Important: The AVD Clinical Resource Library provides curated links to publicly available third-party documents. AVD Clinical does not host, own, or redistribute these materials. All resources remain the property of their respective organizations.
1. Nature of the Library
The AVD Clinical Resource Library is a curated index and reference directory. It organizes, annotates, and links to clinical research documents, templates, guidelines, and standards published by recognized organizations in the clinical research ecosystem, including but not limited to:
- U.S. Food and Drug Administration (FDA)
- International Council for Harmonisation (ICH)
- TransCelerate BioPharma Inc.
- National Institutes of Health (NIH)
- European Medicines Agency (EMA)
- National Center for Complementary and Integrative Health (NCCIH)
- Other public regulatory and research bodies
2. No Hosting or Redistribution
AVD Clinical does not host, store, copy, mirror, or redistribute any third-party documents. When you click "View Source" or similar links within the Library, you are directed to the original source document on the third party's own website or server. AVD Clinical has no control over the continued availability, accuracy, or accessibility of those external resources.
3. No Endorsement
Inclusion of a resource in the AVD Clinical Library does not constitute endorsement, recommendation, or validation of that resource for any specific use. AVD Clinical provides curation and commentary to help professionals navigate available resources — it does not verify that any resource is appropriate for your specific regulatory jurisdiction, study design, protocol, organization, or operational context.
4. Not Legal, Regulatory, or Clinical Advice
Nothing in the AVD Clinical Library constitutes legal advice, regulatory strategy, clinical guidance, compliance certification, or professional services of any kind. Always consult qualified legal counsel, regulatory affairs professionals, and your organization's compliance and quality teams before making regulatory, clinical, or operational decisions.
In particular:
- Regulatory guidance documents are subject to change and may not reflect the most current agency position.
- Template documents may require significant customization to meet your study's specific requirements.
- Compliance with ICH, GCP, FDA, EMA, or other standards depends on your specific implementation, not on access to reference documents.
- AVD Clinical commentary represents the editorial perspective of AVD Clinical staff and should not be relied upon as authoritative regulatory or legal interpretation.
5. Currency and Accuracy
While AVD Clinical makes reasonable efforts to keep Library entries current, we cannot guarantee that every linked resource reflects the latest version published by the originating organization. Regulatory guidance, templates, and standards are frequently updated. Always verify that you are using the most current version of any document directly from its source organization.
AVD Clinical is not liable for any decisions made based on outdated, superseded, or incorrectly linked resources.
6. Third-Party Terms and Copyright
All third-party resources are subject to the intellectual property rights, terms of use, and copyright policies of their respective owners. AVD Clinical makes no representation regarding your right to download, copy, reproduce, or adapt any third-party materials. Before using any third-party document in your operations, ensure your use complies with the source organization's terms.
| Organization | Copyright / Terms |
|---|---|
| FDA | Generally in the public domain as U.S. government works; confirm per document |
| ICH | ICH retains copyright; permitted use for non-commercial reference |
| TransCelerate | TransCelerate IP; templates available for industry use — review their license |
| NIH / NCCIH | U.S. government works; generally public domain |
| EMA | EMA copyright; open access for non-commercial use |
7. Compliance Disclaimer
AVD Clinical is designed to support HIPAA, GDPR, ICH-GCP, and 21 CFR Part 11-aligned workflows. However, final compliance depends on validated implementation, secure hosting, executed BAAs/DPAs, appropriate SOPs, access controls, staff training, audit logs, and organizational procedures. AVD Clinical does not certify, audit, or validate your organization's compliance with any regulatory requirement.
8. No Warranty
The Library is provided "as is" with no warranties, express or implied. AVD Clinical makes no warranty that the Library is complete, accurate, reliable, or suitable for any particular purpose. Use of the Library is at your own risk.
9. Reporting Errors
If you identify a broken link, outdated resource, or inaccurate annotation in the Library, please notify us at [email protected]. We appreciate the clinical research community's help in keeping the Library accurate.
10. Contact
AVD Clinical
Email: [email protected]
Phone: +1 929-502-4973
Website: avdclinical.com