The document summarizes the key components of clinical trial protocol, case report form (CRF), and investigator's brochure (IB) as outlined by ICH-GCP guidelines. The protocol describes the objectives, design, methodology, statistics, and organization of a clinical trial. It includes sections on background, objectives, design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, statistics, and ethics. The CRF is used to record subject data during the trial. The IB provides clinical and non-clinical information on the investigational product being studied, including physical/chemical properties, non-clinical studies, toxicology, effects in humans, and guidance for investigators.
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The document summarizes the key components of clinical trial protocol, case report form (CRF), and investigator's brochure (IB) as outlined by ICH-GCP guidelines. The protocol describes the objectives, design, methodology, statistics, and organization of a clinical trial. It includes sections on background, objectives, design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, statistics, and ethics. The CRF is used to record subject data during the trial. The IB provides clinical and non-clinical information on the investigational product being studied, including physical/chemical properties, non-clinical studies, toxicology, effects in humans, and guidance for investigators.
The document summarizes the key components of clinical trial protocol, case report form (CRF), and investigator's brochure (IB) as outlined by ICH-GCP guidelines. The protocol describes the objectives, design, methodology, statistics, and organization of a clinical trial. It includes sections on background, objectives, design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, statistics, and ethics. The CRF is used to record subject data during the trial. The IB provides clinical and non-clinical information on the investigational product being studied, including physical/chemical properties, non-clinical studies, toxicology, effects in humans, and guidance for investigators.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online from Scribd
The document summarizes the key components of clinical trial protocol, case report form (CRF), and investigator's brochure (IB) as outlined by ICH-GCP guidelines. The protocol describes the objectives, design, methodology, statistics, and organization of a clinical trial. It includes sections on background, objectives, design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, statistics, and ethics. The CRF is used to record subject data during the trial. The IB provides clinical and non-clinical information on the investigational product being studied, including physical/chemical properties, non-clinical studies, toxicology, effects in humans, and guidance for investigators.
Copyright:
Attribution Non-Commercial (BY-NC)
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Download as PPT, PDF, TXT or read online from Scribd
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Clinical trial
documents:Protocol,CRF & IB
Dr.Pratibha Nadig M.D. ICRI Bagalore The Protocol The document that describes the objectives,design,methodology ,statistical considerations and organisation of a trial.
ICH-GCP1.44 Contents of the Clinical trial Protocol (Section6 ICH-GCP) 1. General information 2. Background information 3. Trial objectives and Purpose 4. Trial design 5. Selection and withdrawal of subjects 6. Treatment of subjects Contents of the Clinical trial Protocol (Section6 ICH-GCP 1. Assesment of efficacy 2. Assesment of safety 3. Statistics 4. Direct access to the source documents 5. Quality control and quality assurance procedures Contents of the Clinical trial Protocol (Section6 ICH-GCP 12.Ethics 13.Data handling and record keeping 14.Financing and insurance 15.Publication policy 16.Supplements General information Protocol title identifying number and date
Name and address of
1.the sponsor and monitor 2.persons authorized to sign the protocol General information
Name,addresses,title and telephone
numbers of 1.Sponsors’medical expert or dentist
2.INVESTIGATOR
3.Qualified physician who is responsible
for all trial-site related medical decisions. General information Name and addresses of Laboratories and any other institutions involved in the trial Background About the investigational product,
Studies done so far,rationale for the study
,literature review etc. Trial objectives and purpose Primary
secondary Trial design End points Type of the trial Randomization Blinding Treatment duration Dosage, route of administration Trial design Criteria for discontinuation of the trial
Identification of the data to be recorded
directly on the CRF Selection and withdrawal of the patients Subject inclusion criteria Subject exclusion criteria When and how to withdraw Replacement Data handling in withdrawn cases Treatment of the subjects The treatment given dose,duration,schedule,route of administration Rescue medication if any Procedures for monitoring patient compliance Assesment of efficacy Specification of the parameters
Methods of measuring,timing Recording,analysing, Assesment of safety Specification Methods of measuring,timing Recording,analyzing, Procedures to elicit reports of and recording,reporting of SAE, Follow up after adverse effects Statistics No.of subjects to be enrolled.
Type of statistical test to be applied
Level of significance acceptable
Direct access to the source or data documents Monitor Audits Regulatory IRB/IEC Quality control and quality assurance procedures Ethics Approvals,Amendments,by IRB/IEC Data handling and record keeping Mode of recording
Storage
Archiving etc. Financing and insurance In the event of adverse events
Insurance statements on compensations
to the participants of trial related injury Publication policy Rights of publication,
Authorship and co-authorship etc.
Supplements INVESTIGATORS BROCHURE Definition A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of the investigational product In the human subjects CONTENTS Summary
Introduction
Physical,chemical, pharmaceutical properties and the formulation CONTENTS Non clinical studies PK & PD
Toxicology
Effects in humans CONTENTS Summary of data guidance for the investigator
References Publications and reports
SUMMARY Brief summary not exceeding 2-3 pages.
All aspects of the contents described.
Introduction Chemical name Generic name Pharmacological class Rationale for the research Anticipated Prophylactic or therapeutic response Physical,chemical, and Pharmaceutical properties and formulation Chemical/structural formulae,
Description of the excepients
Storage and handling
Non clinical studies Detailed information on all the studies conducted including
Species,Number and sex,Dose,
Route of administration etc
Pharmacodynamic and kinetic studies
Toxicology studies (animals) Single dose Repeated dose Carcinogenecity Reproductive toxicity Genotoxicity Effects in humans Pharmacokinetics Product metabolism Safety and efficacy Marketing experience Summary of data and guidance to the investigators Comprehensive information to give a clear understanding of the possible risks and the effects Thank you
