Policies, Procedures and Guidelines

Clinical Trials Registration and Informed Consent Posting Guideline

Created 2005
Administratively Revised 01/2019
Last Revised 11/2019

Washington University Guideline on Clinical Trials Registration Using Clinicaltrials.gov and Consent Form Posting Requirements

Washington University in St. Louis is committed to the public dissemination of the results of research conducted by its faculty. This guideline describes Washington University efforts to support the requirement to register clinical trials in accordance with public law and sponsor requirements. It also describes the process for posting consent forms on federally hosted websites as required by the 2018 Common Rule. The Food and Drug Administration Amendments Act (FDAAA) 801 (US Public Law 110-85) requires the registration of clinical trials using ClinicalTrials.gov. The NIH also requires that all clinical trials receiving full or partial funding must be registered. In addition, many scientific journals also require the registration of clinical trials as a requirement for publication.

Position Statement

Washington University faculty and staff who execute clinical trials subject to the FDA policy, the NIH policy, or the ICMJE policy should register (or ensure the registration of) all trials as required.

Requirements

Clinical Trials must be registered if any of the following three conditions are present:

  1. The FDAAA 801 and federal regulations (42 CFR Part 11) require the registration of the following types of studies:
    • Controlled, clinical investigations of drugs and biologics subject to FDA regulation, other than Phase I trials; and
    • Prospective clinical studies of health outcomes of devices subject to FDA regulation, other than small feasibility studies, but including pediatric post-market surveillance of devices ordered under section 522 of the Federal Food, Drug and Cosmetic Act.
  2. The NIH requires that all clinical trials receiving full or partial funding be registered. A statement to that effect (including the National Clinical Trial number assigned by ClinicalTrials.gov) must be in the Human Subject Portion of the renewal or competing continuation applications. New applications must indicate that any proposed clinical trial will be registered. The NIH defines a clinical trial as:
    • A research study in which one or more human subjects 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.
    • “For the purposes of this policy, the regulatory [42 CFR Part 11] definition [of clinical trial] and the definition in this policy are treated as synonymous. https://grants.nih.gov/policy/clinical-trials/definition.htm
  3. The policy of the International Council of Medical Journal Editors (ICMJE) requires the registration of all “clinically directive” trials that meet ICMJE definition that may wish to publish, must register prior to enrollment of the first participant. The ICMJE defines clinical trial as:
    • Trials that test a clinical hypothesis about health outcomes. These include any trials that assign human subjects to intervention and comparison groups to study cause-and-effect relationships between interventions and health outcomes. http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
    • Participating journals may refuse publications if the trials are not registered.
​Element FDA Final Rule​​ NIH Policy ICMJE Policy 2018 Common Rule

​Scope
​Applies to all “applicable clinical trials”: ​FDA regulated clinical trials (drug, biological, device products, and pediatric post-market device surveillance studies under FD&C Act).

Does not include Phase 1 studies or small device feasibility studies

​​Applies to all studies that meet the NIH’s expanded definition of a clinical trial

Applies to all “clinical trials” funded wholly or in part by NIH

Includes Phase 1 studies

Applies to all studies that meet the ICMJE definition of a clinical trial

Registration of non-trial studies is encouraged but not required

Applies to all “clinical trials” conducted or supported by a federal department or agency that applies the 2018 Common Rule

The 2018 Common Rule uses the same definition of a “clinical trial” as the NIH expanded definition


​Registration
​​​Must occur within 21 days of enrollment of 1st participant ​Must occur within 21 days of enrollment of 1st participant Must occur before enrollment of 1st participant N/A

Results Reporting​
​​Submission of results information must occur no later than 1 year after the completion date (referred to as the “primary completion date” of the clinical trial, which is defined as ​the date of final data collection for the primary outcome measure. ​​​Submission of results information must occur no later than 1 year after the completion date (referred to as the “primary completion date” of the clinical trial, which is defined as ​the date of final data collection for the primary outcome measure.​ Authors must meet the results reporting requirements of their funding and regulatory agencies One IRB-approved consent form used to enroll participants must be posted on a publicly available federal website after the study is closed to recruitment, but no later than 60 days after the last study visit by any participant

The two federal websites that currently satisfy this requirement are ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021)

Potential Consequences ​​​of Non-Compliance ​ ​If Federally funded, grant funding can be withheld

Civil monetary penalties of up to $12,000 per day

Record in ClinicalTrials.gov will be marked as non-compliant

​May lead to suspension or termination of grant or contract

Can affect future funding decisions

Record in ClinicalTrials.gov will be marked as non-compliant

The trial may not be eligible for publication in an ICMJE medical journal May lead to suspension or termination of grant or contract

Effective Date​
​​January 18, 2017

Compliance date is 90 days from the effective date.

