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 Data handling in withdrawn cases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