Clinical Trials

What is a clinical trial?

  1. Federally Funded Studies
    1. The study must involve human participants.
    2. The participants are prospectively assigned to an intervention.
    3. The study is designed to evaluate the effect of the intervention on the participants.
    4. The effect being evaluated is a health-related biomedical or behavioral outcome.
    6. Examples:
  2. FDA = Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.


What does the Clinical Trial Rule apply to?

  1. Most interventional studies of drug, biological, and device products that are regulated by the FDA. The requirements do not apply to Phase 1 trials of drug and biological products, or small feasibility studies of device products.
  2. All federally funded (including NIH) clinical trials. Includes Phase 1 clinical trials and trials that do not involve any FDA-regulated product such as trials involving only behavioral interventions.
  3. The International Committee of Medical Journal Editors (ICMJE) requires registration as a condition of the publication of research results generated by a clinical trial.
  4. Additional information about what trials should be registered and laws/policies requiring registration can be found at


Training requirements for clinical trials

  1. All investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP).
  2. Staff = Individuals, identified by the investigator, who are responsible for study design, coordination, data collection, and/or data management.
  3. To be completed prior to IRB approval of the clinical trial.
  4. UWM researchers will find GCP training online through CITI. Biomedical and social behavioral options are available.
  5. More information about training can be found at


Registering a clinical trial on (NIH-funded and FDA-regulated)

  1. Must be done no later than 21 days after enrollment of the first subject.
  2. Required information: descriptive information, recruitment information, location and contact information, and administrative data.
  3. The record must be updated at least once every 12 months.


Posting the results on (NIH-funded and FDA-regulated)

  1. Results must be posted no later than 12 months after primary completion date; possible delay of up to an additional two years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance for a new use is being sought.
  2. The following information must be posted: participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, protocol and statistical analysis plan, and administrative information.


Posting the consent form (Federally funded)

  1. For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal website that will be established as a repository for such informed consent forms.
  2. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal website (i.e., confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
  3. The informed consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
  4. The approved websites for posting the informed consent form are:
    1. – Please see instructions below
    2. A docket folder on (Docket ID: HHS-OPHS-2018-0021) – Additional information and instructions for posting can be found here.


Who is responsible for registering and posting results on or posting the informed consent form?

  1. The principal investigator


Consequences of not following the posting requirements

  1. Identifying the clinical trial record as non-compliant in
  2. May impact federally funded studies.
  3. May be considered in future funding decisions.
  4. Civil monetary penalties of up to $10,000 per day.


Effective dates for studies requiring clinical trials registration and GCP training

  1. NIH-funded and FDA-regulated – January 1, 2017
  2. Federally funded – January 21, 2019


Instructions for registering a clinical trial

  2. Request a account
    1. Email
      1. Subject line = account request
      2. Email should include your name, email address, telephone number, study title, and UWM IRB #
    2. After 1-3 business days you will receive an email with a temporary password to
  3. log in instructions
    1. Go to
      1. Enter Organization: UWisconsinMilwaukee
      2. Enter your user name
      3. Enter your password
      4. To update your password select Accounts on the main page
  4. Register your study and enter the required elements. Helpful information and instructions can be found at
  5. Be sure to update your record at least once every 12 months. See #5 and/or #6 above for required information. Additional information can be found at


NIH requirements and instructions can be found at