PCT Useful Links
Clinical trial Reporting Guidelines and Tools
- CONSORT – Consolidated Standards of Reporting Trials
- CONSORT – Pragmatic Trials Checklist
- CONSORT – Cluster Trials Checklist
Data Privacy and Protection
- GDPR – Regulation (EU) 2016/679 (General Data Protection Regulation)
- Guide to the General Data Protection Regulation (GDPR)
- Compilation of Guidances on the EU General Data Protection Regulation
- HIPAA – Health Insurance Portability and Accountability Act of 1996
- HIPAA – Privacy Rule
- HIPAA – Security Rule
- HIPAA – Breach Notification Rule
- HIPAA – Administrative Simplification [Unofficial Combined Regulatory Text]
- Covered Entities and Business Associates
- Covered Entity Decision Tool
- Fast Facts for Covered Entities
- Business Associates
- Business Associate Contracts
- Summary of the HIPAA Privacy Rule
- HIPAA for Professionals
- NIH Publication – Health Services Research and the HIPAA Privacy Rule
- NIH Publication – Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
- NIH Publication – Institutional Review Boards and the HIPAA Privacy Rule
- NIH Publication – Privacy Boards and the HIPAA Privacy Rule
eConsent and eSignatures
- FDA Guidance for Industry – Use of Electronic Informed Consent in Clinical Investigations: Questions an Answers – December 2016
- 21 CFR 11 – Electronic Reports; Electronic Signstures
- MHRA/ HRA Joint statement on seeking consent by electronic methods – September 2018
- Transcelerate eConsent Initiative
EU - Useful Links
- EMA – European Medicines Agency
- EMA – GCP Compliance
- EMA – National Competent Authorities
- EMA – Prime: Priority Medicines
- EMA – Reflection Paper on Electronic Source Data (2010)
- EMA – eSource Direct Data Capture (DDC) qualification opinion (Oct 2018)
- EudraLex – EU Legislation
- EudraLex Volume 1 – EU Pharmaceutical Legislation for Medicinal Products for Human Use
- EudraLex Volume 4 – Good Manufacturing Practice (GMP) Guidelines
- EudraLex Volume 10 – Clinical Trials Guidelines
- European Commission (EC) – Medicinal Products
- EC – Legal Framework Governing Medicinal Products for Human Use in the EU
- EC – Medicines for Children
- EC – Orphan Medicinal Products
- EC – Advanced Therapies
- EC – Clinical Trials
- EC – GMP and GDP
- EC – Pharmacovigilance
- EC – Personalised Medicines
- Clinical Trials Regulation – Regulation EU/536/2014
Global Guidelines - Ethical and Operational
Patient Reported Outcomes (PROs)
- FDA Presentation – Measuring How Patients Feel and Function – May 2017
- FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims – December 2009
- CDRH Report – Value and Use of Patient–Reported Outcomes (PROs) in Assessing Effects of Medical Devices:
Center for Devices and Radiological Health (CDRH) Strategic Priorities 2016 – 2017
- PCORI – Patient-Centered Outcomes Research Institute
- PCORTF – Patient-Centered Outcomes Research Trust Fund
- IPSOR – Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force – 2013
- PROMS – Patient Reported Outcomes Measures – UK NHS Digital
Pharmaceutical self-Regulatory Bodies
- EFPIA (EU) – European Federation of Pharmaceutical Industries and Associations
- EFPIA – Codes and Relationships
- EFPIA – National Codes
- PhRMA (USA) – Pharmaceutical Research and Manufacturers of America
- PhRMA – Code on Interactions With Health Care Professionals
- PhRMA – Principles on Conduct of Clinical Trials
Pragmatic Trial Design Tools
- imi GetReal – New methods for RWE collection and synthesis
- PragMagic – imi GetReal Pragmatic Trial Design Tool
- Real World Evidence (RWE) Navigator
- SureReal – The purpose of Sure-Real is to assess the impact of alternative evidence generation strategies in clinical drug development using real-world evidence.
- Drugis.org – Drug Information Systems
- ADDIS – Aggregate Data Drug Information System = an evidence-based decision support system for health care policy decision making that concerns alternative treatment options
- PRECIS – PRagmatic Explanatory Continuum Indicator Summary
Regulatory Use of Real World Evidence (RWE)
- FDA – Food and Drug Administration
- FDA Website – Real World Evidence
- Framework for FDA’s Real World Evidence Program – December 2018
- Sherman et. al, (2017). Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nature Reviews Drug Discovery volume 16, pages 297–298 (2017)
- A Framework for Regulatory Use of Real World Evidence. Center for Health Policy at Duke University – September 2017
- FDA Guidance – Use of Real–World Evidence to Support Regulatory Decision–Making for Medical Devices – August 2017
- FDA In Brief: FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making – November 2018
- FDA’s MyStudies Application (App) – November 2018
- EMA – European Medicines Agency
- EMA Discussion Paper – Use of Patient Disease Registries for Regulatory Purposes: Methodological and Operational Considerations – November 2018
UK - Useful links
- MHRA – Medicines and Healthcare products Regulatory Agency
- MHRA – Clinical Trials and Investigations
- HRA – Health Research Authority
- HRA – Standard Operating Procedures
- HRA – Guidance on Study Type
- NIHR – National Institute of Health Research
- NIHR – Study Support Service
- NIHR – Clinical Trials Tool Kit
- Clinical Trials Legislation
- Canary Ltd – UK Clinical Trial Regulations, Indexed and Consolidated (3rd Edition)
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SI 2004/1031: The Medicines for Human Use (Clinical Trials) Regulations 2004
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SI 2006/1928: The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
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SI 2006/2984: The Medicines for Human Use (Clinical Trials) Amendments (No.2) Regulations 2006
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SI 2008/941: The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008
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SI 2009/1164: The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009
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SI 2010/1882: The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010
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SI 2012/1916: The Human Medicines Regulations 2012
USA - Useful Links
- FDA – Food and Drug Administration
- FDA – Clinical Trials and Human Subject Protection
- FDA – Regulations Relating to Good Clinical Practice and Clinical Trials
- FDA – Drugs
- FDA – Develop and Approval Process (Drugs)
- eCRF – Electronic Code of Federal Regulations
- 21 CFR 11 – Electronic Reports; Electronic Signstures
- 21 CFR 50 – Protection of Human Subjects: Informed Consent
- 21 CFR 54 – Financial Disclosure by Clinical Investigators
- 21 CFR 56 – Institutional Review Boards
- 21 CFR 312 – Investigational New Drug Application
- 21 CFR 314 – Applications for FDA Approval to Market a New Drug
- HIPAA – Health Insurance Portability and Accountability Act of 1996
- HIPAA – Privacy Rule
- HIPAA – Security Rule
- HIPAA – Breach Notification Rule
- HIPAA – Administrative Simplification [Unofficial Combined Regulatory Text]
- Covered Entities and Business Associates
- Covered Entity Decision Tool
- Fast Facts for Covered Entities
- Business Associates
- Business Associate Contracts
- Summary of the HIPAA Privacy Rule
- HIPAA for Professionals
- NIH Publication – Health Services Research and the HIPAA Privacy Rule
- NIH Publication – Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
- NIH Publication – Institutional Review Boards and the HIPAA Privacy Rule
- NIH Publication – Privacy Boards and the HIPAA Privacy Rule