Clinical Trials: ICH, GCP rules, regulatory (EMEA, FDA) GCP inspections. Key documents.

GCP training on-line (GCP certification)

1) GCP course for Investigators and CRAs

2) GCP course for Auditors

(see below or for detailed information click here)

GCP training curriculum

(1) GCP training for Beginners

ICH-GCP (E6-R2) international guidelines

1: Introduction to GCP
1.1 Background
1.2 What is GCP?
1.3 New GCP Guide 2019
1.4 The Principles of ICH GCP – 2019
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Quality Assurance

2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records

3: Investigator

3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 Records and Reports I
3.11 Premature Termination or Suspension of a Trial
3.12 Progress Reports and Final Report(s) by Investigator
3.13 Archiving
3.14 Considerations for the use of electronic systems in clinical trial management
3.15 Updated information on electronic records and use of EMRs in clinical research.В

4: Sponsor’s Responsibilities

4.1 Quality Assurance and Quality Control
4.2 Contract Research Organizations
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 Manufacturing, Packaging, Labelling and Coding Investigational Products
4.12 Supplying and Handling Investigational Products
4.13 Record Access
4.14 Audit and Inspection
4.15 Noncompliance
4.16 Premature Termination or Suspension of a Trial
4.17 Clinical Trial/Study Reports
4.18 Multicentre Trials

5: Monitor’s Responsibilities

5.1 About this Chapter
5.2 Introduction
5.3 Monitoring I

6: Safety & Adverse Event Reporting

6.1 Adverse Drug Reaction Reporting

7: Clinical Trial Protocol and Amendments

7.1 Trial Objectives and Purpose
7.2 Trial Design
7.3 Selection and Withdrawal of Subjects
7.4 Treatment of Subjects
7.5 Assessment of Efficacy
7.6 Assessment of Safety
7.7 Statistics
7.8 Direct Access to Source Data/Documents
7.9 Ethics
7.10 Financing and Insurance
7.11 Publication Policy

8: Investigator Brochure

9: Essential Documents

9.1 Archiving
9.2 Documents to be Present Pre-Study
9.3 Documents to be Added During the Study
9.4 Documents to be Added Post-Study

10 Examples

10.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials

ICH-GCP (E6-R2) international guidelines

(2) Advanced GCP training

1: Introduction to GCP
1.1 Background
1.2 What is GCP?
1.3 New GCP Guide
1.4 The Principles of ICH GCP
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Quality Assurance

2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records
2.5 How to avoid Ethics Committee issues;
2.6. How to minimize safety issues;
2.7. Measures to protect confidentiality of clinical trial subjects;
2.8 Revisions and updates to the section on HIPAA and privacy.В В

3: Investigator

3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 The best practices in obtaining informed consent;
3.11 How to assess good oversight by a Principal Investigator;
3.12 Records and Reports I
3.13 Premature Termination or Suspension of a Trial
3.14 Progress Reports and Final Report(s) by Investigator
3.15 Archiving
3.16 В Considerations for the use of electronic systems in clinical trial management
3.17 Updated information on electronic records and use of EMRs in clinical research.В

4: Sponsor’s Responsibilities

4.1 Quality Assurance and Quality Control
4.2 Contract Research Organizations
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 What clinical trial processes should be covered by SOPs;

4.12 The impact and principles of good vendor oversight;

4.13 Optimal management of IMP;

4.14 How to avoid Ethics Committee issues;

4.15 Ensuring data quality by enhancing data management systems.

4.16 Manufacturing, Packaging, Labelling and Coding Investigational Products

4.17 Supplying and Handling Investigational Products

4.18 Record Access
4.19 Audit and Inspection
4.20 Noncompliance
4.21 Premature Termination or Suspension of a Trial
4.22 Clinical Trial/Study Reports

4.23 Multicentre Trials

5: Monitor’s Responsibilities

5.1 About this Chapter

5.2 Introduction

5.3 Monitoring I

5.4 Understand current thinking on risk based monitoring approaches and develop appropriate monitoring strategies for your study

