This document provides guidance on developing clinical trial protocols. It explains that every clinical trial begins with developing a protocol, which is a document that describes how the trial will be conducted. The protocol ensures safety and integrity. Key topics that should be included in a protocol according to guidelines are: background, objectives, study design, selection and treatment of subjects, assessment of efficacy and safety, statistics, ethics, and data handling. The protocol language should be understandable to physicians, nurses, reviewers, and ethics boards. Regulations provide requirements for protocols regarding application processes and responsibilities of sponsors, investigators, and ethics committees.

1. Developing Clinical
Trail Protocols
Presented by
Nisha Yadav
Rollno. 2116102

2. Protocol
 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 objective(s), design,
methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial
subjects and integrity of the data collected.
 According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:
o Title Page (General Information)
o Background Information
o Objectives/Purpose
o Project Timetable/Flowchart
o Study Design
o Selection and Exclusion of Subjects
o Treatment of Subjects
o Assessment of Efficacy
o Assessment of Safety
•Discontinuation of the Study
•Statistics
•Quality Control and Assurance
•Ethics
•Data handling and Recordkeeping
•Publication Policy
•Project Timetable/Flowchart
•References
•Supplements/Appendices

3. The protocol language or content should be understood by the following:-
 Other physicians
 Nurses/CRAs (Clinical Research Associate)
 Scientific reviewers
 IRB (Institutional Review Board) members etc.
Clinical Trial Protocol
 Drug and cosmetics act 1940 – Schedule Y defines the clinical trials as the requirements and guidelines for
import and manufacture of new drugs for sale or for clinical trials. It describes the details of application
process for conducting clinical trials; responsibilities of the sponsor, investigators and the Independent
Ethics Committee.
 ICH Guidelines - ICH E6 (R2) Good Clinical Practice (GCP) Guideline was finalised in 1996 describing the
responsibilities and expectations of all participants in the conduct of clinical trials, including investigators,
monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials,
and incorporates addenda on the Essential Documents and on the Investigator's Brochure.
 The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a
view to addressing the application of GCP principles to the increasingly diverse trial types and data sources
being employed to support regulatory and healthcare related decision-making on drugs, and provide
flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.

4. CIOMS International Ethical Guidelines, Guideline 11 - A clinical trial cannot be justified ethically unless it
is capable of producing scientifically reliable results.
The NIH (National Institute of Health) provides many resources for protocol development to assist
investigators in writing and developing clinical research protocols that are in compliance with
regulatory/GCP requirements. Some NIH institutes have a mandatory requirement for using their protocol
template.
TITLE
 In this the introduction of document is done it's title, precise no., sponsor and author to reader.
 Any amendment should also bear amendment number and date.
 The protocol no. must clearly indicate the version number whether its draft or final and date of this
version.

5. Tittle page should include:
1.Full tittle should include summary study design, medicinal products, nature of treatment (eg:
treatment, prophylaxis and diagnosis) comparator placebo, indication patient population setting (eg:
in-patient, out-patient) Randomised double bind multiple studies.
2.Name and address of sponsor and monitor. Sponsor names and list of responsibilities with
agreed allocations.
3.Name and address of the person authorized to sign the protocol and protocol amendment for
the sponsor. Generally, chief investigator for multicentric trial or principle investigator for single
center trials.
4.Name, tittle, address and telephone number of the sponsor medical expert for the trial.
5.Name and tittle of the investigator who is responsible for conducting the trial, in the address and
telephone number of the trial site.
6.Name, tittle, address and telephone number of the qualified physician who is reponisible for all
trial site related medical decisions.
7.Name and address of the clinical laboratory and the other medical and/or technical and/or
institutions involved in the trial.

6. SIGNATURE PAGE
Signature page of all healthcare professionals in the trial including contact
details of participating site, sponsor and sponsor medical advisor if not
already given above.
CONTENT PAGE
It helps in navigation thorugh the document by large number of different
people which will be needed throughout the life of the trial

7. LIST OF ABBREVIATION
All abbrevations used should be listed and defined. Accepted international
medical abbrevations should be standardized within each project.
INTRODUCTION/ABSTRACT
It should be only one to two pages long. It should give the reader
sufficient information to understand the rationale for the trial, its objective
and the methods that will be used to achieve these objective.

8. OBJECTIVE
It should be stated clearly as hypothesis to be tested.
Each objective should have a corresponding discussion in the
statistical section.
BACKGROUND AND RATIONALE
All protocol require a section detailing the scientific rationale for a protocol and the
justification in medical and scientific literature for the hypothesis being tested.
Introductive section should be organized in a rational, sequential flow.
Double check all citations.
Common mistakes.
Name misspellings (including wrong initials),wrong journal names, wrong years of
publications, and wrong volume numbers.

9. ELGIBILITY CRITERIA-
DEFINATION
Inclusion and exclusion criteria are the conditions that must be
met in order to participate in a clinical trial.
The most important criteria used to determine appropriates for
clinical trial participation include age, sex, the type and stage of
a disease, treatment history, and other medical conditions.
 Writing eligibility criteria for patient
 Eligibility criteria are the largest barrier to clinical trials.
 There is no guideline for writing these criteria.
 Poorly written or poorly conceived criteria may affect the scientific validity of CT.
 Reasons for imposing elifibility criteria includes scientific rationales, safety
concerns, regulatory issues, and practical considerations.

10.  The points to be considered to write a good eligibility
criteria
 The number of eligibility criteria should be kept to a minimum.
 Criteria should include those absolutely necessary to ensure scientific validity and
patient safety.
 Eligibility criteria should be clearly defined and verifiable by an external auditor.
 Eligibility criteria should be straightforward and unambiguous.
 Failure to write eligibility criteria properly
 Leads to
Faliure to mimic practice.
Increased study complexity.
Increased costs.
Less number of patient getting recruited

11. STUDY DESIGN
The study design section of the protocol should contain a
stepwise description of all procedures required by the study.
A good study design section includes sufficient information for
the participating site.
 Parts of the study design section may include:
 Initial evaluations.
 Screening tests.
 Required lab tests.

12.  Details of treatment and procedures.
 Device specifications.
 Dose scheduling and modification.
 Calendars.
Safety
 Adverse effect and side effects are terms commonly associated with drugs.
They are used by nurses and doctors, to refer to undesirable effects of a
medication on a patient.
 The safety (or adverse events) section should include:
Detailed information for reporting adverse events, including reporting to
the FDA and/or the sponsor.
list of expected adverse events.

13. THE STATISTICAL SECTION
The study objectives and study design elements in the statistical section should be
described in the objectives section.
The description and the definitions of the toxicities in the statistical section match
those in the safety/AE section.
HUMAN SUBJECTS PROTECTION
 This section includes discussion of:
Subject selection and exclusion.
Proposed method of patient recruitment.
Minority representation.
Recruitment (or exclusion) of the special subjects, including vulnerable subjects.
List of potential risks and benefits, including justification for risks.

14. THANK
YOU