ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:
- Any applicable human subject or ethics review regulations (or equivalent)
- Any applicable regulations of the national or regional health authority (or equivalent)
ClinicalTrials.gov is a publicly accessible database, which is free to register details of your clinical trials, regardless of the location where the trial is to take place. Before registering your study on ClinicalTrials.gov, please note the following conditions:
- If you want to register a study on ClinicalTrials.gov, you will need to post the study results on the website within one year of study completion, regardless of outcomes of the study and regardless of the publication status. Once the study has been entered onto ClinicalTrials.gov it becomes part of the public domain and we need to ensure results are reported, in accordance with best practice and in light of increased awareness and scrutiny around transparency.
- Once your study has been registered, you must log into ClinicalTrials.gov and verify that the information on record is still accurate at least every 6 months.
- If your study is registered on EudraCT, it it unlikely that it needs to be registered on ClinicalTrials.gov as well, unless any of the following applies:
- The study has a site in the USA.
- The study is evaluating a drug, biological, or device product which is regulated by the United States Food and Drug Administration.
- You would like to publish in a journal which requires that the trial has been registered on ClinicalTrials.gov prior to the enrolment of the first patient (the ICMJE stated that member journals will only consider a trial for publication if it has been registered before the enrolment of the first patient).
For further information please see SOP 022 on adding study details to public databases.
Creating an account
The Research Governance Integrity Team 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. We will check and release records for ClinicalTrials.gov to review once you have completed them properly. If you would like a user account, contact the Research Integrity Officer requesting an account to register your trial.
- Once the Research Integrity Officer has created an account for you, your log in details will be sent to you automatically from ClinicalTrials.gov via email and you will be able to register the trial.
- To register your trial on ClinicalTrials.gov you need to go to the PRS login page, not the main public view page.
- You can register on ClinicalTrials.gov whether your main employment contract is with Imperial College or Imperial NHS Trust.
Maintaining the study record
To Log In:
- Visit the PRS login page
- Complete the three fields on the login screen (as provided to you in the automatic email notification after your account was created):
Organisation: ImperialC or ImperialNHSTrust (depending on which organisation is sponsoring the study)
Username: user login name
To 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.
Information must be correct and readily understood by members of the public. You are required to update each clinical trial record every six months. Please update the “Record Verification” to that day’s date every time you login or update your record.