Last updated: November 2026
A ClinicalTrials.gov reporting program organizes trial identification, responsible-party assignments and registration, results and update deadlines under 42 CFR Part 11. It serves sponsors and institutions employing investigators. Integral Healthcare Solutions (IHS) drafts the inventory, procedures and deadline calendar for the research office and counsel to approve; the institution enters its own data.
What does 42 CFR Part 11 require?
Under 42 CFR Part 11, Clinical Trials Registration and Results Information Submission, registration is required for applicable clinical trials initiated after September 27, 2007, or initiated on or before that date and ongoing on December 26, 2007. Results and updates follow the conditions below. Page opened November 5, 2026; eCFR build November 4, 2026; Title 42 last amended October 8, 2026.
| Step | What Part 11 says | Section |
|---|---|---|
| Registration | Generally, the later of December 26, 2007, or 21 calendar days after first enrollment. Section 11.24(b) changes the historical date for non-serious conditions and uses FDA plan approval for pediatric device surveillance that is not a clinical trial. | 11.24 |
| Results | Generally within 1 year after primary completion for trials covered by section 11.42, unless waived under 11.54. Coverage includes specified earlier trials of approved products. For pediatric device surveillance that is not a clinical trial, results are due within 30 calendar days after submission of the final report to FDA (11.44(f)). | 11.42, 11.44 |
| Delay with certification | A certification must precede the standard 1-year deadline and meet the new-use or initial-approval conditions in section 11.44(b) or (c). Those provisions specify the qualifying events and earliest-event deadlines; the 2-year limit after certification is subject to the partial-results exception in 11.44(d). | 11.44(b), (c) |
| Extension or waiver | A good-cause extension request must precede the applicable deadline. For primary completion on or after January 18, 2017, a waiver request must precede the standard 1-year deadline and explain extraordinary circumstances and consistency with public-health protection or national security (11.54(a)); earlier trials follow 11.54(d). | 11.44(e), 11.54 |
| Updates | For covered trials initiated on or after January 18, 2017: registration changes generally at least annually, with faster deadlines for specified fields. Record verification updates accompany every complete accuracy review and occur at least annually. See 11.64(a) for all triggers and when duties end. | 11.64(a) |
| Corrections | Correct or address all identified errors, deficiencies and inconsistencies within 15 calendar days for registration or 25 for results, measured from the date the electronic notice is sent. | 11.64(b)(1) |
Primary completion is final primary-outcome data collection from the final subject, including terminated trials; with multiple primary outcomes, all must be collected. For pediatric device surveillance that is not a clinical trial, it is submission of the final report to FDA (section 11.10). Section 11.44(d) governs later collection of secondary outcomes or additional adverse-event information.
Which trials are applicable clinical trials?
An applicable clinical trial is an applicable drug clinical trial or an applicable device clinical trial; expanded access use is not one (section 11.10(a)). For a trial initiated on or after January 18, 2017, section 11.22(b) treats a trial that at any point meets these conditions as applicable:
- Drug or biological product. One or more arms; interventional; a phase other than phase 1; studies a U.S. FDA-regulated drug product; and at least one facility in the United States or its territories, a studied product manufactured there and exported for study in another country, or an FDA IND number.
- Device. One or more arms; interventional; primary purpose other than a feasibility study; studies a U.S. FDA-regulated device; and at least one facility in the United States or its territories, a studied product manufactured there and exported for study in another country, or an FDA IDE number. FDA-required pediatric postmarket surveillance under section 522 also counts.
Trial initiation is first enrollment; for pediatric device surveillance that is not a clinical trial, it is FDA approval of the surveillance plan (section 11.22(a)(3)).
Who is the responsible party?
Each trial has one responsible party: the sponsor, unless and until a principal investigator has been designated (section 11.4(c)). The IND or IDE holder is the sponsor; without one, the sponsor is the single person or entity that initiates the trial and has authority and control over it.
A sponsor may designate a principal investigator only if that principal investigator is responsible for conducting the trial, has access to and control over the data, has the right to publish the results, and can meet all the submission and update requirements. The sponsor obtains the investigator's acknowledgment of those responsibilities, and the investigator acknowledges the designation to the Director in the registry's format. If the investigator stops meeting the conditions, the sponsor must withdraw the designation in the registry-specified format and is again responsible unless and until it makes a new qualifying designation (section 11.4(c)(2) and (3)). Identity and contact information are submitted with the registration (section 11.4(b)).
What happens if a deadline is missed?
Failure to submit required information is prohibited under section 301(jj)(2) of the Federal Food, Drug, and Cosmetic Act and can lead to civil monetary penalties (section 11.66(a)(2), (b)). Compliance with the registry's quality-control process is not a legal defense (section 11.64(b)(3)).
- Penalty maximums. 45 CFR 102.3 lists, in its 2025 column, a maximum of 15,107 dollars for all violations adjudicated in a single proceeding and 15,107 dollars for each day a violation is not corrected after a 30-day period following notification. Page opened November 5, 2026.
- Grant funding. For HHS-funded applicable clinical trials, required grant or progress reports must certify required submissions. Remaining or future grant funds are withheld if submissions for trials for which the grantee is responsible are not verified; confirmed noncompliance triggers agency notice and 30 days to correct (11.66(c)).
