Clinical Trial Documents
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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. 2. 3. 4. 5. 6.
General information Background information Trial objectives and Purpose Trial design Selection and withdrawal of subjects Treatment of subjects
Contents of the Clinical trial Protocol (Section6 ICH-GCP 1. 2. 3. 4. 5.
Assesment of efficacy Assesment of safety Statistics Direct access to the source documents 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Subject inclusion criteria Subject exclusion criteria When and how to withdraw Replacement Data handling in withdrawn cases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
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. 2. 3. 4. 5. 6.
General information Background information Trial objectives and Purpose Trial design Selection and withdrawal of subjects Treatment of subjects
Contents of the Clinical trial Protocol (Section6 ICH-GCP 1. 2. 3. 4. 5.
Assesment of efficacy Assesment of safety Statistics Direct access to the source documents 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
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