This document summarizes the key components of a clinical trial protocol. It discusses the types of clinical trials, phases of clinical trials, and the typical sections included in a protocol such as the title, objectives, study design, study population criteria, safety and efficacy assessments, statistics, and quality control plans. Protocols provide a formal design and plan for how a clinical trial will be conducted, managed, and reported.

1. Preparation of Protocol
Rushikesh S Tidake
M.Pharm Sem ll
Pharmacology
Rajarshi Shahu College of Pharmacy
Buldana
1/18

2. Contents
Introduction
Types of Clinical trial
Phases of Clinical trial
Clinical trial Protocols
2/18

3. Introduction
•Clinical trials are sets of tests in medical research & Drug
Development that generate safety and efficacy data for health
intervention (Eg. drugs,diagonistics,devices,therapy protocols)
•They are conducted only after satisfactory information has been
gathered on the quality of nonclinical safety ,and health
authority/ethics committee approval is granted in the country where
approval of the drug or device is sought.
•The clinical trial design & objectives are written into a document
called a clinical trial protocol. It is a document that states
background , objectives , rationale , design , methodology and
statistical consideration of the study .It also states the condition
under which the study shall be performed and managed .
3/18

4. Types of Clinical trial :
1) Prevention trial :
• Look for better ways to prevent disease in people who have
never had the disease or to prevent a disease from returning
.This approaches may include medicines vitamins , minerals , or
lifestyle changes .
2) Screening trial :
Test the best way to detect certain disease or health conditions.
• Assess the safety and effectiveness of a different dose of a
medication than is commonly used ( eg. 10mg dose instead of
5mg dose )
• Compare the effectiveness with patients with a specific disease
of two or more already approved or common interventions for
that disease .
4/18

5. 3) Diagnostics trial :
•Conduct to find better tests or procedures for diagnosing a
particular disease or condition. In a clinical trial, the investigator
first identifies the medication/device be tested. Then the
investigator decides what to compare it with and what kind of
patients might benefit from the medication/device.
4) Treatment trial
•Test experimental treatment , new combination of drugs , or
new approaches to surgery or radiation therapy .
5) Quality of life trial
•Explore ways to improve comfort and quality of life for
individual with a chronic illness.
6) Compassionate use trial
•Provide experimental therapeutics prior to final FDA approval to
patients whose optional with other remedies have been
unsuccessful. Usually case by case approval must be granted by
FDA for such exception.
5/18

6. Phases of clinical trial :
Clinical trial involving new drugs are commonly classified into four
phases . Each phase of the drug approval process is treated as a
separate clinical trial . The drug-development process will
normally proceed through all four phases over many years . If the
drug successful passes through Phases 0,1,2& 3 , it will usually be
approved by the national regulatory authority for use in general
population.
•Phase 0 : Pharmacodynamics & Pharmacokinetics
•Phase 1 : Screening for safety
•Phase 2 :Establishing efficacy of drug usually against a placebo
•Phase 3 : Final confirmation of safety & efficacy
•Phase 4 : Provide additional information about benefit & risk
6/18

7. Clinical trial Protocols :
1. General Information
2. Objectives and Justification
3. Ethical Consideration
4. Study Design
5. Inclusion , Exclusion & Withdrawal of subjects
6. Handling of product
7. Assessment of Efficacy
8. Assessment of Safety
9. Statistics
10. Data handling and Management
11. Quality control and Quality assurance
12. Finance And Insurance
13. Publication policy
14. Evaluation
15. Supplementation and appendices
7/18

8. 1.General Information
•Protocol title, protocol identifying number and date. All
amendments number and date(s)
•Name , address & contact number of the sponsor and the
monitor /CRO
•Name and title of the persons authorised to sign the protocol
amendments for the sponsor
•Name , title, address and contact number of sponsor’s medical
expert for the study
•Name ,title , address and contact number of the investigators
who are responsible for conducting the study ,along with their
consent letters
• Name ,Address & contact number of the institutions – clinical
laboratories and / or other medical & technical departments
along with the particulars of the head of institutions and the
relevant department.
8/18

9. 2. Objectives & Justification :
•Aims & objectives of the study , indicating the Phase to which the
study corresponds
•Name and description of the investigational products
•A summary of findings from non-clinical studies that potentially
have clinical significance & from clinical studies that are relevant to
the study
•Summary of the known & potential risks and benefits if any ,to
human objects
•A statement that the study will be conducted in compliance with
protocol , GCP and applicable regulatory requirements
•Descriptions of the inclusions & exclusions criteria of the study
population
•References to literature & data that are relevant to study & that
provide background for the study .
9/18

