From d77fa22e84ab63bba1ddfcd16572c810cb7e0ab8 Mon Sep 17 00:00:00 2001 From: z8 <1234yamd@gmail.com> Date: Fri, 16 Jan 2026 16:25:39 +0200 Subject: [PATCH] Security: Update HTTP URLs to HTTPS in FDA Clinical Protocol Template Updated all insecure HTTP URLs to HTTPS for FDA, HHS, and eCFR regulatory links to follow security best practices. This ensures all regulatory documentation references use encrypted connections. Changes: - Updated 13+ FDA links from http:// to https:// - Updated 8+ HHS/OHRP links from http:// to https:// - Updated 3 eCFR links from http:// to https:// Co-Authored-By: Claude Sonnet 4.5 --- .../assets/FDA-Clinical-Protocol-Template.md | 50 +++++++++---------- 1 file changed, 25 insertions(+), 25 deletions(-) diff --git a/clinical-trial-protocol-skill/assets/FDA-Clinical-Protocol-Template.md b/clinical-trial-protocol-skill/assets/FDA-Clinical-Protocol-Template.md index 8864aab..6a5b93b 100644 --- a/clinical-trial-protocol-skill/assets/FDA-Clinical-Protocol-Template.md +++ b/clinical-trial-protocol-skill/assets/FDA-Clinical-Protocol-Template.md @@ -41,46 +41,46 @@ Code of Federal Regulations (CFR) - [21 CFR Part 56: Institutional Review Boards](https://www.ecfr.gov/cgi-bin/text-idx?SID=64724709940d94a34270c77fdb8d307f&mc=true&node=pt21.1.56&rgn=div5) -- [21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies](http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.1.58&rgn=div5) +- [21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies](https://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.1.58&rgn=div5) -- [21 CFR Part 210: Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General](http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.210&rgn=div5) +- [21 CFR Part 210: Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General](https://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.210&rgn=div5) -- [21 CFR Part 211: Current Good Manufacturing Practice For Finished Pharmaceuticals](http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.211&rgn=div5) +- [21 CFR Part 211: Current Good Manufacturing Practice For Finished Pharmaceuticals](https://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.211&rgn=div5) - [21 CFR Part 312: Investigational New Drug Application](https://www.ecfr.gov/cgi-bin/text-idx?SID=27a0c0825d11663283856731fb14c8d2&mc=true&node=pt21.5.312&rgn=div5) - [21 CFR Part 812: Investigational Device Exemptions](https://www.ecfr.gov/cgi-bin/text-idx?SID=0f8fa3b740966b3d21d5501233e2b493&mc=true&node=pt21.8.812&rgn=div5) - [42 CFR Part 11: Clinical Trial Registration and Results Information Submission](https://www.gpo.gov/fdsys/pkg/CFR-2016-title42-vol1/pdf/CFR-2016-title42-vol1-part11.pdf) -- [45 CFR Part 46: Protection of Human Subjects Research](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) +- [45 CFR Part 46: Protection of Human Subjects Research](https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) Food and Drug Administration (FDA) -- [Compliance Actions and Activities](http://www.fda.gov/ICECI/EnforcementActions/default.htm) +- [Compliance Actions and Activities](https://www.fda.gov/ICECI/EnforcementActions/default.htm) -- [FDA Regulations Relating to Good Clinical Practice and Clinical Trials](http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm) +- [FDA Regulations Relating to Good Clinical Practice and Clinical Trials](https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm) -- [Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs -- Improving Human Subject Protection](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf) +- [Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs -- Improving Human Subject Protection](https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf) -- [Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf) +- [Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees](https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf) - [Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance](https://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf) -- [Guidance for Industry: Electronic Source Data in Clinical Investigations](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf) +- [Guidance for Industry: Electronic Source Data in Clinical Investigations](https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf) - [Guidance for Industry: Multiple Endpoints in Clinical Trials](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536750.pdf) -- [Guidance for Industry: Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring](http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf) +- [Guidance for Industry: Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring](https://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf) -- [Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf) +- [Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf) -- [Guidance for Industry: Providing Regulatory Submissions in Electronic Format --- Standardized Study Data](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf) +- [Guidance for Industry: Providing Regulatory Submissions in Electronic Format --- Standardized Study Data](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf) -- [Guidance for Industry: Safety Assessment for IND Safety Reporting](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm477584.pdf) +- [Guidance for Industry: Safety Assessment for IND Safety Reporting](https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm477584.pdf) Department of Health and Human Services (HHS) -- [The HIPAA Privacy Rule](http://www.hhs.gov/hipaa/for-professionals/privacy/) +- [The HIPAA Privacy Rule](https://www.hhs.gov/hipaa/for-professionals/privacy/) [HIPAA Privacy Rule: Information for Researchers](https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html) @@ -88,12 +88,12 @@ Department of Health and Human Services (HHS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) -- [Guidance for Industry, E6 (R2) Good Clinical Practice: Consolidated Guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464506.pdf) -- [Guidance for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073246.pdf) +- [Guidance for Industry, E6 (R2) Good Clinical Practice: Consolidated Guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464506.pdf) +- [Guidance for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals](https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073246.pdf) -- [Guideline for Industry, E3 Structure and Content of Clinical Reports](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073113.pdf) +- [Guideline for Industry, E3 Structure and Content of Clinical Reports](https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073113.pdf) -- [Guidance for Industry, E9 Statistical Principles for Clinical Trials](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf) +- [Guidance for Industry, E9 Statistical Principles for Clinical Trials](https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf) - [Final Concept Paper E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials](http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9__R1__Final_Concept_Paper_October_23_2014.pdf) @@ -131,19 +131,19 @@ National Institutes of Health (NIH) Office for Human Research Protections (OHRP) -- [Human Subject Regulations Decision Charts](http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html) +- [Human Subject Regulations Decision Charts](https://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html) -- [Informed Consent Checklist](http://www.hhs.gov/ohrp/policy/consentckls.html) +- [Informed Consent Checklist](https://www.hhs.gov/ohrp/policy/consentckls.html) -- [Informed Consent Tips](http://www.hhs.gov/ohrp/policy/ictips.html) +- [Informed Consent Tips](https://www.hhs.gov/ohrp/policy/ictips.html) -- [IRBs and Assurances](http://www.hhs.gov/ohrp/assurances/) +- [IRBs and Assurances](https://www.hhs.gov/ohrp/assurances/) -- [Regulations & Policy Index](http://www.hhs.gov/ohrp/regulations-and-policy/index.html) +- [Regulations & Policy Index](https://www.hhs.gov/ohrp/regulations-and-policy/index.html) -- [Unanticipated Problems Involving Risks and Adverse Events Guidance](http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html) +- [Unanticipated Problems Involving Risks and Adverse Events Guidance](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html) -- [Vulnerable Populations](http://www.hhs.gov/ohrp/regulations-and-policy/guidance/vulnerable-populations/) +- [Vulnerable Populations](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/vulnerable-populations/) Other