GCP Basics - refresher
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1 p. 01 GCP Basics - refresher
2 Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues
3 Brief History of GCP 3
4 Brief History of GCP Declaration of Helsinki, written by the World Medical Association (WMA), an international organisation representing physicians. Incorporated the Nuremberg code Provided the highest ethical standards at that time
5 Brief History of GCP International Conference on Harmonisation (ICH), consisting of authorities of Europe, US and Japan and experts from pharmaceutical industries. Led to an international, uniform standard to accept the results of clinical trials, as long as they are conducted according to the ICH-GCP guidelines.
6 Brief History of GCP ICH GCP evolved from an economic incentive to a legal requirement in Europe Directive 2001/20/EC Commonly known as The Clinical Trials Directive Came into force in all European member states in May Directive 2005/28/EC Commonly known as The GCP Directive Came into force in all European member states in Jan 2006
7 Brief History of GCP Regulation 536/2014 The Clinical Trial Regulation Applies from May 28th 2016 (at the earliest*) Will be available by October 2018.(according to EMA homepage)
8 GCP Regulations 8
9 GCP Regulations 9 Regulations relating to GCP - US Electronic Records; Electronic Signatures (21 CFR Part 11) Protection of Human Subjects (Informed Consent) (21 CFR Part 50) Financial Disclosure by Clinical Investigators (21 CFR Part 54) Institutional Review Boards (21 CFR Part 56) Investigational New Drug Application (21 CFR Part 312) Foreign Clinical Trials not conducted under an IND (21 CFR Part ) Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator) Applications for FDA Approval to Market a New Drug (21 CFR Part 314) Bioavailability and Bioequivalence Requirements (21 CFR Part 320) Applications for FDA Approval of a Biologic License (21 CFR Part 601)
10 GCP Regulations 10 Regulations relating to GCP - EU Directive 2001/20/EC implementation of GCP in conduct of clinical trials on medicinal products for human use Directive 2005/28/EC detailed guidelines for GCP as regards IMP for human use Directive 2003/94/EC principles and guidelines of GMP in respect of medicinal products for human use and IMP for human use Regulation 536/2014 (not yet applicable)
11 GCP Regulations 11 Regulations relating to GCP - RoW..
12 Good Clinical Practice (GCP) 12 ICH E6 provides a unified standard for the European Union (EU), Japan, and the United States facilitates the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions applicable to drug and biological products
13 What does it mean? p. 013 The Code of Federal Regulation is law in US and non-compliance can in worst case be handled as a criminal offence In Europe the directives and associated GCP regulations have been (country specific) laws since 2004 In Japan GCP is law as stated in MHW Ministerial Ordinance No.28 (Mar.27,1997), No.106 (Jun.12, 2003), No.72 (Mar.31, 2006), No.24 (Feb.29, 2008) & No 161 (Dec 28, 2012)
14 ICH Guideline for GCP 14 Introduction states: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. and by inference, the converse is also true!
15 ICH Guideline for GCP 15 Table of Contents 1. Glossary 2. The Principles of ICH GCP 3. Institutional Review Board / Independent Ethics Committee 4. Investigator 5. Sponsor 6. Clinical Trial Protocol and Protocol Amendments 7. Investigator s Brochure 8. Essential Documents for the Conduct of a Clinical Trial
16 Good Clinical Practice 16 The principles of ICH GCP
17 The Principles of ICH GCP Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
18 The Principles of ICH GCP Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
19 The Principles of ICH GCP The rights, safety and well being of trial subjects shall prevail over the interests of science and society: Informed Consent Ethics Committees Records of Adverse Events
20 The Principles of ICH GCP The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial: Investigator s Brochure
21 The Principles of ICH GCP Clinical trials should be scientifically sound and described in a clear, detailed protocol: Input from external medical experts Input from internal medical experts and statisticians Reviewed and accepted by regulatory authorities
22 The Principles of ICH GCP A trial should be conducted in accordance with the protocol that has received prior institutional review board (IRB) / independent ethics committee (IEC) approval / favourable opinion: Regulatory Green Light
23 The Principles of ICH GCP The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist: Principal Investigator (PI) Sub-investigator
24 The Principles of ICH GCP Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective tasks: Maintain: Job description, CV, Training record. Perform: Activities in which you are trained and for which you have documentation.
25 The Principles of ICH GCP Freely given informed consent should be obtained from every subject prior to clinical trial participation. Information should contain details concerning Data Privacy and potential transfer of data outside EU
26 The Principles of ICH GCP All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification: ALCOACC Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent Maintenance of Trial and Site Master Files Archiving Validation
27 The Principles of ICH GCP The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements: Patient ID Numbers Data protection / HIPAA
28 The Principles of ICH GCP Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol: Technical Green Light QP release for European IMP
29 The Principles of ICH GCP Systems with procedures that assure the quality of every aspect of the trial should be implemented: Quality Control Monitoring Quality Assurance / Auditing And.. anything else that is necessary!
