This document outlines the components of a research protocol, including: general information about the study team and sponsor; background information on the topic; objectives and purpose; trial design; selection and withdrawal of subjects; treatment methods; assessment of efficacy and safety; statistical analysis; ethics considerations; data handling; and a project timetable. A research protocol provides the plan and guidelines for a clinical trial, clarifying the research question, compiling existing knowledge, formulating hypotheses and objectives, and deciding on study design and ethical issues. It serves to guide the research team and provide structure for the clinical project.

1. PROTOCOL
Presented by;
Aiswarya . A. T,
First year M.Pharm,
Department of Pharmacy Practice,
Grace college of Pharmacy.

2. A research protocol is a document that
describes the background, rationale,
objectives, design, methodology, statistical
considerations, and organization of a
clinical research project.
The protocol contains a study plan on
which the clinical trial is based.

3. Why a protocol?
To
clarify
the
resear
ch
questi
on
To
compil
e
existin
g
knowl
edge
To
formula
te a
hypoth
esis
and
objecti
ves
To
decide
about a
study
design
To
clarify
ethical
consid
eration
s
To
apply
for
fundi
ng
To have a
guideline
and tool
for the
research
team

4. 1. General Information
Protocol
Sponsor
Persons authorized to sign the protocol
Sponsor's medical expert
Investigator
Clinical laboratory and other medical &
technical departments & institutions involved
in the trial.

5. 2. Background Information
Investigational product
Summary of findings from nonclinical studies
Risks and benefits
Description
GCP
Population
References to literature and data that are relevant

6. 3. Trial Objectives and Purpose
Hypothesis
Primary Objectives
Secondary Objectives
Potential Risks and benefits

7. 4. Trial Design
Endpoints
Type/design of trial to be conducted
a) Randomization.
b) Blinding
Trial treatment
Duration of subject participation
Stopping rules" or "discontinuation criteria
Accountability procedures

8. 5. Selection and Withdrawal
of Subjects
Subject inclusion criteria
Subject exclusion criteria
Subject withdrawal criteria

9. 6. Treatment of Subjects
Treatment
Medication permitted and not permitted before/during
the trial
Procedures for monitoring
7. Assessment of Efficacy
8. Assessment of Safety

10. 9. Statistics
Statistical methods
Criteria for the termination
level of significance
Procedure for accounting for missing, unused,
and spurious data.
Procedures for reporting any deviation
Selection of subjects

11. 10. Direct Access to Source Data /
Documents
11. Quality Control &Quality Assurance
12. Ethics
Approval
Informed consent
Patient withdrawal / discontinuation.
Trial monitoring.

12. 13. Data Handling and Record
Keeping
14. Financing and Insurance
Funding source
Conflict of interest
Subjects’ payment
Cover for managing adverse events

13. 16. Project timetable/ Flowchart
17. References
18. Supplements/ Appendices