ClinicalTrials.gov: Registering Studies and Submitting Results

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a “registry and results database.” ¹

For more information regarding the purpose of ClinicalTrials.gov, please visit “ClinicalTrials.gov Background”.

The NIH clinical trial definition is a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. ⁴

Refer to the following four guidance questions (or the NIH determination tool) to help determine
whether a study meets the definition of a clinical trial:
1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is Yes, the study meets the definition of a clinical trial

A ClinicalTrials.gov account is needed in order to register a study.  To create an account, complete the ClinicalTrials.gov Account Registration Request form.

An account will typically be created within 2 business days. Other study team members that require access to the record will also need to email their full name, Harvard email, Harvard School Affiliation (HSPH, HMS, HSDM), and phone number to AHarchelroad@hsph.harvard.edu to have an account created.

Once an account is created:

• ClinicalTrials.gov will email your account information and temporary password to the provided email address.
• When you have received your account information and temporary password, navigate to http://register.clinicaltrials.gov and input your username and password. For “Organization,” we recommend selecting either Harvard Medical School (HMS and HSDM) or Harvard School of Public Health. This will allow the ORARC HMS/HSDM/HSPH administrator to provide additional resources, such as accessing/viewing records, resetting passwords and sending reminders for flagged records. Next, click “New Record” in the top left of the Home page in the Quick Link section. Then follow the prompts to enter your protocol information.
• Note that the Principle Investigator is the Responsible Party for the study and should be listed as the Record Owner in ClinicalTrials.gov. However, the individual to originally create the record will automatically become the Record Owner for the protocol. If the Record Owner is someone other than the initial record creator, please update the record to accurately list the correct party.

NOTE: Important communication from ClinicalTrials.gov will be sent to the registered email address and should be checked regularly to avoid missed messages.

Email Amy Harchelroad at AHarchelroad@hsph.harvard.edu and she will notify you of your username, reset your password, or create a new account.

If your trial meets any of the following requirements, it must be registered on ClinicalTrials.gov by the Responsible Party.

FDA Requirements

NIH Requirements

ICJME Requirements

NOTE: If not listed above, please check with your sponsor regarding registration requirements and/or review the ClinicalTrials.gov FAQs for further information.

FDA Requirements

• A research protocol must be registered no later than 21 days after enrollment of the first participant. ¹

NIH Requirements

• A research protocol must be registered no later than 21 days after enrollment of the first participant. ¹

ICJME Requirements

• Registration is required at or before the time of first patient enrollment as a condition of consideration for publication. ²

Note: If not listed above, please check with your sponsor regarding registration requirements and/or review the ClinicalTrials.gov FAQs for further information.

Sections 46.102(b) and 46.116(h) of the revised Common Rule requires federally funded or supported clinical trials post one IRB-approved version of a consent form that has been used to enroll participants on a public federal website (such as ClinicalTrials.gov) designated for posting such consent forms.

The form must be posted after recruitment closes, and no later than 60 days after the last study visit.⁴

The following websites are available with further information:
NIH Grants & Funding: Posting Clinical Trial Informed Consent Forms
HHS Informed Consent Positing Instructions

Effective January 18, 1017 the HHS Final Rule (FDAAA 801) requires the public registration of clinical trials involving FDA-regulated products to ClinicalTrials.gov, including the publication of results, to ClinicalTrials.gov.

NIH Policy requires the public registration of all clinical trials funded wholly or partially by NIH, to ClinicalTrials.gov, including the publication of results.

Posting results on ClinicalTrial.gov depends on if the trial is determined to be an Applicable Clinical Trial (ACT) under the Final Rule of FDAAA (801). Please see the Applicable Clinical Trial Checklist to determine if your trial is subject to the Final Rule. ¹

For more information regarding publishing your results, please visit the ClinicalTrials.gov Frequently Asked Questions, “How to Submit Your Results” and “Why Should I Register and Submit Results”.

U.S. law requires some studies to submit results to ClinicalTrials.gov. Generally, results must be submitted within 1 year of the Primary Completion Date. ¹

For more information regarding results submission requirements, Please visit the Frequently Asked Questions on the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).

For more information regarding FDA submission requirements and penalties for non-compliance, please visit FDA’s Role: ClinicalTrials.gov Information.³

PRS recommends that your record be reviewed and verified once a year, at minimum ¹. We recommend that the record be checked for accuracy each time an IRB modification is submitted and approved. Incorporating your update into the modification process more easily triggers you to update your PRS record, reduces the likelihood of a large accumulation of changes, and reduces the likelihood that you will fail to update within the required 1-year period.

For more information regarding record updates, please visit the ClinicalTrials.gov Frequently Asked Questions, “How to Edit Your Study Record”.

The “Responsible Party,” a term defined in U.S. Public Law 110-85, Title VIII, Section 801, is ultimately held accountable for the submission and maintenance of the PRS record. At HMS/HSDM/HSPH, the Responsible Party is the Principle Investigator of the study.

Please note that neither Harvard Medical School (HMS and HSDM) nor Harvard School of Public Health should be selected as the Responsible Party. Studies that make this selection will be updated to the PI listed in the record.

For more information regarding the Responsible Party, please visit the ClinicalTrials.gov Frequently Asked Questions, “Responsible Party”.

Please email register@clinicaltrials.gov with your request and provide the following:

• ClinicalTrials.gov Identifier – This is the number that PRS assigned to the record upon its public release. It begins with “NCT” (e.g., NCT12345678).
• Organization name
• Individual Username – This is the username of the person who will be managing that particular record at the new organization as the new ‘Responsible Party’
• Grant Number – This number is only required if the study is NIH funded. ¹

For more information regarding transferring ownership of a record, please visit the ClinicalTrials.gov PRS User’s Guide, “Transferring a Record to/from a Different Organization”.

Further FAQs are available on the ClinicalTrials.gov website.

PRS has published a detailed Users Guide found at https://prsinfo.clinicaltrials.gov/prs-users-guide.html.

Contact the ClinicalTrials Help Desk directly at register@clinicaltrials.gov.

Or email the HMS/HSDM/HSPH ClinicalTrials.gov PRS administrator at AHarchelroad@hsph.harvard.edu.