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Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. The law applies to certain clinical trials of drug, biological, and device products regardless of the source of funding and has been in effect since September 27, 2007. The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) dated September 21, 2016 clarifies and expands the regulatory requirements and procedures for submitting clinical trial registration and results.

Determine if you need to register your study by using this Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial.

If it is determined that the clinical trial is not an Applicable Clinical Trial, it should not be registered.

Where to Register

Clinical studies are registered on ClinicalTrials.gov via a Web-based data entry system called the Protocol Registration and Results System (PRS) that can be accessed at https://register.clinicaltrials.gov. You must have a PRS account to register a clinical study or submit results information for a registered study.

For first time registration or if you forgot your username please contact Tufts University PRS account administrator Jordan Wilkinson in Research Administration & Development at the Office of the Vice Provost for Research. Tufts University organization must be entered at PRS login as “TuftsU”.

Additional information for study record managers related to entering information in PRS is available here.

Study Sponsor and Responsible Party

The study “Sponsor” is not the entity that provided funds for the clinical trial. “Tufts University” should be entered as a Sponsor of clinical trials at Tufts University.

FDAAA 801 and the Final Rule states that as long as the Principal Investigator (PI) is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet the requirements for the submission of clinical trial information, the PI should be designated as the responsible party for registering a clinical trial and submitting results to clinicaltrials.gov.

To this end, the “Responsible Party” of each clinical trial at Tufts University should be designated to the respective clinical trial’s Principal Investigator.

The Principal Investigator (as Responsible Party) must keep staff information and access on the record up to date, removing departed study team members and requesting PRS accounts for new staff members. When the Principal Investigator and designated study team members depart Tufts University or study team members are no longer assigned to the study which is the subject of the registration, the Principal Investigator must ensure the update of staff contact information or, in the event of Principal Investigator departure, notify Tufts PRS account administrator to take necessary action regarding the user account and record.

PRS Study Record

Each study record should include a summary of the study protocol, including the purpose, recruitment status, and eligibility criteria. Study locations and specific contact information are listed to assist with enrollment. Some study records include summary study results in a tabular format. The results information submitted to ClinicalTrials.gov includes the number of participants starting and completing the study, baseline characteristics, outcome measures, and adverse events. See PRS information for researchers and PRS information for study record managers for more information.

After the study record is released (submitted) by Tufts and before its publication on the site it will be reviewed by a ClinicalTrials.gov staff member. This review focuses on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. The researcher may be asked to clarify items or make corrections to the record before publication. Ensuring that the record is consistent with the ClinicalTrials.gov protocol review criteria before releasing it will expedite publication on the site.

Required Registration Updates

Responsible Parties should update their records within 30 days of a change to any of the following:

As described in 42 CFR Part 11, additional information must also be updated within 15 or 30 days of a change. Other changes or updates to the record must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

The Responsible Party receives messages from the clinicaltrials.gov system requesting a correction of any issues or an update to the record.

See How to Edit Your Study Record for details on updating study information.

Transfer of Registration Records

If the Responsible Party changes or departs Tufts University, an account or the registration record may need to be transferred to the Responsible Party’s new institution. Transfer depends on the IRB review, grant ownership, study status, and status of the Responsible Party as Investigator-Sponsor.

 

If the Responsible Party departs Tufts University, but the registration record is not transferred to the new institution, the Responsible Party and department/school/center must have a clear plan for ensuring timely completion of all requirements associated with the record. This may include designation of a new Responsible Party or data custodian within the department/division with access to all necessary information and data. 

Links and Resources

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)

Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11)

Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial

Frequently Asked Questions

ClinicalTrials.gov Training Materials

PRS information for researchers

PRS information for study record managers

ClinicalTrials.gov protocol review criteria

How to Edit Your Study Record