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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
ClinicalTrialsGov@Childrens.Com exists to register, manage, and communicate with key stakeholder within Children’s Health and with external collaborators. The below individuals have access to this e-mail account:
− Director of Research Administration,
− Quality Specialists Research Administration,
− Research Administration Coordinator, and
− Other staff as deemed by the Director of Research
Administration.
2. ClinicalTrials.gov will create a PRS account within 2 business days of receiving the application request. Once the account has been created, Children’s Health Research Administration “PRS Administrator” will receive an e-mail with instructions for logging in to PRS and for the management of ACTs.
Research User Accounts & Management of Updates and Reporting of Findings
1. For ACTs that require ClincialTrials.gov registration based on guidance from The Final Rule, NIH Policy on the Dissemination of NIH-Funded Clinical Trials, and International Committee of Medical Journal Editors (ICMJE), Director of Research Administration will assume the role of “PRS Administrator” and will grant Research User Accounts for applicable trials under the CMC PRS account.
2. As “PRS Administrator”, Director of Research Administration (or designee) will work directly with the Children’s Health Researcher to register, provide milestone updates, and deliver clinical trial results as required by The Final Rule documenting and reporting policies. The following table will be used to determine study registration:
SOP No. 24, 07-14-2020, 05-31-2022