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Data handling in withdrawn cases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
