COMPONENTS OF A

CLINICAL STUDY
PROTOCOL
INTRODUCTION

• Every clinical investigation begins with the development of a clinical protocol

• The protocol is a document that describes how a clinical trial will be conducted
(the objectives, design, methodology, statistical considerations and
organization of a clinical trial,) and ensures the safety of the trial subjects and
integrity of the data collected
Components of a Protocol

Background Objectives and Study design Study

Title page enrollment and
information purpose and end points withdrawal

Study Efficacy Safety Statistics

procedures and Clinical
schedule assessment assessment monitoring analysis

Source Ethics/ Data handling

documents and Quality control Protection of and record Publication
access and human subjects keeping policy
assurance

Study Supplements/
References
administration Appendices
General Information

• Details of the protocol: Protocol title, protocol identifying number, date, and any
amendment(s)
• Details of the sponsor, investigator(s), and sponsor's medical expert

• Details of the person(s) authorized to sign the protocol

• Details of the qualified physician who is responsible for trial-site related medical
decisions (if other than investigator)
• Details of the clinical laboratory(ies) and other medical and/or technical
department(s) and/or institutions involved in the trial
Background Information

• Details of the investigational product(s)

• Summary of findings from nonclinical studies and clinical trials

• Summary of the known and potential risks and benefits to human subjects

• Description of and justification for the route of administration, dosage regimen, and
treatment period(s)
• Description of the population to be studied

• References to literature and data that provide background for the trial
Objectives and Purpose

• A detailed description of:

– Objectives of the trial

– Purpose of the trial

Study Design and End-points

• Description of the type/design of trial to be conducted and a schematic diagram of

trial design, procedures, and stages
• End-points of the study

• Measures taken to minimize/avoid bias (randomization, blinding etc.)

• Description of the trial treatment(s) (including packaging and labelling)

• Duration of participation (including sequence and duration of each period and follow-
up)
• Discontinuation criteria
Selection and Withdrawal of Subjects

• Inclusion criteria
• Exclusion criteria
• Withdrawal criteria along with procedures specifying:
– When and how to withdraw subjects from the trial/ investigational product treatment
– Type and timing of the data to be collected for withdrawn subjects
– Whether and how subjects are to be replaced
– Follow-up for subjects withdrawn from investigational product treatment/trial
treatment
Study procedures and Schedule

• Name of the product to be used

• Dose and dosing schedule

• Route of administration

• Treatment period (including follow-up)

• Medication(s)/treatment(s) permitted (including rescue medication) and not permitted

before and/or during the trial
• Procedures for monitoring subject compliance
Assessment of Efficacy and Safety

• Specification of efficacy and safety parameters

• Methods and timing for assessing, recording, and analyzing these parameters

• For safety:
– Procedures for eliciting reports of and for recording and reporting adverse events

– Type and duration of the follow-up of subjects after adverse events

Statistics

• Statistical methods employed

• Number of subjects planned to be enrolled
– Reason for choice of sample size, including calculations of the power of trial and
clinical justification
• Level of significance to be used
• Criteria for termination of trial
• Procedure for accounting for missing, unused, and spurious data
• Procedures for reporting any deviation(s) from the original statistical plan
• Selection of subjects to be included in the analyses
Other Components of a Protocol

• Direct Access to Source Data/Documents

• Quality Control and Quality Assurance

• Ethics

• Data Handling and Recordkeeping

• Financing and Insurance

• Publication Policy

• Supplements
THANK YOU