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PROTOCOL
Soumyapottola19@gmail.com | https://clinicalda.blogspot.com
contents
1. Study title
2. Signature page
3. Content page
4. Objectives
5. Introduction
6. Study design and rationale
7. Inclusion and Exclusion criteria
8. Safety/Adverse events
9. Schema
10. Schedule of assessment table
11. List of abbreviation and Definition of terms
1. Study title
Definition :
A research protocol is written to detail a clinical study plan to meet
specified ethical norms for participating subjects. It is a plan to
obtain funding or conduct research. It is meant to clearly provide an
overview of a proposed study to satisfy an organization's guidelines
for protecting the safety of subjects.
Who reads protocol
The protocol language/content should be understood by
● Principal investigator
● Nurses/CRAs
● Clinical data management team members
● Scientific reviewers
● Clinical operators
● IRB members
Title page
● The title page introduce the document,its title,precise
number, sponsor and author to the reader.
● 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 the version.
Title page includes:
1. Title pages introduce the document, their title, precise number, sponsor and author to the
reader
2. Protocol title, protocol identifying number, and date
3. Any amendments should also bear the amendment number and date
4. The protocol number must clearly indicate the version number, whether it is final or draft and
date of this version
Elements full title should include : Placebo
Summary study design
Indication
Patient population
Medicinal products
Setting (ex: in-patient, outpatient)
Nature of the treatment (ex: treatment, prophylaxis and diagnosis)
Randomized
Double Blind
Multiple Studies
Comparator
Title page includes
● Name and address of the sponsor and monitor. Sponsor names and list of responsibilities with agreed
allocations
● Name and title of the person authorized to sign the protocol and the protocol amendments for the
sponsor. Generally, Chief Investigator for multiple center trials or Principal Investigator for single center
trials
● Name, title, address and telephone number of the sponsor medical expert for the trial
● Name and title of the investigator who is responsible for conducting the trial, and the address and
telephone numbers of the trial site
● Name, title , address and telephone number of the qualified physician who is responsible for all trial site
related medical decisions
● Name and address of the clinical laboratory and other medical and /or technical department and /or
institution involved in the trial
Protocol summary/synopsis
A clinical trial often has both primary and secondary objective, 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
2. Signature page
Signature page of the healthcare professional in the trial including contact
details of participating site, sponsor and sponsor medical advisor if not already
given above.
3.Content page
This helps navigating through the document by large number of different
people that will be needed throughout the life of the trial.
4.Study objectives/arms
A clinical trial often has both primary and secondary objective, 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
5.Introduction
A research protocol is written to detail a clinical study's plan to meet
specified ethical norms for participating subjects. It is a plan to obtain
funding or conduct research. It is meant to clearly provide an overview of a
proposed study to satisfy an organization's guidelines for protecting the
safety of subjects.
6.Study design and rationale
A description of the design of trial to be conducted
ex: double blind, placebo controlled, parallel design
2) A description of the measure taken to minimize/ avoid bias
A) Randomization
B) Blinding and dosage regimen of the IP. Also, include a description of the
dosage form, packaging and labeling of the IP
4) The expected duration of subject participation,and description of the
sequence and duration of all trial periods, including follow up any.
5) A description of “stopping rile” or “Discontinuation Criteria”
7.Inclusion and exclusion criteria
What are inclusion criteria?
Inclusion criteria comprise the characteristics or attributes that prospective research participants must have in order to be
included in the study. Common inclusion criteria can be demographic, clinical, or geographic in nature.
Example: Inclusion criteria You are running a clinical trial for a new treatment for individuals with chronic heart failure.
The following inclusion criteria apply:
● 18 to 80 years of age
● Diagnosis of chronic heart failure at least 6 months before trial
● On stable doses of heart failure therapies
● Willing to return for required follow-up (posttest) visits
People who meet the inclusion criteria are then eligible to participate in the study.
Exclusion criteria
What are exclusion criteria?
Exclusion criteria comprise characteristics used to identify potential research participants who should not be
included in a study. These can also include those that lead to participants withdrawing from a research study after
being initially included.
In other words, individuals who meet the inclusion criteria may also possess additional characteristics that can
interfere with the outcome Ethical considerations, such as be of the study. For this reason, they must be excluded.