10. 3. Ethical consideration :
•General ethical consideration related to study
•Description of how patients/healthy volunteers will be informed
and how their consent will be obtained
•Possible reasons for not seeking informed consent.
4. Study Design :
•The scientific integrity of the study & the credibility of the data
from the study depend substantially on the study design.
Description of the study design should include
•Specific statement of primary & secondary end points ,if any ,to be
measured during the study
•Description of the type of the study ,study design ,blinding
technique ,randomisation & placebo controlled .
•A schematic diagram of the study design , procedures and stages
•Medications/treatment permitted & not permitted before and or
during the study.
10/18

11. •A description of the manner of packaging & labelling of the
investigational product.
•Duration of the subject participation and a description of the
sequence of all study period including follow up the study
•Proposed date of initiation of the study
•Maintenance of study treatment randomisation codes & procedures
for breaking codes.
•Documentation of any decoding that may occur during the study.
•Procedure for monitoring subjects compliance.
5) Inclusion , Exclusion & Withdrawal of Subjects
• Subject inclusion criteria : Specification of the
subjects(patients/Healthy volunteers ) including age , gender ,
ethic groups , Prognostic factors , Diagnostic admission criteria
etc. should clearly mentioned where relevant .
• Subject exclusion criteria , including are exhaustive statement on
criteria for pre admission exclusions.
11/18

12. •Subject withdrawal criteria and procedures specifying – when &
how to withdraw subjects from the treatment , type & timing of
data to be collected from withdrawn subjects , whether & how
subjects are to be replaced and follow up on withdrawn subjects
•Statistical justification for the number of subjects to be included in
the study.
6). Handling of Products
•Measures to be implemented to ensure the safe handling and
storage of the pharmaceutical products
•System to be followed for labelling of the product
•The label should necessarily contain the following information :
the words “ For Clinical Studies only “ , name or code of the study ,
name & contact number of Investigator , name of institution ,
Subjects identification code .
12/18

13. 7) Assessments of Efficacy
•Specification of the effect parameters to be used
•Description of how effects are measured and recorded
•Time & periodicity of effect recording
•Description of special analyses / test to be carried out
8) Assessment of Safety
•Specification of safety parameters
•Methods & periodicity for assessing & recording safety parameters
•Procedures for eliciting reports of and for recording and reporting
ADR / adverse events & inter current illnesses
•Type & duration of the follow up of subjects after adverse events
•Information on establishment of the study code ,where it will be
kept and when , how & by whom it can be broken in the event of an
emergency.
13/18

14. 9) Statistics
•Description of statistical methods to be employed
•Number of study subjects needed to achieve the study objective ,
and statistical consideration on which proposed number of subjects
is based.
•Procedures for managing missing data ,unused data & unauthentic
data .
•Procedures for reporting any deviation from original staitsitcal plan
should be stated & justified in protocol
•Selection of subjects to be included in final analyses (eg. All
randomized subjects/all dosed subjects/all eligible
subjects/evaluable subjects.
14/18

15. 10.Data handling and Management
A statement should be clearly made in the protocol that “That the
investigator(s)/institution(s) will permit study related monitoring
,audits ,ethics committee review and regulatory inspection(s)
providing direct access to source data / documents.
•Procedures for handling & processing records of effects and
adverse effects to the product(s) under the study.
•Procedures for keeping of patients records for each individual
taking part in the study .Records should facilitate easy identification
of the individual subjects .
15/18

16. 11. Quality Control & Quality Assurance
•A meticulous and specified plan for the various steps &
procedures for the purpose of controlling & monitoring the study
effectively.
•Specifications & instruction for anticipated deviations from
protocol.
•Allocation of duties & responsibilities with research team and
their co-ordination.
•Instructions to staff including study description (the way study
is to be conducted & procedures for drug administration) .
•Address & contact number etc. Enabling any staff member to
contact the research team any hour .
•Considerations of confidentiality problems ,if any rise.
•Quality control of methods and evaluations procedures
16/18

17. 12.Finance and Insurance
•All financial aspects of conducting and reporting a study arranged
and a budget made out.
•Information should be available about the sources of economic
support (eg. Foundation , private or public funds,
sponsor/manufacturer) . Likewise it should be stated how the
expenditure should be distributed eg. Payment to subjects
,refunding expenses of subjects , payment for special tests ,
technical assistance, purchase of apparatus ,payment of
investigator.
•Study subjects should be satisfactorily insured against any injury
caused by the study .
•The liability involved parties must be clearly agreed & stated before
the start of study
17/18

18. 13. Publication Policy
•A publication policy, if not addressed in a separate agreement,
should be described in the protocol .
14. Evaluation
•A specified account for how the response to be evaluated .
•Methods of computation & calculation of effects
•Descriptions of how to deal with report subjects withdrawn /
dropped out of the study
15. Supplements & appendices
The following documents should be appended with the protocol
•Information to study subjects and mode of providing it.
•Instructions to staff
•Descriptions of special procedures .
18/18

19. 19

20. THANK YOU
20