- FDA process. FDA's August 2020 guidance (nonbinding; opened November 5, 2026) describes a Pre-Notice Letter generally requesting action within 30 calendar days after receipt. If FDA then determines a violation exists, a Notice of Noncompliance allows 30 calendar days after notification to remedy it. If unresolved 30 calendar days after receipt, FDA generally intends to seek penalties, considering the violation and remediation circumstances.
Who needs this program, and what triggers it?
IHS offers this service to institutions coordinating registration and reporting across staff. Situations to assess include:
- Investigator-initiated trials where no one records whether the four designation conditions are met.
- A designated investigator can no longer meet the designation conditions; the sponsor must withdraw the designation, with changes updated under section 11.64(a).
- An HHS-funded applicable clinical trial requiring submission certifications in required grant or progress reports.
- An electronic quality-control notice requiring correction or response within 15 calendar days for registration or 25 for results, from its sent date.
How does IHS help?
IHS assesses gaps, maps documents and evidence to Part 11, drafts procedures and clinical content for the client's clinicians and counsel to approve, and supports readiness through a mock review:
- Gap assessment of procedures and a sample of trial files against Part 11.
- Trial inventory format covering product type, IND or IDE number, first enrollment, primary completion date and responsible party.
- Applicability checklist built on sections 11.10 and 11.22.
- Designation and withdrawal forms tied to section 11.4(c).
- Reporting calendar for the registration, results, update and correction clocks, then a readiness review of sample files.
The institution supplies its trial list, sponsor agreements and existing procedures; leaders and counsel approve every document.
What to have ready
IHS suggests the following preparation list, mapped to 42 CFR Part 11, eCFR build November 4, 2026; page opened November 5, 2026:
- Trial inventory and applicability determinations (11.22).
- Sponsor and responsible-party records (11.4).
- Designation acknowledgments, qualification evidence and withdrawal procedure (11.4(c)).
- Registration calendar including exceptions (11.24).
- Results calendar covering certifications, extensions and partial results (11.44).
- Separate waiver-request tracking (11.54).
- Update, verification and correction procedures (11.64).
- Required HHS grant-report certifications for applicable clinical trials (11.66(c)).
If several items are missing, bring the list to the free introductory call and IHS will scope the work around your timeline.
How does it compare with other ways to run it?
An institution can run the process centrally in the research office, leave each investigator to handle their own trials, or hire an outside firm to prepare and enter data. Part 11 puts the duty on the responsible party in every case, so the structure changes who does the work, not who is answerable.
What does it cost?
The ClinicalTrials.gov FAQ lists a study-listing charge of 0 dollars (page opened November 5, 2026). Verify current fees with the National Library of Medicine. IHS scopes each engagement after a free introductory call.
What this is not
- Not legal advice. IHS is a consulting firm, not a law firm, and counsel decides whether a trial is subject to the rule.
- Not data entry. IHS does not enter data on ClinicalTrials.gov or contact NIH, FDA or the registry.
- Not a guarantee against enforcement or a prediction of what FDA or NIH would do.
Frequently asked questions
What does 42 CFR Part 11 require?
It assigns registration, results and update duties to responsible parties for covered trials. Registration is generally due by the later of December 26, 2007, or 21 calendar days after first enrollment, subject to section 11.24(b); results generally within 1 year after primary completion, subject to sections 11.42, 11.44 and 11.54.
Which trials are applicable clinical trials?
An applicable clinical trial is an applicable drug clinical trial or an applicable device clinical trial, and expanded access use is not one. Section 11.22(b) sets the test for trials initiated on or after January 18, 2017. Counsel should confirm each trial.
Who is the responsible party?
For a clinical trial, the sponsor is responsible unless it designates a qualifying principal investigator under section 11.4(c)(2), including both required acknowledgments. That investigator must conduct the trial, have access to and control over its data, hold publication rights and be able to meet submission and update requirements.
Can results submission be delayed?
Certifications under section 11.44(b) or (c) must precede the standard 1-year deadline; their 2-year limit after certification excepts partial results under 11.44(d). Good-cause extension requests must precede the applicable deadline. A waiver excuses specified requirements if granted; section 11.54(a) requires a request before the standard 1-year deadline for trials with primary completion on or after January 18, 2017.
What happens if a deadline is missed?
Failure to submit required information is prohibited under section 301(jj)(2) of the Federal Food, Drug, and Cosmetic Act and can lead to civil monetary penalties. Section 11.66(c) also withholds remaining or future grant funding when required submissions for HHS-funded applicable clinical trials for which the grantee is responsible are not verified; confirmed noncompliance triggers notice and 30 days to correct.
How often must a registered record be updated?
For covered trials initiated on or after January 18, 2017, registration changes are generally updated at least annually; section 11.64(a) sets faster deadlines for specified fields. Overall recruitment changes require updates within 30 calendar days, including a reason if suspended, terminated or withdrawn. Actual primary completion requires an update and actual enrollment within 30 calendar days after completion; responsible-party, title and contact changes also have 30-calendar-day deadlines. Record verification updates accompany every complete accuracy review and occur at least annually, until the update obligation ends under section 11.64(a)(3).
What should an institution's written procedure contain?
A trial inventory, an applicability determination per trial, designation and withdrawal steps, a registration step, a results calendar, an update schedule and a path for correction notices. IHS drafts these for the research office and counsel to approve.
What does IHS draft, and what does the institution submit?
IHS drafts the gap assessment, inventory format, applicability checklist, designation forms, procedures and calendar. The institution and its counsel approve them, enter their own data on ClinicalTrials.gov and deal with NIH and FDA. IHS does not.