This page provides step-by-step instructions on using clinicalTrials.gov for publishing details of clinical trials.
- An overview of the system
- Explains how the system is administered
- Advises on procedures
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 Ethics and Research Governance Coordinator is the College's designated 'Administrator' for registering trials on clinicalTrials.gov.
The Ethics and Research Governance Coordinator 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 Ethics and Research Governance Coordinator will also serve as the contact point for the ClinicalTrials.gov team and will assist with queries associated with trial information.
- You can register on ClinicalTrials.gov whether your main employment contract is with Imperial College or Imperial NHS Trust
Once your user account is created, you will be able to enter information about your clinical trial online.
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 6 months.
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.
1. Ask the Ethics and Research Governance Coordinator to create a user account
- To obtain a user account, you need to email the Ethics and Research Governance Coordinator requesting access
- The JRCO will create your account, we log your:
Login Name: [Surname][Initial]
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/Out
- Go to 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: organisation login name
Username: user login name
- To log out, select [Logout] from the Main Menu screen.
3. 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.
- Enter a Unique Protocol ID (DOCUMAS number) and Brief Title for your record on the Create New Protocol Record screen.
- Follow [Continue] to save data and proceed to the next screen. Repeat data entry and [Continue] for successive screens.
- After following [Continue] on the final data entry s creen (Links), use [OK] on the Study Completed screen.
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.
4. Data Entry Tips
- Brief Summary: Use language that is easily understood.
- Paragraph Sep aration: Leave a blank line between paragraphs (press enter twice).
- Create Lists: Keep e ach item on a separate line (press return after entering text for each line); bullet items by startin g each line with two spaces, a hyphen, and a space before entering the text; and press return after text for each item.
- Follow the link on any data entry field name to obtain a description of the field.
- Progress in creating the trial record is recorded as follows:
|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|
5. Submit a Record to the 'Administrator'
Follow [Modify] from the Main Menu.
Follow [Edit] next to the record you wish to submit.
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.
ALERT messages indicate problems that need to be addressed.
NOTE messages indicat e potential 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 us that the record is complete.
We 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.
6. Modify Record
- Use [Modify] on the Main Menu.
- Use [Edit] next to the re cord to be modified on the Select Protocol Record - Edit screen
- Locate the data field to be modi fied on th e Edit Protocol Record screen.
- Use on the corresponding [Edit] for that field.
- Make changes on the data entry screen.
- Use [OK] to save the changes and return to Edit Protocol Record.
- Update Verification Date.
7. View Record
Use [View] on the Main Menu.
Use [View] next to record to be displayed on the Select Protocol Record - View screen.
View Protocol Record is read-only.
8. Preview Record as it Appears on clinicaltrials.gov
Follow [Modify ] on the Main Menu.
Follow [Edit] next to the record to be previewed.
Follow [Preview] to see the record displayed similar to how it appears on clinicaltrials.gov.
Follow [Continue] to return to the Edit Protocol Record screen.
9. Delete Record
Follow [Modify] on the Main Menu.
Follow [Edit] next to the record to be deleted.
Follow [OK] on the Delete Protocol screen or use [Cancel] to return to the Edit Protocol Record screen without deleting the record.
A deleted record can be recovered via the [Undelete] option on the Main Menu.
10. Change Your Password
Use [Change password] on the Main Menu.
New password again for verification
Follow [Change Password] to save the new password.
Please contact us if you forget your password and we can send you a new one.