NIS Useful Links
Data Privacy and Data Protection - HIPAA and GDPR
- 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
Demonstrating Value with Real World Data - ABPI
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 - EMA, ENCePP, Eudralex and GDPR
- EMA – European Medicines Agency
- EMA – Guidance on Post-Authorisation Safety Studies (PASS)
- EMA – Good Pharmacovigilance Practices (GVPs)
- EMA – Guidance on Post-authorisation efficacy studies (PAES)
- ENCePP – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
- ENCePP – Guide on Methodological Standards in Pharmacoepidemiology
- ENCePP – Checklist for Study Protocols
- 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
- EudraLex – EU Legislation
- EudraLex Volume 1 – EU Pharmaceutical Legislation for Medicinal Products for Human Use
- Regulation EC/726/2004 (as amended)
- Regulation EU/520/2012 – Commission Implementing Regulation of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and the Council Directive 2001/83/EC of the European Parliament and of the Council
- Directive 2001/83/EC (Marketed Products Directive – as amended)
- Regulation EU/357/2014 (Supplementing Directive 2001/83/EC and Regulation (EC) No 726/2004 as Regards Situations in which Post-Authorisation Efficacy Studies May be Required)
- Regulation EU/1235/2010 (amending Regulation EC/726/2004)
- Directive 2010/84/EU (Pharmacovigilance Directive – amending 2001/83/EC)
EU - Post-Authorization Safety Studies (PASS)
- EMA – European Medicines Agency
- EMA – Guidance on Post-Authorisation Safety Studies (PASS)
- EMA – Pharmacovigilance Risk Assessment Committee (PRAC)
- EMA – Guidance for the Format and Content of the Protocol of Non-Interventional Post-Authorisation Safety Studies – September 2012
- EMA – Guidance for the Format and Content of the Final Study Report of Non-Interventional Post-Authorisation Safety Studies – July 2013
- EMA Good Pharmacovigilance Practices (GVPs)
- EMA GVP Module VIII – Post-Authorisation Safety Studies (PASS)
- EMA GVP Module VI – Collection, Management and Submission of Reports of Suspected Adverse Reactions to Medicinal Products
- EU PAS Register
- EU PAS Register Guide
- ENCePP Guide on Methodological Standards in Pharmacoepidemiology
- ENCePP Checklist for Study Protocols
- The EU Pharmacovigilance System
- Regulation EC/726/2004 (as amended)
- Regulation EU/520/2012 – Commission Implementing Regulation of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and the Council Directive 2001/83/EC of the European Parliament and of the Council
- 2001/83/EC (Marketed Products Directive – as amended)
- Regulation EU/357/2014 (Supplementing Directive 2001/83/EC and Regulation (EC) No 726/2004 as Regards Situations in which Post-Authorisation Efficacy Studies May be Required)
- Regulation EU/1235/2010 (amending Regulation EC/726/2004)
- 2010/84/EU (Pharmacovigilance Directive – amending 2001/83/EC)
Free CHCUK Resources
Ethical and Operational Guidelines - DoH, ISPE, CIOMS and ICH
- Declaration of Helsinki (1964, 1975, 1983, 1989, 1996, 2000, 2004, 2008, 2013)
- About the Declaration of Helsinki
- ICH E2E
- ICH E6 (ICH GCP – Revision 2)
- ISPE: Guidelines for Good Pharmacoepidemiology Practices (GPP) – 2015
- ISPE: Data Privacy, Medical Record Confidentiality, and Research in the Interest of Public Health – 1998
- ISPE:The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement for Pharmacoepidemiology (RECORD-PE) – 2018
- Registries for Evaluating Patient Outcomes: A User’s Guide – 4th Edition
- CIOMS International Ethical Guidelines for Epidemiological Studies, 2008
Observational Study Reporting Guidelines and Checklists - STROBE
- STROBE Observational Study Report Checklists (2007)
- STROBE checklist for cohort, case-control, and cross-sectional studies
(combined)
- download PDF/ Word - Checklist for cohort studies - download PDF/ Word
- Checklist for case-control studies – download PDF/ Word
- Checklist for cross-sectional studies - download PDF/ Word
- Draft STROBE checklist for conference abstracts – download PDF
- STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ,Poole C, Schlesselman JJ, Egger M; Epidemiology. 2007 Nov;18(6):805-35. PMID: 18049195
Patient Reported Outcomes (PROs) - FDA, PCORI, ISPOR and PROMS
- 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 - EFPI and PhRMA
- 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
Rare Diseases - FDA Guidance
Registry Quality Standards (for EU HTA Acceptance)
Regulatory Use of Real World Evidence (RWE) - EMA and FDA Guidance
- FDA – Food and Drug Administration
- FDA Website – Real World Evidence
- FDA’s Framework for Real World Evidence – 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
- FDA Guidance for Industry (Draft) – Rare Diseases: Natural History Studies for Drug Development, March 2019
- FDA Guidance for Industry (Draft) – Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics (May 2019)
- EMA – European Medicines Agency
- EMA Discussion Paper – Use of Patient Disease Registries for Regulatory Purposes: Methodological and Operational Considerations – November 2018
RWE Study Design
UK - HRA and NIHR
- HRA – Health Research Authority
- HRA Standard Operating Procedures
- HRA Guidance on Study Type
- NIHR – National Institute of Health Research
- NIHR – Study Support Service
- NHS Digital – Accessing Patient Information for Research
- CPRD – Clinical Practice Research Datalink