ClinicalTrials.gov
ClinicalTrials.gov
Support to get your study registered on ClinicalTrials.gov.
Support we provide:
- Determining if your study should be registered.
- Identifying required consent language address the CT.gov registration
- Guidance for protocol registration and result reporting
- Troubleshooting for registration and result reporting errors
- Providing quarterly communication reports to Department Chairs and Associate Deans of Research regarding problem records.
Request support with ClinicalTrials.gov registration, results reporting, or addressing problem records.
FAQs
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ClinicalTrials.gov (CT.gov) is a publicly available online clinical trial database that includes details about clinical trials and their corresponding study results. This database is owned by the National Institutes of Health (NIH) National Library of Medicine (NLM).
Federal Laws and various policies/guidelines mandate that specific clinical trials must be registered and have their results reported, including:
- Food and Drug Administration Amendments Act (FDAAA 801)
- 42 CFR 11 Health and Human Services (HHS) Final Rule
- National Institutes of Health (NIH) Policy on the Dissemination of NIH-Funded Clinical Trial Information
- International Committee of Medical Journal Editors (ICMJE) (2005) guidelines
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CT.gov benefits both patients and health care professionals to find studies that patients may be able to participate in and learn more about clinical research. It also benefits researchers looking for studies available on a specific topic, identify unmet research and medical needs and see if results are reported and match the research plan.
Registration and results reporting for clinical trials allow researchers to be good stewards of research data and funding.
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Registration requirements are dependent on the type of study being conducted, the funding agency and the publication companies for the trial. An independent evaluation determining registration requirements should be conducted by the study sponsor for each clinical trial. For Investigator Initiated Trials (IITs) the Principal Investigator (Sponsor-Investigator) is responsible for making this determination.
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Federal Regulations require all Applicable Clinical Trials (ACT) to be registered, with results reported, in CT.gov. To check your study, use this Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF).
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The NIH requires all Clinical Trials that are funded, in whole or in part, by the NIH to be registered in CT.gov. This is more encompassing than the FDA Regulations and may require registration for NIH Funded studies even if the study does not fit the definition of an Applicable Clinical Trial. Determine if your NIH-funded human subjects research study meets the NIH definition of a clinical trial.
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Requires all Clinical Trials that study the relationship between a health-related (biomedical or other health related, including behavioral or educational programs) intervention and health outcome to be registered in CT.gov.
Other funding sources may have different registration requirements and those specific requirements should be considered when making this determination. In addition, research being completed outside of the United States may have different laws regarding registration and results reporting. Additionally, studies that do not fit the criteria above are permitted to still be registered and have results reported.
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The study sponsor is the Responsible Party and are the ones responsible for registration and results reporting. In some cases, they may delegate this responsibility to a site principal investigator, if specific criteria outlined in FDAAA 801 are met.
For Investigator Initiated Trials (IIT), where the investigator both initiates and conducts the study, the study sponsor will be the principal investigator and they are responsible for registering and results reporting in CT.gov.
Record owners are personnel who can assist with the registration and results reporting for a clinical trial. Record owners may be members of the study team or a designated staff member. While the record owner may assist with registration and results reporting the responsible party (study sponsor) is responsible for ensuring the information is accurate and releasing the information for PRS posting.
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CT.gov contains two interfaces, one is the publicly available interface which can be accessed at ClinicalTrials.gov, one is the back-end interface called, PRS, where clinical trials can be registered. The registration site can be accessed https://register.clinicaltrials.gov.
When logging in to the PRS system please use the following organization names:
- For oncology studies: Ohiosuccc
- For all other studies: OhioU
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Contact your college PRS Administrator. They can assist with creating your individual account, password issues or any questions.
PRS Administrators at Ohio State
College of Arts and Sciences - Jared Port
College of Dentistry - Tina Adathakkar
College of Education and Human Ecology - Kim Lightle
College of Food, Agricultural, and Environmental Sciences - Melissa Burant and Lori Kaser
College of Medicine - COM Research Compliance
College of Nursing - Mary Beth Happ and Sandra Solove
College of Optometry - Karla Gengler-Nowak
College of Pharmacy - Jeanne Green
College of Social Work - Elysabeth Bonar Bouton
Comprehensive Cancer Center - Lisa Brenner
All other colleges - Sandra Meadows
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Login to your PRS account and reference the PRS User Guide for detailed instructions on how to register your study, address problems and complete results reporting.
Data Elements that are specific to Ohio State research include the following:
- Protocol ID – This should be the Ohio State IRB #
- Secondary IDs – This should be the Federal Grant # or other ID. Include the name of the funding agency. For example: “R01-5555-555 NIH-NCATS”.
For each trial it will take approximately eight hours to complete the initial registration, approximately two hours for each update and approximately 60 hours for results reporting.
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ClinicalTrials.gov training is available to all study team members to help identify and understand their responsibilities for:
- CT.gov registration
- CT.gov results reporting
- CT.gov required updates for clinical trials
Breakdown of Recommended Modules
To access the training:- Log in to CITI
- Scroll down to the “Learner Tools for Ohio State University” box
- Click “Add a Course”
- Check “Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov”
- Click “Submit”
- Find the course under “Courses Ready to Begin” and select “Start Now”
- Complete the training modules
In addition to the CITI training module additional training opportunities are provided by the National Library of Medicine on the ClinicalTrials.gov Support and Training Materials webpage.
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It is recommended to complete the CT.gov registration before your first enrollment. Federal regulations require registration to be completed within 21 days of enrollment for the first participant, but some journals require registration to be completed prior to the first enrollment to publish.
Updates to the record must be made at least on an annual basis, even if nothing has changed. Updates to the record should be completed within approximately 30 days if there are changes to the study plan or study status.
Study Results must be reported within one year of reaching the primary completion date. This is the date the final participant was examined or received an intervention for the purpose of final collection of data for the primary outcome. This date may or may not correlate to the last study visit or last study procedure.
In addition to submitting the study results a copy of the study protocol, the statistical analysis plan, and a blank copy of the consent form, that was used during the study, are required to be uploaded within one year of reaching the primary completion date.
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Monetary penalties may occur for not registering a protocol, not submitting study results, submitting false or misleading information, failing to submit the required certification to the FDA or knowingly submitting false certification information to the FDA.
These penalties may amount to $13,000/day of noncompliance or impact future and existing NIH funding for the responsible party or The Ohio State University as a whole.
If issues are not resolved other regulatory or enforcement actions could take place such as injunctions or criminal prosecutions.
Additional Resources
Institutional Resources
Ohio State ERIK Research Responsibilities and Compliance ClinicalTrials.gov Training
Ohio State ERIK Research Responsibilities and Compliance Clinical Trials Registration
Ohio State ERIK Research Responsibilities and Compliance Consent Template Language by Topic
Regulations, Policies, and Guidelines
Clinical Trials Registration and Results Information Submission (42 CFR 11) (Final Rule)
Clinical Trial Databases Food and Drug Administration Amendments Act (FDAAA 801) (PDF)
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
International Committee of Medical Journal Editors (IMCJE) (2005) Guidelines
World Health Organization (International Clinical Trials Registry Platform [ICTRP])