​Effective for all competing application and contract proposals submitted on or after January 18, 2017 Effective for all trials that began enrollment after July 1, 2005

For trials that began enrollment prior to July 1, 2005, the trials must be registered prior to submission

Effective for all studies initiated on or after January 21, 2019

Also effective for ongoing studies if the IRB review has transitioned to the 2018 Common Rule requirements

Questions?
For more information, contact Michelle Jenkerson, Associate Director of the Center for Clinical Studies, at Jenkerson_m@wustl.edu or 314-362-5626.

Frequently Asked Questions (FAQs)

1. How do I know if my study requires registration?
2. Who is responsible for trial registration?
3. Who should complete results reporting?
4. How do I register on ClinicalTrials.gov?
5. What are the requirements?
6. How do I complete the record?
7. How long do I have To enter results?
8. Who should I contact locally with questions?
9. How do I know if I must post a consent form?
10. How do I upload a clinical trial informed consent form?
11. Which consent form should I post?
12. What if my consent form has information that shouldn’t be publicly available?
13. Are there exceptions to the consent form posting requirement?

1. How do I know if my study requires registration?

For help determining if a study is an “applicable clinical trial” under the FDA, see https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

For help determining if a study is a “clinical trial” under the NIH definition, see https://grants.nih.gov/policy/clinical-trials/definition.htm

For information on the ICMJE policy on clinical trials registration, see http://www.icmje.org/about-icmje/faqs/clinical-trials-registration.

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2. Who is responsible for trial registration?

The primary responsibility for registration of clinical trials and the posting of results resides with the Principal Investigator. Registration of applicable trials by Washington University investigators will be confirmed during any quality assurance activity.

Penalties for responsible parties who fail to register applicable clinical trials are significant and may include civil monetary penalties and, for federally-funded trials, the withholding or the recovery of grant funds.

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3. Who should complete results reporting?

Reporting of results is a cognitive task, not an administrative task. A member of the research team who is very familiar with all aspects of the study should complete the reporting requirements. It is recommended that the PI or the statistician complete the task.

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4. How do I register on ClinicalTrials.gov?

To register your trial on ClinicalTrials.gov, you must have a username and password.

Please submit requests for this information to ccsclinicaltrials@wusm.wustl.edu. Please give your full name, phone number, and email address. The administrator will issue a username and password which will be emailed to you by ClinicalTrials.gov.

Once you have received your username and password, go to http://register.clinicaltrials.gov to register your trial. The Organization name on the login page is WashingtonU.

The PI will be responsible for creating all new study registrations.  This is to ensure that the PI is the owner of the study record and will receive correspondence from clinicaltrials.gov.

To create the record, the PI will need to start the registration and enter the HRPO number as the Protocol ID, if available and the study title.  The PI can add other members of the research team to the “Access List” so they would be able to access the record.

In the Sponsor/Collaborator Section, you may select Responsible Party as “Sponsor” or “Principal Investigator”. If you select “Sponsor” this is a delegated person at WU as an Administrator that will receive an email from Cliniclatrials.gov to review and release the record once your record is complete. If you select “Principal Investigator” then you as the PI will receive an email from Cliniclatrials.gov to review and release the record, once the record is complete.

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5. What are the requirements?

Register the trial in ClinicalTrials.gov no later than 21 days after enrollment of the first participant.

Note: To publish in a ICMJE journal, you must register the study on ClinicalTrials.gov prior to enrollment of the first participant.

A record must be updated at least once every 12 months, and some data elements must be updated sooner (e.g., within 30 days of a change) based on the requirements in Section 801 of FDAAA and 42 CFR 11.64.  Open Protocol Section – Edit Study Status – Update “Record Verification Date”.

