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8/4/2019 Protocol Designing in Ct
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Protocol :
Protocol A protocol is a document that states the reasoning behind and structure of a research
project Protocol also designed as a document that describes the background, rationale,
objectives, design, methodology, statistical consideration and organization of trial. The study
protocol can be viewed as a written agreement between the investigator, the participant and thescientific community
Protocol Outline :
A typical protocol has the following elements: Protocol Outline Title page Background
Information and scientific ratiionale Objectives Signature Page Study design Study Population
Protocol Design. :
Protocol Design. Study Procedure Statistical considerations Subject confidentiality
Informed consent process Literature references Supplements/appendices
Title Page :
Title Page Title page introduces the document, its title, precise number, sponsor and author to the
reader. Protocol title, protocol identifying number, and date. Any amendment should also bear
the amendment number and date. The protocol number must clearly indicate the version number,
whether it is final or draft and date of this version.
Title page.. :
Title page.. Full title should include Summary study design Medicinal products, Nature of
the treatment (e.g. treatment, prophylaxis, and diagnosis) Comparator Placebo, Indication Patient
population Setting(e.g. in-patient, outpatient) Randomized Double blind Multiple studies
Title page :
Title page 2. Name and address of the sponsor and monitor. Sponsor names and list of
responsibilities with agreed allocations 3. Name and title of the person authorized to sign the
protocol and the protocol amendment for the sponsor. Generally, Chief investigator for
multicentric trial or principle investigator for single center trials. 4. Name, title, address and
telephone number of the sponsor medical expert for the trial.
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Title page. :
Title page. 5. Name and title of the investigator who is responsible for conducting the trial,
and the address and telephone number of the trial site. 6. Name, title, address, and telephone
number of the qualified physician who is responsible for all trial site related medical decisions. 7.
Name and address of the clinical laboratory and other medical and/or technical departmentand/or institutions involved in the trial.
Signature Page. :
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 :
Content page This help navigation through the document by large number of different
people that will be needed throughout the life of the trial.
List of Abbreviations. :
List of Abbreviations. All abbreviations used should be listed and defined. Accepted
international medical abbreviations should be used. Project specific abbreviations should be
standardized within each project
Compliance Statement. :
Compliance Statement. The protocol should include a statement that the trial will be
conducted in compliance with the protocol, GCP and the applicable regulatory requirement.
Protocol Summary/Synopsis :
Protocol Summary/Synopsis This summary 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.
Background Information :
Background Information Name and description of the investigational product. A summary of
findings from nonclinical studies that potentially have clinical significance and form clinical
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trials that are relevant to the trial. Summary of the known and potential risks and benefit, if any,
to human subjects. Description and justification for the route of administration, dosage, dosage
regimen and treatment period.
Background information. :
Background information. Description of the population to be studied In short the data in this
background information should be able to justify the need for this study
Study Objective/Aims. :
Study Objective/Aims. A clinical trial often has both primary and secondary objectives, and
these should be identified as such in the protocol. Ideally, no more than 1 or 2 of each should be
included in a clinical trial.
Study Design.. :
Study Design.. A description of the trial design should include i. A description of the/design
of trial to be conducted e.g. double blind, placebo controlled, parallel design ii. A description of
the measures taken to minimize/avoid bias Randomization Blinding
Study design. :
Study design. iii. A description of the trial treatment and the dosage and dosage regimen ofthe IP. Also, include a description of the dosage form, packaging, and labeling of the IP iv. The
expected duration of subject participation, and description of the sequence and duration of all
trial periods, including follow up any. v. A description of stopping rule or discontinuation
criteria
Selection and withdrawal of subjects :
Selection and withdrawal of subjects Subject inclusion criteria Subject exclusion criteria
Subject withdrawal criteria
Treatment of Subjects :
Treatment of Subjects i. The treatment to be administered, including the name of all the
product, dose, the dosing schedule, the route/mode of administration and the treatment period ii.
Medication/ treatment permitted and not permitted before and or during the trial. iii. Procedure
for monitoring subject compliance
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Assessment of Efficacy :
Assessment of Efficacy i. Specification of the efficacy parameters ii. Methods an timing for
assessing, recording, and analyzing efficacy parameters.
Assessment of Safety :
Assessment of Safety Specification of safety parameters The methods and timing for assessing,
recording, and analyzing safety parameters Procedure for eliciting reports of and for recording
and reporting adverse event and intercurrent illnesses.
Statistics. :
Statistics. i. A description of the statistical methods to be employed, including timing of any
planned interim analysis. ii. The number of subjects planned to be enrolled. iii. The level of
significance to be used iv. Criteria for termination of the trial v. Procedure for accounting for
missing, unused, and spurious data.
Statistics.. :
Statistics.. vi. Procedures for reporting any deviation from the original statistical plan form
the original statistical plan should be described and justified in protocol and/or in the final report.
vii. The selection of subjects to be included in the analyses e.g. all randomized subjects, all dosedsubjects, all eligible subjects, evaluable subjects.
Direct access to source Data Document :
Direct access to source Data Document The sponsor should ensure that it is specified in the
protocol or other written agreement that the investigator/institution will permit trial related
monitoring, audits, IEC review, and regulatory inspection by providing direct access too source
data/documents.
Quality control and quality assurance :
Quality control and quality assurance Provide assurance on good clinical practice, quality of data
collection and refer to monitor and their role.
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Informed Consent :
Informed Consent Informed consent may be defined as a patients being given adequate
information about a clinical trial; understanding and voluntarily accepting the terms of a clinical
trial and agreeing to cooperate in its conduct.
Data Handling and Record keeping :
Data Handling and Record keeping This section deals with the database management- data entry
and validation and security/storage, rules for handling non-compliant patients, determining
evaluable data etc. Also, source data verification, audit, records retention-duration and location.
Financing and insurance :
Financing and insurance Financing and insurance should be discussed if not addressed in aseparate agreement Publication policy Publication policy should be discussed if not addressed in
a separate agreement.
Appendices :
Appendices Based on the protocol relevant appendices as elaborated should be attached
Summary of Product characteristics, data sheet for IP Measurement tools and their validation
Pharmacy information, shelf lives, dispensing procedure Methods for collecting patient samples,
their storage, dispatch and handling conditions
Appendices :
Appendices Clinical labs and tests Adverse reaction grading systems for particular safety
parameters Scoring systems of efficacy parameters Analysis diagram Declaration of Helsinki
Patient and parent/legal guardian consent form Subject information sheet for informed consent
Method of recruitment of patients/subjects to the trial
Thank YOU :
Thank YOU