Good Clinical Practice Guidelines for lecture (18th March research cel

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Good Clinical Practice is the prerequisite for any clinical study. This topic is very important in current perspectives. The practice of good clinical practices also reduces the cost of clinical study as well as it also delivers credible data.

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Good Clinical Practice Guidelines:

Good Clinical Practice Guidelines Prof. R. K. Dixit Pharmacology and Therapeutics K.G.M.U. Lucknow

Declaration of Helsinki :

Declaration of Helsinki Medical progress based on research; improves treatments and understanding of disease but involves risks and burdens; must be subject to ethical standards Content of protocol Compliance with Declaration Independent REB must give continuing approval Well-being of subject overrides interests of science/ society Voluntary and informed participation Protect privacy and confidentiality of subjects Publication requirements Following famous cases such as the Nazis in WWII and black American men in syphilis studies (1932 –1972) there followed the declaration of Helsinki Good Clinical Practice – protects those in a trial, but also who’s treatment will depend on the data

What is Good Clinical Practice?:

What is Good Clinical Practice? Standards for the D esigning C onducting P erforming R ecording M onitoring A uditing A nalyzing R eporting O f C linical T rials

Definition of ICH-GCP :

Definition of ICH-GCP “ a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.” (ICH GCP)

Simply The GCP is……..:

Simply The GCP is…….. Data and Reported Results are Credible, and Accurate = Quality data Rights, Integrity, and Confidentiality of Trial Subjects are Protected = Ethics Quality Data + Ethics = GCP

PowerPoint Presentation:

What is an investigational product? ‘a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form’

PowerPoint Presentation:

Quality + Ethics

ICH-GCP:

ICH-GCP GCP: Basic Structure 1. Glossary 2. Principles 3. REB responsibilities 4. Investigator responsibilities 5. Sponsor responsibilities 6. Protocol and amendments 7. Investigator Brochure 8. Essential Documents

Prior to Opening Trial:

Prior to Opening Trial What regulations apply? Can your settings comply? Investigator qualifications, CV, conflicts, trial training Prepare ethics and regulatory binders Submit protocol Ensure GCP, compliance Informed consent – include all required elements and risks Initial full board ethical approval – submit all required information/documents

During the Trial:

During the Trial Informed consent prior to trial specific procedures Comply with the protocol, document/report Source documents Maintain essential documents (GCP) Maintain confidentiality Ensure drug compliance Ongoing annual / Six monthly approval Ethical approval for amendments/changes

End of the Trial:

End of the Trial Inform Ethics Committee and others when trial closes Submit Final report Monitor long term safety : inform patients and Ethics committee as needed Retain records (included source documents and radiology) according to regulations Audits/inspections may occur during trial or after final analysis

Clinical Trials - Phases:

Clinical Trials - Phases 1-5 yrs Thousand - Lakhs Subjects with indications Post-marketing surveillance New indications, QoL , surveillance IV 2-3 yrs Hundreds-thousands Subjects with indications Safety & efficacy Basis for labeling, new formulations III 1-2 yrs Several hundred Subjects with indications Short-term side effects & efficacy II 6-12 mos 20-80 Healthy volunteers or subj. w/ indications Safety, ADME, bioactivity, drug-drug interaction I Length (per phase) Scope Subjects Purpose Phase

GOOD CLINICAL PRACTICE (GCP) BASICS:

GOOD CLINICAL PRACTICE (GCP) BASICS Study is well-designed and follows scientific principles IRB approval is required to insure rights and safety of subjects Informed consent freely given Sponsor/institution monitors study for GCP compliance Investigator accountable for all drugs/devices Records must be kept properly Data must be complete and accurate Quality assurance plans must be in place 21

IRB/EC Roles & Responsibilities:

IRB/EC Roles & Responsibilities To safeguard study subjects’ rights & welfare by: Evaluation/disposition of study proposal Evaluation of proposed subject consent materials Evaluation of emergency use consent methodology Evaluation of investigator qualifications Ongoing review of study progress (at least yearly) Evaluation of proposed subject compensation plans

Investigator Roles & Responsibilities:

Investigator Roles & Responsibilities Qualified to conduct study Have adequate resources to conduct study Provide medical care to study subjects Regular communication with IRB/EC reviewing study Compliance with study protocol Maintenance of investigational product accountability Compliance with study randomization & unmasking procedures Provide informed consent to study subjects

Sponsor Roles & Responsibilities:

Sponsor Roles & Responsibilities Study quality assurance Appropriately qualified medical personnel to advise on study Utilization of qualified personnel in study design & operations Study management, data handling & record keeping Investigator selection & training Definition/allocation of study responsibilities

Informed Consent Document Components:

Informed Consent Document Components Statement that study involves “research” & product “experimental” (if applicable) Study purpose Number of expected study subjects to be enrolled Study treatment(s) & probability for random assignment Study exams & procedures for duration of trial Subject’s responsibilities Foreseeable risks to subject (embryo, fetus, nursing infant)

From Where Can I Find These Documents?:

From Where Can I Find These Documents ? www.ich.org/cache/compo/276-254-1.html www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm www.gpoaccess.gov and www.regsource.com www.ich.org and www.fda.gov and www.nih.gov

Summary:

Summary ALL clinical research should take place within the Research Governance Framework ICH-GCP is core knowledge for critical care clinicians and essential for those involved in research Clinicians involved in research must have a good understanding of the principles of informed consent and study documentation.

ICH GCP Guidelines cover…:

ICH GCP Guidelines cover… Ethics Committee /IRB Essential Documents for conduct of a trial Clinical Trial Protocol & Amendments Investigator’s Brochure Sponsor Investigator

Thanks:

Thanks

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