Guide to Good Clinical Practice: Need information on setting up or running clinical trials?
The Guide to Good Clinical Practice can be a valuable reference if you're working on a clinical trial for new drugs, devices or biologics or are researching the clinical trials' process and regulations. The Guide to Good Clinical Practice includes:
- Explanations of laws, federal regulations, and international harmonization efforts
- Sample checklists for conducting quality assurance audits
- FDA forms, compliance guides, and informational charts
- Industry guidance documents and information sheets
- Analyses of accepted good clinical practices
- Newsletters with key updates and analysis
- Clinlaw, an online database of state and federal clinical trial requirements
The FDA forms, compliance guides, and organizational charts are located under the Additional Resources tab on the main page along with Clinlaw, Guidance Documents, court cases, and other resources. The online Guide to Good Clinical Practice is a very current and comprehensive resource. You can locate specific information by:
- Using the search box to find information within the Guide, newsletters or selected Federal regulations or statutes or
- Navigating to any page in the database using the full table of contents on the left side of the screen
The Guide to Good Clinical Practice is available from both our E-Texts and E-Databases pages. Off-campus access is available through the VPN/GWireless or ALADIN. If you have questions regarding off-campus access, please consult the online instructions or contact the Reference Desk via phone (202-994-8570), email (library@gwumc.edu), or Instant Message.
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