The following data elements must be updated not later than 30 calendar days after a change occurs:

Study start date Individual site status
Intervention name(s) IRB status
Availability of Expanded Access Completion Date
Expanded Access status Responsible Party
Overall recruitment status Official Title
Explanation for change in status Contact Information
Actual enrollment data

Results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Principal Investigator or designated study team member, no later than 12 months after the Primary Completion Date (The primary completion date is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.)

In the case of clinical trials with more than one primary outcome measure with different completion dates this term refers to the date on which data collection is completed for all of the primary outcomes.

Results for secondary outcomes must also be reported.

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6. How do I complete the record?

When completing your registration, please use the HRPO number as the “Protocol ID number.” This will make it easier for the Washington University administrators to identify, track, and assist you with questions or requests. If you are registering a new study, choose a Protocol ID number that will be familiar to you. Once you receive your HRPO number, you must change/edit the Protocol ID number to the study HRPO number.

After completing the record, please make sure to look it over and make edits in regard to any Warning, Error, or Problem messages that are automatically generated before submitting it for approval and release.

Once you have finished your submission, you must select “Entry Complete” at the top of the protocol record. The Washington University administrators will then receive an email. The submission will be reviewed to make sure all Warnings, Errors, and/or Problems with the record have been addressed. If so, it will be approved and released. If not, the administrator will send you an email asking you to correct the Warnings, Errors, and/or Problems identified.

After it is released, ClinicalTrials.gov will issue a ClinicalTrials.gov Identifier (NCT number) within 2 to 5 days. To obtain this NCT#, go to clinicaltrials.gov and search for your study. The identifier is found on the record.

Protocol records for active trials are required to be reviewed and modified as needed but at least every 12 months. Pay special attention to recruiting status and contact information as the accuracy and timeliness of this information is extremely important. Remember to update the Record Verification Date field in the Study Status section of your record.

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7. How long do I have to enter results?

Once the last subject has completed the study, the PI has 1 year to enter the results in the clinicaltrials.gov.  This requires the PI to enter all of the study outcomes which needs to include the statistics for all study outcomes (primary & secondary).  The study protocol and statistical plan must be uploaded for all studies completed after January 18, 2017.  The results section will require the PI and/or statistician to complete.

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8. Who should I contact locally with questions?

For more information, contact Michelle Jenkerson, Associate Director of the Center for Clinical Studies, at jenkerson_m@wustl.edu or 314-362-5626.

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9. How do I know if I must post a consent form?

The PI is responsible for posting the consent form..
There are three key factors to know if you must post a consent form from your study:

  • Is the study a “clinical trial”?
  • Is the study conducted or supported by a federal department or agency that applies the 2018 Common Rule?
  • Is the IRB review under “2018 Common Rule/Equivalent Protections”?
    • The Project Summary page of your study in myIRB shows whether “2018 Common Rule/Equivalent Protections” or “Pre-2018 Common Rule/Equivalent Protections” have been applied to your study.

If the answer to all three questions is “Yes”, you must post one IRB-approved consent form on a publicly available federal website.

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10. How do I upload a clinical trial informed consent form?

At this time, there are two publicly available federal websites that will satisfy the Common Rule’s consent form posting requirement:

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11. Which consent form should I post?

You may choose which consent form to post as long as it meets the following two criteria:

  • Must be an IRB-approved version of the consent document
  • Must be a version that was used to enroll participants

The posting can take place any time after the trial is closed to recruitment, so long as the posting is no later than 60 days after the last study visit by any subject (as required by the protocol).

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12. What if my consent form has information that shouldn’t be publicly available?

The Federal department or agency supporting the research may permit or require redactions of proprietary, sensitive or non-public information in the consent form (e.g., confidential commercial information). You should contact the Administrative Grant Specialist of the Federal department or Agency to inquire about the process for redacting such information from the informed consent form prior to posting.

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13. Are there exceptions to the consent form posting requirement? 

You should contact the Administrative Grant Specialist of the Federal department or Agency to request an exception to the requirement to post the consent form.

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Approval

1/14/2009 Approved by Samuel Stanley, Vice Chancellor for Research

11/1/2019 Approved by Jennifer Lodge, Vice Chancellor for Research