30 Good Clinical Practice 30 Sponsor Responsibilities
31 Sponsor QA and QC The Sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded) and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). Follow current versions of SOPs
32 Sponsor QA and QC Quality Control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
33 Sponsor Contract Research Organisation A sponsor may transfer any or all of the sponsor s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control. Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
34 Sponsor Trial Design The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.
35 Sponsor Trial Management etc. When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: Ensure and document that the system is validated Maintain SOPs for using these systems Ensure an audit trail is maintained Maintain a security system to prevent unauthorised access Maintain a list of individuals who are authorised to make data changes Maintain adequate backup of the data Safeguard the blinding.
36 Sponsor Trial Management etc. The Sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents pertaining to the trial. Trial Master File (8.1.) Any or all of the essential documents may be subject to, and should be available for, audit by the sponsor s auditor or inspection by the regulatory authorities. Maintain TMF up to date at all times
37 Sponsor 5.5.6, -Trial Master File 37 Keep your documents in control!
38 Sponsor Investigator Selection 38 The sponsor should obtain the investigator's agreement: to conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) and with the protocol agreed to by the sponsor and given approval/favourable opinion by the IRB/IEC and document that the system is validated to comply with procedures for data recording/reporting to permit monitoring, auditing and inspection and to retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed. The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.
39 Sponsor & Investigator FDA Form
40 Sponsor IMP: Manufacturing, Packaging, Labelling & Coding The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists, storage managers) of these determinations.
41 Sponsor IMP: Manufacturing, Packaging, Labelling & Coding In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
42 Sponsor IMP: Supplying and Handling The sponsor should: Ensure timely delivery of investigational product(s) to the investigator(s). Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for deficient product recall, reclaim after trial completion, expired product reclaim). Maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.
43 Sponsor Safety Information The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC s approval/favorable opinion to continue the trial.
44 Sponsor Monitoring The purposes of trial monitoring are to verify that: The rights and well-being of human subjects are protected The reported trial data are accurate, complete and verifiable from source documents The conduct of the trial is in compliance with the currently approved protocol/amendment, with GCP and with applicable regulatory requirements
45 Sponsor Monitoring The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. [ ]
46 Sponsor Monitoring Monitor s Responsibilities
47 Sponsor Noncompliance Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirements by an investigator or by members of the sponsor s staff should lead to prompt action by the sponsor to secure compliance.
48 Sponsor Noncompliance If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of the investigator/institution, the Sponsor should terminate the investigator/institution s participation in the trial, and promptly notify the regulatory authorities.
49 Sponsor Clinical Trial/Study Reports Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s).
50 Sponsor Clinical Trial/Study Reports The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)
51 Computer Systems 51
52 Computer Systems CFR part 11 electronic records; electronic signatures, 1997 Computerized Systems used in Clinical Investigations, FDA, 2007 Volume 10 of The rules governing medicinal products in the European Union, chapter IV, annex III computer systems, Eudralex 2008 Good practices for computerised systems in regulated "gxp" environments, PIC/S, 2007
53 Computer Systems CFR Part 11 Requires: procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.
54 Computer Systems CFR Part 11 Requires: Validation of Systems Protection of records Limiting access to authorised individuals Secure audit trails Education, training and experience Policies to hold individuals accountable Documentation controls
55 GCP Compliance Issues 55
56 GCP Compliance Issues 56 Procedures The necessary procedures to secure the quality of every aspect of the trials shall be complied with.
57 GCP Compliance Issues 57 Procedures Document Control: Version numbering and traceability Which version of the document was effective on this date? Archiving, retrieval and prevention of inadvertent use Can you provide me with the original, signed document in this version? Awareness and distribution Was the person conducting the activity following the effective version of the document on this date?
58 GCP Compliance Issues 58 Procedures Compliance Current, effective procedures shall be complied with. Procedures shall be maintained up-to-date. Build-in flexibility when writing procedures. Flexibility not ambiguity Document unavoidable non-compliance. (and avoid avoidable non-compliance!)
59 GCP Compliance Issues 59 Procedures Awareness Each person must be able to document contemporary awareness of procedures relevant to their job function. What is relevant?
60 GCP Compliance Issues 60 Training Shall be consistent with the person s job function. Shall be maintained up-to-date. Shall be documented. Shall be planned, especially in connection with internal transfers, promotions and extended absence.
61 Good Clinical Practice 61 Good Clinical Practice is a set of quality requirements for clinical trials that provides assurance that the rights, safety and well-being of patients are protected, and that the results of the clinical trials are credible.
62 Good Clinical Practice (GCP) 62
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