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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
Human Services (HHS) to issue regulations regarding certain statutory provisions and to consider possible expansion of the requirements through rulemaking.
Registration requirements established under the FDAAA reflect experience with the statutory requirements in the FDA Modernization act, as well as the International Committee of Medical Journal Editors (ICMJE) trial registration policy and other relevant U.S. and international policies.
The rule provides a checklist of mandatory registration data elements to allow responsible parties and members of the public to evaluate whether a study is an applicable clinical trial (ACT).
Under the statute, responsible parties, including, for example, grantee institutions, could be held accountable for noncompliance, with the potential for substantial civil monetary penalties, the withholding of grant funding from HHS agencies, and criminal proceedings.
At Children’s Health, Research Administration will be responsible to establish a PRS account for the institution and assist Children’s Health researchers will submission and reporting of results of applicable clinical trials meeting registration and reporting requirements.
4. PURPOSE
The purpose of clinical trial registration is to prevent selective reporting and publication of clinical trial and research outcomes. Additional reasons behind registration is to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to qualify and enrol, to help provide ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering, and promote more efficient allocation of resources. Before this requirement, investigators decided whether, when and how to report study results. Many clinical studies and outcome findings were never reported while some researcher’s “cherry picked” outcome measures and adverse events reporting; however, after ratification of FDAAA and NIH policies, registration and results reporting must be completed based on defined parameters as set by the regulation and legally defined timelines.
SOP No. 24, 07-14-2020, 05-31-2022