Typical exclusion criteria can be:
ing a minor or being unable to give informed consent
● Practical considerations, such as not being able to read
continues……..
If potential participants possess any additional characteristics that can affect the results, such as another
medical condition or a pregnancy, these are also often grounds for exclusion.
Example: Exclusion criteriaIn the clinical trial for individuals with chronic heart failure, the following
exclusion criteria apply:
● The patient requires valve or other cardiac surgery
● The patient is unable to carry out any physical activity without discomfort
● The patient had a stroke within three months prior to enrollment
● The patient refuses to give informed consent
● The patient is a candidate for coronary bypass surgery or something similar
People who meet one or more of the exclusion criteria must be disqualified. This means that they can’t
participate in the study even if they meet the inclusion criteria.
8.Safety/Adverse Effects
● The methods and timing for assessing, recording, and analyzing safety parameters
● Procedure for eliciting reports of and recording and
reporting adverse event and intercurrent illnesses.
● Safety parameters will include the incidence of AEs, SAEs, treatment discontinuations or
dose interruptions or dose reductions due to AEs, AECIs, changes in ECOG performance
status, changes in clinical laboratory results (hematology, chemistry, and urinalysis),vital
sign measurements, observations during physical examination, and use of concomitant
medications.
9.Schema
Overall Study Design EXAMPLE:
10.Schedule of assessments
The Schedule of Activities (SoA) forms a key part of a Clinical Trial Protocol; it is usually presented as a
table with the columns detailing planned study 'visits' (Encounters) and the rows the details of study
activities (Activities) that are to be undertaken at that visit, and they are key to understanding how the ..
11.List of abbreviations and define of terms
Abbreviations are shortened forms of words and phrases and are a common occurrence in
research manuscripts as they can help make highly complex technical writing more
concise and easier to read.
CONCLUSION
Protocol is a blueprint for a study. It contains all the information necessary
Certain Information is required by regulation to be into protocol
The following are the key points that follow Data Management Protocol:
Data Recording
GCDMP
DMP
Data Capture
CRF Practices
Quality Assurance
Data Validation
Query Management
Statistical Analysis
Data Locking

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PROTOCOL

  • 2. contents 1. Study title 2. Signature page 3. Content page 4. Objectives 5. Introduction 6. Study design and rationale 7. Inclusion and Exclusion criteria 8. Safety/Adverse events 9. Schema 10. Schedule of assessment table 11. List of abbreviation and Definition of terms
  • 3. 1. Study title Definition : A research protocol is written to detail a clinical study plan to meet specified ethical norms for participating subjects. It is a plan to obtain funding or conduct research. It is meant to clearly provide an overview of a proposed study to satisfy an organization's guidelines for protecting the safety of subjects.
  • 4. Who reads protocol The protocol language/content should be understood by ● Principal investigator ● Nurses/CRAs ● Clinical data management team members ● Scientific reviewers ● Clinical operators ● IRB members
  • 5. Title page ● The title page introduce the document,its title,precise number, sponsor and author to the reader. ● 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 the version.
  • 6. Title page includes: 1. Title pages introduce the document, their title, precise number, sponsor and author to the reader 2. Protocol title, protocol identifying number, and date 3. Any amendments should also bear the amendment number and date 4. The protocol number must clearly indicate the version number, whether it is final or draft and date of this version
  • 7. Elements full title should include : Placebo Summary study design Indication Patient population Medicinal products Setting (ex: in-patient, outpatient) Nature of the treatment (ex: treatment, prophylaxis and diagnosis) Randomized Double Blind Multiple Studies Comparator
  • 8. Title page includes ● Name and address of the sponsor and monitor. Sponsor names and list of responsibilities with agreed allocations ● Name and title of the person authorized to sign the protocol and the protocol amendments for the sponsor. Generally, Chief Investigator for multiple center trials or Principal Investigator for single center trials ● Name, title, address and telephone number of the sponsor medical expert for the trial ● Name and title of the investigator who is responsible for conducting the trial, and the address and telephone numbers of the trial site ● Name, title , address and telephone number of the qualified physician who is responsible for all trial site related medical decisions ● Name and address of the clinical laboratory and other medical and /or technical department and /or institution involved in the trial
  • 9. Protocol summary/synopsis A clinical trial often has both primary and secondary objective, 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 2. Signature page Signature page of the healthcare professional in the trial including contact details of participating site, sponsor and sponsor medical advisor if not already given above.
