Penn Medicine Clinical Research

ClinicalTrial.gov Registration

ClinicalTrials.gov, the largest online trial registration and results reporting repository in the world, includes published and unpublished studies and provides ethical, scientific and legal registration and reporting information. Study teams should register their studies in the Protocol Registration and Results Reporting System (PRS) at https://register.clinicaltrials.gov/

[See Chart Below] Answer the following questions to evaluate whether the study is an applicable clinical trial (ACT). If “Yes” is answered to all 4 questions, and the study was initiated on or after January 18, 2017, the trial would meet the definition of an ACT that is required to be registered under 42 CFR 11.22 [https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11]. Additionally, all NIH-funded awardees and investigators conducting clinical trials will register and report results of their trial in Clinicaltrials.gov [https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/reporting]

For more details: clinicaltrials.gov/ct2/manage-recs/background

 

Figure 1: Checklist for Determining Applicable Clinical Trials (ACT)

QUESTION YES NO
1. Is the study interventional (a clinical trial?
   Study Type data element is "Interventional" 

2. Do ANY of the following apply (is the answr "YES" to at least one of the following
    sub-questions: 2a, 2b, OR 2c)?

     a. Is at least one study facility located in the United States or U.S. territory?
         Facility Location - Country data element is "United States," "American Samoa,"
         "Guam," "Northern Mariana Islands," "Puerto Rico," "U.S. Virgin Islands," or 
         or other U.S. territory.

     b. Is the study conducted under a U.S. FDA Investigational New Drug application (IND)
         or Investigational Device Exemption (IDE)?
         U.S. Food and Drug Administration IND or IDE Number data elements is "Yes" 

     c. Does the study involve a drug, biological, or device product that is manufactured in and
         exported from the U.S. (or a U.S. territory) for study in another country?
         Product Manufactured in and Exported from the U.S. data element is "Yes"    

  
3. Does the study evaluate at least one drug, biological, or device product regulated by the United
    States Food and Drug Administration (U.S. FDA)?
    Studies a U.S. FDA-regulated Device Product data eleent is "Yes" and/or
    Studies a U.S. FDA-regulated Drug Product data eleent is "Yes"
4. Is the study other than a Phase 1 traial or drug and/or biological product or is the study other than a
    device feasibility study?
    For drug product trials, Study Phase data element is NOT "Phase 1" and for device product trials, 
    Primary Purpose is NOT "Device Feasibility."

National Institutes of Health. (n.d.). ACT Checklist for evaluating whether a clinical trial or study is an applicable clinical trial (ACT). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/manage-recs/act_checklist 

 

Figure 2: Registration Requirements for Specific Centers

Agency Studies
Food and Drug Administration Applicable ClinicalTrials*
National Institues of Health (NIH) All (NIH) funded studies evaluating a health-related
biomedical or behavioral intevention**
Center for Meicare and Medicaid Services Trials Billing for Services
Intenational Committee of Medical Journal 
Editors		 All Trials

Yale Center for Analytical Sciences. (n.d.). Trial registration. Yale School of Public Health. https://ysph.yale.edu/ycas/clinical-trials-gov/trial-registration/

 

Figure 3: Penalties for Noncompliance in Results Reporting

Agency Studies
Food and Drug Administration Civi monetary penalties of $11,000+/day
National Institues of Health (NIH) NIH funded withheld from the PI and the Institution
Center for Meicare and Medicaid Services Denial of claims
Intenational Committee of Medical Journal 
Editors		 Rejection of the publication

Yale Center for Analytical Sciences. (n.d.). Trial registration. Yale School of Public Health. https://ysph.yale.edu/ycas/clinical-trials-gov/trial-registration/

 

From Registration to Release

You can find the University of Pennsylvania’s policy here: https://irb.upenn.edu/

University of Pennsylvania's Protocol Registration and Results System (PRS) Administrators have access to all records within an institutional account. They create and modify user accounts, and assist users with all aspects of registration, updating and results reporting. If you have any questions, please use the information below to contact the appropriate Administrator. We are here to help!

To register for an account on the University of Pennsylvania’s ClinicalTrials.gov PRS, please fill out the following survey or contact a PRS Administrator: https://redcap.med.upenn.edu/surveys/?s=AXEARYD3JX

Frequently Asked Questions (FAQ)

The "sponsor" who initiated the trial (e.g., University of Pennsylvania) unless the study involves an FDA regulated drug, biologic, or device; then, the Principal Investigataor (PI) is the responsilbe party. 

Teams should register their studies before HIC approval, before the first subject is enrolled and with enough complete the registration and the review of your registration by ClinicalTrials.gov so that your study will be public.

Registrations must be released for ClinicalTrials.gov review. If the study involves an FDA-regulated drug, biolgic, or device, the PI mush release the study. The ClinicalTrial.gov team at UPenn will release all other studies.

ClinicalTrials.gov will send an email to the record owner (the PI of record) and to our ClinicalTrials.gov Team at the University of Pennsylvania.

Yes, contact the University of Pennsylvania ClinicalTrials.gov team if you need assistance.

Your record will appear on the ClinicalTrials.gov pubic website once ClinicalTrials.govapproves it. You can find the public website here: clinicaltrials.gov.