5.5. Develop superior strategies for selecting sites, recruiting patients and motivating investigational sites

5.6. Significantly improve your performance as a monitor to an advanced level

5.7. Use effective planning and tracking tools to maximize efficiency as a monitor

5.8. Develop strategies for dealing with complex monitoring issues

5.9.Gain expertise in monitoring oversight activities

6: Safety & Adverse Event Reporting

6.1 Adverse Drug Reaction Reporting

7: Clinical Trial Protocol and Amendments

7.1 Trial Objectives and Purpose

7.2 Trial Design

7.3 Selection and Withdrawal of Subjects

7.4 Treatment of Subjects

7.5 Assessment of Efficacy

7.6 Assessment of Safety

7.7 Statistics

7.8 Direct Access to Source Data/Documents

7.9 Ethics

7.10 Financing and Insurance

7.11 Publication Policy

8: Investigator Brochure

9: Essential Documents

9.1 Archiving

9.2В В Documents to be Present Pre-Study

9.3 Documents to be Added During the Study

9.4 Documents to be Added Post-Study

10. GCP audits and inspections;

10.1The difference between audits and inspections;

10.2 The types of inspections at a sponsor or CRO or investigational site;

10.3 How best to prepare for an inspection;

10.4 Best practice for conduct during an inspection;

10.5 Common inspection findings and how to prevent their occurrence;

10.6 How to respond to inspection findings;

10.7 Construction of a plan for corrective and preventative actions.

10.8 The most common findings in Health Authority GCP inspections;

10.9 Review the regulations and guidance that governs clinical research compliance

10.10 Discuss GCP Auditing as a profession and how it differs from monitoring

10.11 Determine who gets audited and key factors and metrics for assessing when or why to audit

10.12 Explore how the FDA,EMEA,MHRA and local RB trains its inspectors to audit Clinical Investigators (Sites), Sponsors, and В Institutional Review Boards (IRBs)

10.13 Apply a quality-systems framework for assessing data and systems

10.14 Implement data trend analysis to identify regulatory risks

10.15 Develop practical auditing skills using real-life audit examples

10.16 Participate in role-play to enhance communication proficiency (Intake and Output)

10.17 Communicate comprehensive findings with writing exercises and group discussions

11 Examples

11.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials

12. Pharmacovigilance for Clinical Trials

A training package has been developed on the basis of the documents developed by ICH Steering Committee Members. We wish to thank to:

Dr. Peter Arlett
Head of Sector for Pharmacovigilance and Risk Management
European Medicines Agency London UK

Dr. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, Sweden

Dr. Christine-Lise Julou
European Federation of Pharmaceutical
Industries Associations – EFPIA Brussels, Belgium

Dr. AndrР№ W. Broekmans
Schering Plough Research Institute The Netherlands

Mr. Shinobu Uzu
Ministry of Health, Labour & Welfare Tokyo, Japan

Dr. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, Japan

Mr. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
Association – JPMA Tokyo, Japan Mr. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, Japan

Dr. Justina A. Molzon
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration Rockville, MD, USA

Dr. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, MD, USA

Dr. Alice Till
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of America – PhRMA
Washington DC, USA

Dr. Peter K. Honig
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories North Wales, PA, USA

Mme Alicia D. Greenidge
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

Mr. Mike Ward
International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch Health Canada

Dr. Lembit Rago
Quality Assurance and Safety : Medicines
HTP/EDM/QSM
World Health Organization Geneva, Switzerland

Dr. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, Switzerland

1) GCP course for Investigators and CRAs

Trainers for Eastern European countries:

Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP

Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
, GersonВ Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau,head of the Department of Clinical Research of NBScience, Zintro Inc. (USA )

Accreditation

International accreditation has been requested from:
HSC-Germany ,NBScience

GCP certification

GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience’s certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam.

Program:

“Main principles of Good Clinical Practice (GCP).

Regulatory acts of the European Union and International Conference of Harmonization (ICH).

Responsibilities and the rights of the parties participating in clinical trials.

Interaction of Sponsor and Investigator.

Responsibilities of Investigator, Sponsor according to principles of Good Clinical Practice (GCP)

“Ethical aspects of clinical trials of medical products.

Informed consent .

File of Investigator; keeping of documentation.

Legal and regulatory base of clinical trials of medical products in Europe.

FDA and EMEA.

The basic requests to the documentation for clinical trials of medical products.
Regulatory inspections of FDA and SPhC.

Types of inspections.

Responsibilities of Sponsor, Investigator and Inspector at the time of audits.

“Specific clinical trials and GCP regulations in your country”

Testing. GCP certification.

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2) On-line training course on GCP audit and inspection

(for detailed information click here)

Overview :

This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as advanced auditing, have become a basic task of many audit groups and are an essential element of inspections in Europe.

The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.