Disclaimer
Last updated February 2026. Please read these terms carefully before relying on any content from this site for your clinical research work.
The CRC Toolkit is an independent, educational resource for the clinical research coordination community. This page describes the scope of the site's content, its limitations, and the terms under which it is provided. By using this site, you agree to the conditions described below.
Educational Purpose Only
All content on The CRC Toolkit — including blog posts, calculator tools, guides, certification preparation materials, and reference content — is published for general educational and informational purposes only. Nothing on this site is intended to constitute, replace, or supplement formal training, sponsor-issued protocol guidance, institutional Standard Operating Procedures, sponsor-required certifications (such as Good Clinical Practice), or the professional judgment of a licensed clinician or qualified regulatory professional.
Not Medical Advice
Nothing on this site is medical advice. Calculator tools (drug accountability, creatinine clearance, visit windows, date arithmetic, unit conversion) are data entry aids only. They are intended for clinical research coordinators preparing source documentation under the supervision of a qualified principal investigator and within the scope of an IRB-approved protocol. Calculator output must be independently verified against the study protocol, the laboratory reference range, and the sponsor's instructions before being used for any clinical decision, eligibility determination, or dosing action. The CRC Toolkit assumes no responsibility for clinical decisions made on the basis of calculator output.
Not Regulatory or Legal Advice
References to FDA regulations (21 CFR), ICH guidelines (E6, E8, and others), eCFR sections, EMA guidance, OHRP/HHS regulations, and other regulatory frameworks are drawn from publicly available primary sources. These references are provided for orientation and study. They are not legal, regulatory, or compliance advice. Regulations change. The version cited on a given page reflects the regulatory text in force at the time of publication or update. Always consult the current version of any regulation directly through the issuing authority (ecfr.gov, fda.gov, ich.org, ema.europa.eu) for the official, binding text. Sponsor-specific protocol requirements, IRB conditions, and institutional policies often impose additional or more restrictive standards than the regulatory minimum — your study documents always control.
No Professional Relationship
Reading content on this site, sending an email through the contact page, or interacting with any tool does not create an investigator-coordinator relationship, a consulting engagement, an attorney-client relationship, or any other professional or fiduciary relationship between you and The CRC Toolkit or its author. The site is an asynchronous educational resource. It is not a help desk, a regulatory consultancy, or a clinical decision-support service. For questions about your own study, your own participants, or your own employment situation, please consult the appropriate qualified professional (your principal investigator, sponsor medical monitor, IRB, study coordinator manager, professional society, or employment counsel as relevant).
No Submission of Protected Information
Do not send any Protected Health Information (PHI), participant identifiers, sponsor-confidential material, blinded study data, draft protocols, or other regulated or proprietary content to any email address associated with this site. The CRC Toolkit is not a HIPAA covered entity or business associate and is not equipped to receive, store, or process protected data of any kind. If your question requires reference to real study details, please describe the situation in general, non-identifying terms only. Any protected information received in error will be deleted without further use.
Independence and No Affiliation
The CRC Toolkit is not affiliated with, endorsed by, certified by, or sponsored by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the International Council for Harmonisation (ICH), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP), the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SOCRA), the Drug Information Association (DIA), or any contract research organization, pharmaceutical sponsor, academic medical center, or professional society. Where these organizations are named on this site, it is solely to reference their publicly available standards or guidance. The site does not receive funding, content direction, or editorial input from any of them.
External Links and Third-Party Resources
The CRC Toolkit links to external websites — most commonly to ecfr.gov for regulatory text, fda.gov for FDA guidance documents, ich.org for ICH guidelines, clinicaltrials.gov for study registry information, and the websites of professional societies. These links are provided as a service to readers. We do not control the content, availability, or accuracy of external sites and do not endorse their content beyond the specific citation referenced. External content may change after we link to it. Readers should verify any externally-sourced fact against the current source.
No Warranties; Use at Your Own Risk
All content on The CRC Toolkit is provided on an "as is" and "as available" basis, without warranty of any kind, express or implied. The author makes commercially reasonable efforts to ensure accuracy, currency, and clarity, but does not warrant that the content is free of errors, complete, current as of any specific date beyond the page's "Updated" date, or fit for any particular purpose. To the maximum extent permitted by applicable law, The CRC Toolkit and its author disclaim all liability for any loss, damage, regulatory finding, protocol deviation, employment consequence, clinical outcome, or other harm arising from reliance on any content published here. Your use of this site is at your own risk.
If you believe any specific content on this site is inaccurate, outdated, or otherwise problematic, please email ask@thecrctoolkit.com with the page URL and the specific issue. We review all corrections and update flagged content within two weeks.