and NIH-funded trials prior to IRB approval. Elements of successful registrations include the following: 

  • The study record should not contain personal pronouns.
  • Acronyms and abbreviations are spelled out the first time they are used in the record.
  • The IRB# is listed as the Unique Protocol ID.
  • Outcome Measures are measurable quantities (i.e. nouns). The description contains the name and description of the metric/scale used to measure the outcome measure. The timeframe for the assessment of the measurement must be discrete and specific. 

For a list of items that must be addressed before releasing the record to PRS review, see the Protocol Registration Quality Control Review Criteria  

 

When are Updates Required?

Updates to the record are required throughout the life of the record. Specifically, updates must be made within 30 days of changes in the study status (e.g. changes in recruitment status, PI changes, study closures, etc.). If no changes are made to the record, the Record Verification field must be updated at least once every 6 months.

 

Results Summary Data

The Responsible Party is required to submit summary results data to ClinicalTrials.gov within 12 months of the primary completion date for ACTs, NIH-, and PCORI-funded studies. The results submission must include the following:

  • Participant Flow
  • Baseline Characteristics
  • Outcome Measures and Statistical analyses
  • Adverse Events

All results information must be aggregated, summary level data. Do not include data for the individual participants. No written results or conclusions are allowed in the free-text fields. For detailed information on how to submit summary results data, click here 

 

Uploading Documents

For trials with primary completion dates on or after January 18, 2017, the protocol and statistical analysis plan (SAP) must be uploaded to ClinicalTrials.gov. The protocol should be clear, concise, written in English and should clearly delineate the primary and secondary outcome measures. It must have a cover page with the official title, the NCT number and the protocol version date.

Clinical trials which receive IRB approval after January 21, 2019 and are supported by federal funding must upload an unsigned copy of one of the Informed Consent Forms (ICF) used in the study. The ICF must be uploaded after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol.

Personal identifiable information, trade secrets, and confidential information should be redacted from all documents prior to uploading, unless such information is required by the regulation. The documents should all be converted to PDF/A (A=archivable) format.

BEST PRACTICE: load all documents within 30 days after the last day of final data collection (i.e. within 30 days after the final study completion date). 

 

  FDA NIH ICMJE
Definition of Clinical Trial

FDA Clinical Trial Definition 

NIH Definition of Clinical Trial 

ICMJE Definition of Clinical Trial 

Why Trials must be Registered? 

FDA’s Applicable Clinical Trials (ACTs) Checklist 

NIH checklist 

use NIH checklist 

Type of Intervention

FDA-regulated drug, device, or biologic

Any Intervention

Any Intervention 

Study Phase

Any phase except phase 1 studies or device prototype feasibility studies

Any and all phases (including pilot, phase 1, and feasibility studies)

Any and all phases (including pilot, phase 1, and feasibility studies)

Deadline for Registering

Before IRB approval is granted (institutional policy)

Before IRB approval is granted (institutional policy)

Before first participant is enrolled (ICMJE’s policy)

Results data required?

YES

YES

Not required, but encouraged

Does System prompt for results data?

YES

NO

N/A

Funding Source

Any funding source or no funding source

NIH funding only

Any funding source or no funding source

Penalty for non-compliance

Monetary penalty up to $10,000/day for the duration of the violation

Monetary penalty including withholding of funds

Rejection of publication submission

Required Fields

Fields marked with * or *§ are required.

Secondary ID (in Study Identification module) - enter grant#
Collaborators (in Sponsor/Collaborators module) – enter funding center name

IPD Sharing Statement - Starting Jan. 2019, the "Plan to Share IPD" field must be answered in the original registration. The answer must be YES or NO (Select NO if undecided). Click here for more information

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