ICH GCP

GOOD CLINICAL PRACTICES E6

Assignment ICH-GCP, Karan Mehta

ICH-GCP What It Is ?
An international ethical & scientific quality standard for designing, conducting, recording & reporting human clinical studies

EU Japan US

Applies to registration studies that may have an impact on safety & welfare of human subjects Objective: Unified standard and Mutual acceptance.

Assignment ICH-GCP, Karan Mehta

Principles
Acc to DOH, GCP & RA Benefit / Risk ratio Rights and Safety of trial subjects Documentation Support of nonclinical and clinical information Privacy and Confidentiality Scientifically sound; Protocol Compliance with IRB/EC approved protocol Responsibility of medical professional IND- GMP and Protocol Quality assurance Qualified by education, training & experience Freely given informed consent

Assignment ICH-GCP, Karan Mehta

IRB/IEC Roles & Responsibilities Reviews

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
Assignment ICH-GCP, Karan Mehta

Investigator Brochure Study protocol & amendments Investigator qualifications Informed consent documents, including subject recruiting tools Other written information provided to subjects Subject compensation plans Adverse events Protocol deviations

IRB/IEC Composition, Functions & Operations

Members have qualifications & experience to evaluate science, medical aspects & ethics of proposed study

5 members 1 member whose primary interest in nonscientific 1 member independent of institution or study site

Written SOPs & records Decisions rendered at announced meetings with quorum in attendance Only members participating in review should vote Investigator may provide info on study, but should not be involved in review or vote Nonmembers with expertise in special areas may be invited to assist with review (but cannot vote) Assignment ICH-GCP, Karan Mehta

IRB/IEC Procedures
Document group membership & qualifications Schedule meetings & notify members Conduct initial & ongoing review of studies Determine ongoing review frequency Provide expedited review of minor study changes, in accordance with regulatory requirements Specify that no subject should be enrolled in study prior to IRB/EC approval Specify that no deviations from protocol should be initiated without prior IRB/EC approval Specify that Investigator should promptly report: Protocol deviations,Changes increasing subject risk or study procedures, Serious and unexpected adverse events. Notify Investigator promptly of its decisions
Assignment ICH-GCP, Karan Mehta

IRB/IEC Required Records

Relevant records maintained 3 yr after study completion Records available for review by regulatory authorities

Assignment ICH-GCP, Karan Mehta

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

Compliance with study protocol

Assignment ICH-GCP, Karan Mehta

Investigator Appropriate Qualifications

Training & experience demonstrated via: Medical license CV Specialized study training GCP training If study responsibilities delegated, need a list of qualified persons to whom responsibilities are delegated

Assignment ICH-GCP, Karan Mehta

Investigator
Adequate Resources Potential for recruiting patients Sufficient time Adequate no. of staff and facilities Duties properly delegated and explained IRB/IEC Communications IRB/IEC approval prior to study initiation IRB/IEC kept apprised of events & progress during study
Assignment ICH-GCP, Karan Mehta

Medical Care Make medical decisions regarding patient treatment Adequate care for study-related adverse events Inform patients physician Try to ascertain reason(s) for subject withdrawals from study

Investigator
Protocol Compliance
Conduct study in accordance with protocol May not deviate from protocol without Sponsor/IRB approval Document deviations from protocol

Investigational Product(s)
Maintain accountability at study site Document product receipt & disposition Maintain product in a secure area Use product only in accordance with protocol Disallow use of product by anyone not registered with study

Assignment ICH-GCP, Karan Mehta

Investigator Responsibilities Randomization Procedures & Unblinding

Follow study randomization procedures Unblind only in accordance with protocol Document noncompliance or premature unblinding

Assignment ICH-GCP, Karan Mehta

Investigator Informed Consent

Comply with regulatory requirements Update consent documents as necessary Inform subject that study involves investigational product May not coerce subject to participate May not waive subjects legal rights Keep subject informed of new information regarding study
Provide informed consent in understandable language Give subject the chance to ask questions If subject cant read, need impartial witness If subject is disadvantaged, need legally authorized witness Get subject consent in writing prior to initiation of study procedures Give subject a copy of signed consent document

Assignment ICH-GCP, Karan Mehta

Investigator Records & Reports

Source documentation Case record forms (study-specific) Changes/corrections in CRF Fully executed informed consent documents Essential documentation as per section 8 of ICH GCP E6 Written periodic status reports to IRB/EC Written reports of protocol deviations to Sponsor & IRB/EC Serious or unanticipated product-related adverse events to Sponsor & IRB/EC Notification of study suspension or termination to IRB/EC Final study report to IRB/EC Retain 2 yr
Assignment ICH-GCP, Karan Mehta

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 Facilitation of communications between Investigators Study compensation (investigators and/or subjects) & financing Regulatory authority notification/submission Sponsor may transfer responsibilities to CRO

Transfer must be documented in writing Sponsor still has ultimate responsibility for study quality and data integrity

Assignment ICH-GCP, Karan Mehta

Sponsor Roles & Responsibilities

Confirmation of IRB/EC review/approval Investigational product information Investigational product manufacturing, packaging, labeling & coding Investigational product supply & handling Record access Ongoing safety evaluation & reporting Serious/unanticipated adverse event reporting Study monitoring Study noncompliance procedures Study termination or suspension notification Study reports
Assignment ICH-GCP, Karan Mehta

Study Protocol Components

General administrative info Background Study purpose & objectives Study design Subject eligibility requirements How subjects will be treated How safety & efficacy will be assessed Sample size justification & statistical analysis methods How data will be captured & maintained Monitoring procedures Proposed informed consent document

Assignment ICH-GCP, Karan Mehta

Investigator Brochure What Is It ?

A compilation of clinical & non-clinical data on the product that is relevant to the products study in human Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale

Assignment ICH-GCP, Karan Mehta

Investigator Brochure Components

Product formulation summary Introduction/background info regarding product & investigational plan Investigational product physical, chemical & pharmaceutical properties & formulation Non-clinical studies Human clinical studies Summary of data & guidance for Investigator

Assignment ICH-GCP, Karan Mehta

Essential Documents
Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. 3 sections: 1. Before the clinical Phase 2. During the clinical Phase 3. After completion of trial

Assignment ICH-GCP, Karan Mehta

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