  • 10. 3.Content page This helps navigating through the document by large number of different people that will be needed throughout the life of the trial. 4.Study objectives/arms A clinical trial often has both primary and secondary objective, 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
  • 11. 5.Introduction A research protocol is written to detail a clinical study's plan to meet specified ethical norms for participating subjects. It is a plan to obtain funding or conduct research. It is meant to clearly provide an overview of a proposed study to satisfy an organization's guidelines for protecting the safety of subjects.
  • 12. 6.Study design and rationale A description of the design of trial to be conducted ex: double blind, placebo controlled, parallel design 2) A description of the measure taken to minimize/ avoid bias A) Randomization B) Blinding and dosage regimen of the IP. Also, include a description of the dosage form, packaging and labeling of the IP 4) The expected duration of subject participation,and description of the sequence and duration of all trial periods, including follow up any. 5) A description of “stopping rile” or “Discontinuation Criteria”
  • 13. 7.Inclusion and exclusion criteria What are inclusion criteria? Inclusion criteria comprise the characteristics or attributes that prospective research participants must have in order to be included in the study. Common inclusion criteria can be demographic, clinical, or geographic in nature. Example: Inclusion criteria You are running a clinical trial for a new treatment for individuals with chronic heart failure. The following inclusion criteria apply: ● 18 to 80 years of age ● Diagnosis of chronic heart failure at least 6 months before trial ● On stable doses of heart failure therapies ● Willing to return for required follow-up (posttest) visits People who meet the inclusion criteria are then eligible to participate in the study.
  • 14. Exclusion criteria What are exclusion criteria? Exclusion criteria comprise characteristics used to identify potential research participants who should not be included in a study. These can also include those that lead to participants withdrawing from a research study after being initially included. In other words, individuals who meet the inclusion criteria may also possess additional characteristics that can interfere with the outcome Ethical considerations, such as be of the study. For this reason, they must be excluded. Typical exclusion criteria can be: ing a minor or being unable to give informed consent ● Practical considerations, such as not being able to read
  • 15. continues…….. If potential participants possess any additional characteristics that can affect the results, such as another medical condition or a pregnancy, these are also often grounds for exclusion. Example: Exclusion criteriaIn the clinical trial for individuals with chronic heart failure, the following exclusion criteria apply: ● The patient requires valve or other cardiac surgery ● The patient is unable to carry out any physical activity without discomfort ● The patient had a stroke within three months prior to enrollment ● The patient refuses to give informed consent ● The patient is a candidate for coronary bypass surgery or something similar People who meet one or more of the exclusion criteria must be disqualified. This means that they can’t participate in the study even if they meet the inclusion criteria.
  • 16. 8.Safety/Adverse Effects ● The methods and timing for assessing, recording, and analyzing safety parameters ● Procedure for eliciting reports of and recording and reporting adverse event and intercurrent illnesses. ● Safety parameters will include the incidence of AEs, SAEs, treatment discontinuations or dose interruptions or dose reductions due to AEs, AECIs, changes in ECOG performance status, changes in clinical laboratory results (hematology, chemistry, and urinalysis),vital sign measurements, observations during physical examination, and use of concomitant medications.
  • 18. 10.Schedule of assessments The Schedule of Activities (SoA) forms a key part of a Clinical Trial Protocol; it is usually presented as a table with the columns detailing planned study 'visits' (Encounters) and the rows the details of study activities (Activities) that are to be undertaken at that visit, and they are key to understanding how the ..
  • 19. 11.List of abbreviations and define of terms Abbreviations are shortened forms of words and phrases and are a common occurrence in research manuscripts as they can help make highly complex technical writing more concise and easier to read.
  • 20. CONCLUSION Protocol is a blueprint for a study. It contains all the information necessary Certain Information is required by regulation to be into protocol The following are the key points that follow Data Management Protocol: Data Recording GCDMP DMP Data Capture CRF Practices Quality Assurance Data Validation Query Management Statistical Analysis Data Locking