This page provides step-by-step instructions on using clinicalTrials.gov for publishing details of clinical trials. 

It gives: 

  • An overview of the system
  • Explains how the system is administered
  • Advises on procedures

ClinicalTrials.gov

Overview

This page provides step-by-step instructions on using ClinicalTrials.gov for publishing details of clinical trials. 

It gives: 

  • An overview of the system
  • Explains how the system is administered
  • Advises on procedures

Overview:

ClinicalTrials.gov is a publicly accessible database which is free to register details of your clinical trials. 

The database has a web-based registration system, accessible at ClinicalTrials.gov which allows you to submit trial information online. 

The Joint Research Compliance Office is the designated 'Administrator' for registering users on ClinicalTrials.gov.

As Administrator, we will create a user account for you (upon request), giving you access to register trials on the system and helping with enquires. We will check and release records for National Library of Medicine review once you have completed them properly. 

We also serve as the contact point for the ClinicalTrials.gov team and will resolve any questions associated with trial information.

Please note: 

  • You can register on ClinicalTrials.gov whether your main employment contract is with Imperial College or Imperial NHS Trust

JRCO

The Research Governance Administrator is the College's designated 'Administrator' for registering trials on clinicalTrials.gov. 

The Research Governance Administrator will create a user account for you (upon request) giving you access to register trials on the system, they will also release records for public view once you have completed them. 

The Research Governance Administrator will also serve as the contact point for the ClinicalTrials.gov team and will assist with queries associated with trial information. 

Please note: 

  • You can register on ClinicalTrials.gov whether your main employment contract is with Imperial College or Imperial NHS Trust

Investigators

Once your user account is created, you will be able to enter information about your clinical trial online. 

The World Health Organisation (WHO) registration advisory group identified a minimal registration data set further information please see JRCO/SOP/022.

Information must be correct and readily understood by members of the public. Importantly, you are required to update each clinical trial record at least every 12 months. Please update “Record Verification” date every time when you update your record.

Procedure

This procedure is based on those provided by clincialtrials.gov. For more information on this procedure and the database's data fields, please use the help section once you have logged in to clinicaltrials.gov or follow the JRCO/SOP/022.

Description

Record Status

User is creating (or modifying) the record

In Progress

User has finished - record is ready for review

Completed

Administrator has reviewed record and has made any necessary changes

Approved

Administrator has released the record to ClinicalTrials.gov

Released

 

  • Review and make any necessary changes indicated by messages below the data fields on the Edit Protocol Record screen:

 ERROR messages indicate serious problems that need to be addressed.  WARNING messages indicate problems that need to be addressed.

 NOTE messages indicate problems that should be reviewed and corrected as needed.

  • After data entry for a record has been completed, enter any comments about the record for the JRCO (as the 'Administrator') and follow [Complete] in the Record Status area of the screen. This generates an automatic e-mail notification to JRCO that the record is complete.
  • JRCO will then review the record, approve and release it to clinicaltrials.gov.
  • Please note that we will send you a reminder if there are any errors with the record. We will not release the record for public viewing until these changes have been made.

 

1. Ask the JRCO to Create a User Account

  • To obtain a user account, please email the Joint Research Compliance Office requesting access at jrco@imperial.ac.uk. The JRCO will create your account and will log:

Login Name: [First name Initial] [Surname]

Full User Name: [First name] [Surname]

Password: you will need to change this when you first access the site

Email address: your standard Imperial email address (automatic notifications will be sent to this)

  • Your log in details will be sent to you automatically via email.

 

2. Log In

  • Go to https://register.clinicaltrials.gov.
  • Complete the three fields on the Login screen (as provided to you in the automatic email notification after your account was created): 

Organisation: ImperialC

Username: user login name Password: (case-sensitive)

Create a Record

  • A record may be created at a single session or created and saved for completion later. To create a record during a single session:
  • Follow [Create] from the Main Menu screen. Choose “New Record"
  • To create a record and save for completion later, use [Quit] to stop data entry after step b (above), or any other successive screen. Then use [Save Protocol Record] to keep your data. The record will be saved for later.
  • Further information please see JRCO/SOP/022