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Because of a lapse in Government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.

Updates regarding Government operating status and resumption of normal operations can be found at OPM.gov.

NCCIH Clinical Research Toolbox 508-Compliant PDFs

The following PDFs are fully accessible versions of the Word documents presented for the NCCIH Clinical Research Toolbox, when that document could not be made fully compliant in Word. Please see the full NCCIH Clinical Research Toolbox for descriptions of these files and more.

Clinical Research Start Up

Data Safety and Monitoring

Study Accrual and Retention Plan Template

Case Report Forms

Protocol Associated Documents

Essential Documents/Regulatory Binder

Pharmacy/Investigational Product

Quality Management

Documents Used During the Conduct of Clinical Research

Milestone Documents

Back to the NCCIH Clinical Reserach Toolbox