Rec Reg Requirements
42 CFR 11.28 regulations govern the registration information requirements that apply to which studies. The table “Applicability of Requirements in 42 CFR Part 11” can be used to assess whether the registration information requirements of 42 CFR Part 11 or Section 402(j) of the Public Health Service Act (PHS) apply to specific studies. (81 FR 65121) On many of our most popular trips, you may see more than one date. You can register on the date you want; However, if there are not enough registrations to meet our minimum requirements, you may be called and asked to change dates or placed on a waiting list. You have the option to decline and credit your leisure account or request a refund. 42 CFR 11.66 describes the potential legal consequences for responsible parties if they do not meet the applicable clinical trial registration and results filing requirements. These potential legal consequences include civil or criminal penalties, civil fines, and grant funding measures. If a nominated principal investigator no longer meets or can no longer meet all of a responsible party`s requirements, 42 CFR 11.4(c)(3) describes the mechanisms by which the sponsor becomes the responsible party in the event of withdrawal of that designation. This may be the case, for example, if a principal investigator dies, retires, changes jobs, or hands over control of clinical trial data to the sponsor.
A responsible party that submits information for a trial subject to voluntary submission requirements shall also submit information on certain other ACTs (referred to as “triggered trials”) if clinical trial information has not been provided ClinicalTrials.gov for those ACTs. These requirements are described in 42 CFR 11.60(a)(2)(ii), 42 CFR 11.60(b)(2)(ii), and 42 CFR 11.60(c)(2)(ii). No. FDAAA 801 applies to any clinical trial that meets the applicable definition of a clinical trial and that was initiated after September 27, 2007, or that commenced on or before that date and commenced on or before that date and was ongoing on December 26, 2007. FDAAA 801 does not distinguish between types of sponsors or funding sources when determining requirements for recording and submitting results. The requirements of 42 CFR 11.42 apply to applicable clinical trials for which a responsible party must submit information on results. Whether the outcome information requirements of 42 CFR Part 11 or Section 402(j) of the Public Health Service Act (PHS) apply to certain applicable clinical trials is determined by the primary completion date. Yes. The sponsor of the clinical trial, whether an individual or an institution, is the responsible party, unless the principal investigator has been designated as the responsible party in accordance with 42 CFR 11.4(c)(2).
The principal investigator may be appointed by a sponsor, provided that the principal investigator is responsible for the conduct of the trial, has access to and control of the clinical trial data, has the right to publish the results of the trial and is able to meet all the requirements of the Regulation relating to the submission and updating of clinical trial information. If the principal investigator does not meet the specified conditions to act as the responsible party, the sponsor cannot designate the principal investigator as the responsible party and the sponsor must remain the responsible party. If a sponsor of a clinical trial in a foreign country that does not meet the definition of an ACB and whose start date is after the effective date of the 42 CFR Part 11 regulations, decides to add a site in the United States (or its territories) and, therefore, the trial meets the definition of an ACT, the sponsor is subject to Section 402(j) of the Public Health Service Act and 42 CFR Part 11. The requirements set out in the regulations should be met, starting with the registration of the ACT no later than 21 days after the first participant registers on the US site. According to 42 CFR 11.22(b), “[a] clinical trial or study that at any time meets the conditions set forth in paragraph (b)(1) or (2) of this section shall be deemed to meet the definition of an applicable clinical trial.” Therefore, this study would become an ACT if it added the U.S. website. The registration information for clinical trials should contain information that applies to the whole trial, as is the case for all multicentre trials with information in ClinicalTrials.gov, since the entire clinical trial is considered the applicable clinical trial or medicinal product (see 81 FR 65013, 81 FR 65015). The 42 CFR 11.60 rule also establishes requirements for voluntary submission of outcome information that does not need to be submitted under 42 CFR 11.42. Many radiation-emitting equipment is subject to Section 510(k) of the FD&C Act and some are subject to Section 515 of the FD&C Act. If the product is a medical device intended to assist patients in treating or diagnosing a disease or condition that does not affect or manifest more than 8,000 people in the United States per year, it may meet the requirements of a compassionate device under Section 520(m) of the FD&C Act. FDA regulation in 21 CFR Part 892 describes the legal status (i.e., “classification”) of certain radiology equipment, including diagnostic and therapeutic devices.
For example, magnetic resonance diagnostic devices and medical load particle radiation therapy systems are designated as Class II devices (as defined in 21 CFR 860.3(c)(2)) in 21 CFR 892.1000 and 21 CFR 892.5050, respectively, and are subject to Section 510(k) of the FD&C Act.