Page 336 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
Resources
ClinicalTrials.Gov and Protocol Registration and Results System (PRS)
1. ClinicalTrials.Gov Main Resource Home Page - https://clinicaltrials.gov/ct2/manage-recs
2. ClincialTrial.Gov Log-In Page -
https://register.clinicaltrials.gov/prs/app/template/QuickRefAdmin.vm?popup=true&uid=U000
4Q8X&ts=6&cx=-e7b5tx
3. Study Record Managers’ Information: https://www.clinicaltrials.gov/ct2/help/for-manager
4. Clinical Trials Registration and Results Reporting Taskforce - https://ctrrtaskforce.org/
5. Protocol Registration and Results System (PRS) Information -
https://clinicaltrials.gov/ct2/manage-recs/resources#ProtocolRegistration
6. Protocol Registration Data Element Definitions -
https://prsinfo.clinicaltrials.gov/definitions.html
7. Expanded Access Data Element Definitions -
https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html
8. Results Data Elements Definitions - https://prsinfo.clinicaltrials.gov/results_definitions.html
9. Interventional Study Protocol Registration Template -
https://prsinfo.clinicaltrials.gov/Interventional_Study_Protocol_Registration_Template_Jan_201
8.pdf
10. Observational Study Protocol Registration Template -
https://prsinfo.clinicaltrials.gov/Observational_Study_Protocol_Registration_Templ ate.pdf
11. Expanded Access Protocol Registration Template -
https://prsinfo.clinicaltrials.gov/Expanded_Access_Protocol_Registration_Template.pdf
12. Simple Results Templates and Results Data Preparation Checklists -
https://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html
13. PRS Guided Tutorials - https://clinicaltrials.gov/ct2/manage-recs/resources#GuidedTuts
14. PRS User’s Guide, Review Criteria, and Major Comments List -
https://clinicaltrials.gov/ct2/manage-recs/resources#ReviewCriteria
U.S. Laws, Regulations, and Guidance
1. Food and Drug Administration Amendments Act of 2007 (FDAAA) and Final Rule (42 CFR Part 11) - https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials- registration-and-results-information-submission
2. Final Rule (42 CFR Part 11) - https://www.govinfo.gov/content/pkg/CFR-2016-title42- vol1/pdf/CFR-2016-title42-vol1-part11.pdf
3. Section 801 of FDAAA - https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW- 110publ85.pdf