Resources

Below is an alphabetical listing of useful reference materials and websites available to researchers at Christiana Care Health System (CCHS).

General Resources

Resources

Department of Health and Human Services Clinical Trials Registration and Results
Information Submission 42 CFR Part 11

2 CFR Part 200
Uniform Administrative Requirements Costs Principles and Audit Requirements for Federal Awards 
2CFR Part 200 

Title 45 Code of Federal Regulations Part 74, Appendix E 
Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals
45 Code of Federal Regulations, Part 74, Appendix E

International Committee of Medical Journal Editors
Clinical Trials Registration
ICMJE

NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html

US Food and Drug Administration Office of Good Clinical PracticeFDA’s Role: ClinicalTrials.gov Information
Office of Good Clinical Practice 

US Public Law 110-85   
Title VIII Clinical Trial Databases Section 801 Expanded Clinical Trial Registry and Data Bank
FDAAA 801 Requirements

NIH Grants Policy statement
https://grants.nih.gov/policy.index.htm

National Science Foundation
https://www.nsf.gov/bfa/dias/policy/

Online Grant Management for NSF
https://www.research.gov/research-portal/appmanager/base/desktop?_nfpb=true&_pageLabel=research_home_page\

Code of Federal regulations Title 21
Code of Federal Regulations (21CFR54), Financial Disclosure by Clinical Investigators

Code of Federal Regulations Title 21 Code of Federal Regulations (21CFR 312), Investigational New Drug Application
Code of Federal Regulations Title 21 CFR 312

Code of Federal Regulations Title 21 Code of Federal Regulations (21CFR 812), Investigational Device Exemptions
Code of Federal Regulations Title 21 CFR 812

International Conference on Harmonization Good Clinical Practice Guidelines Investigator Responsibilities
ICH GCP’s Investigator

Anti-kickback law
https://www.ssa.gov/OP_Home/ssact/title11/1128B.htm

CMS Physician Self-referral
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/

Stark Law
https://starklaws.uslegal.com/the-stark-act/

Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought
Code of Federal Regulations (42CFR50, Subpart F)

Responsible Prospective Contractors
Code of Federal Regulations (45CFR94)

Financial Disclosure by Clinical Investigators
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=54

Era Commons Login for NIH grants
https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-HTTPS%3a%2f%2fp

Uniform Guidance Website
https://www.ecfr.gov/cgi-bin/text-idx?SID=ed90f54836feb6a994f657188eb05e33&node=2:1.1.2.2.1&rgn=div5