This document outlines the key components of a clinical trial protocol, including background information, objectives, trial design, selection of subjects, treatment procedures, efficacy and safety assessments, statistical analysis, quality control, data handling, and appendices. A protocol provides a plan and methodology for a clinical trial, ensuring scientific rigor and protecting subject safety and rights. It establishes objectives and procedures for all aspects of trial conduct and analysis.

1. ClinicalTrailProtocol
BY
RAKSHA
MERUGU RAJASHEKAR

2. TOPICS COVERED
1 What is Protocol
2 Content of Protocol
3 Why we need Protocol

3. PROTOCOL
o A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
o Every clinical investigation begins with development of protocol
o This also involves background, rationale, objectives, design,
methodology, statistical considerations, and organization of
clinical research.
General Information
o Protocol title, protocol identifying number, and date. Any
amendments should also bear the amendment numbers and
dates.
o Name and address of the sponsor and monitor.
o Name and title of the persons authorized to sign the protocol and
the protocol amendments for the sponsor.
o Name, title, address, and telephone number of the sponsor's
medical expert/ dentist (when appropriate) for the trial.

4. o Name and title of the investigator who is responsible for conducting the trial,
and the address and telephone number of the trial site.
o Name, title, address, and telephone number of the qualified physician (or
dentist, if applicable), who is responsible for all trial-site related medical (or
dental) decisions (if other than investigator).
o Name and address of the clinical laboratory and other medical and/or
technical department(s) and/or institutions involved in the trial.
Background Information
o Name and description of the investigational products.
o Summary obtained from non clinical studies that potentially have clinical
significance and related to clinical trials
o Summary of the known and potential risks and benefits, if any, to human
subjects.
o Description and justification for the route of administration, dosage, dosage
regimen, and treatment periods.
o Description of the population to be studied.
o Reference to the literature and other information which form a base of
clinical trial.

5. Trial objectives and purpose :
 There should be detailed description about the aim and objectives of a
clinical trial.
 Different phase of clinical trial have there specific objectives which should
be described in protocol.
Trial design:
The scientific integrity of the trial and the reliability of the data from the trial
depend substantially on the trial design.
The description of trial design include:
 A statement about the primary and secondary endpoints to be measured
during the clinical trail
ENDPOINT: To understand what will be the outcome of the study
intervention ,like
 Patient feels
 Stroke
 Quality of life
Primary endpoint : primary endpoint is for which the trial is powered
Secondary endpoint : secondary endpoint are endpoints that are
analyzed for which the trial may not be responsible

6.  Describe the type/design of trial like
 Double blind
 Placebo controlled
 Parallel design
 A schematic diagram of trial design, procedures and stages.
 A description of the measures taken to minimize/avoid bias, including:
 Randomization.
 Blinding
 A description about trial treatments ,the dosage and dosage regimen of the
investigational product. It also includes about the dosage form , labelling
,packaging of the investigational product.
 The expected duration of subject participation, and a description of the
sequence and duration of all trial periods, including follow-up, if any.
 A description of the "stopping rules" or "discontinuation criteria" for individual
subjects.
 Accountability procedures for the investigational product, including the
placebo and comparator, if any.
 The identification of any data to be recorded directly on the CRFs (i.e., no prior
written or electronic record of data), and to be considered to be source data.

7. SELECTION AND
WITHDRAWAL OF
SUBJECTS

8.  Whenever a medical researcher conducts a trial, they select participants with
appropriate health and medical histories.
 No participant can be excluded from the trail on the basis on colour , gender , or
any religious background.
 Subject withdrawal criteria (i.e., terminating investigational product
treatment/trial treatment) and procedures specifying:
(a) When and how to withdraw subjects from the trial/ investigational product
treatment.
(b) The type and timing of the data to be collected for withdrawn subjects
(c) Whether and how subjects are to be replaced.
(d) The follow-up for subjects withdrawn from investigational product treatment/trial
treatment.
 Subject inclusion and exclusion criteria are the conditions that must be met in
order to participate in clinical trial.
SELECTION AND WITHDRAWAL OF SUBJECTS

9. INCLUSION CRITERIA
AND EXCLUSION
CRITERIA

10. INCLUSION AND EXCLUSION CRITERIA
INCLUSION CRITERIA EXCLUSION CRITERIA
2
3 Type and stage of disease
1 Mentally retarded patient
2 Unconscious patient
3 Pregnant women
4 Treatment history 4
Patient who are unable to sign
ICF
Sex
1 Age
5 Other medical conditions

11. Treatment of Subjects:
Medication permitted
and not permitted
before/during the trial
Procedures for
monitoring
Treatment
administered to
To the subject

12. ASSESSMENT OF
EFFICACY & ASSESSMENT
OF SAFETY

13. Assessment of Efficacy & Assessment of Safety
Assessment of efficacy
 Specification of the efficacy
parameters.
 Methods and timing for assessing,
recording, and analyzing of
efficacy parameters.
Assessment of safety
 The safety and adverse event
section should be included.
 There should be procedure for
obtaining reports of and for
reporting and recording the
adverse event.
 Type and duration of the
follow-up subjects after
adverse events.
 Specification of safety
parameters.
 The methods and timing for
assessing, recording, and
analyzing safety parameters.

14. STATISTICAL SECTION

15. Statistical Section:
o Oversees the processes that group , summarize , analyze, and otherwise
present trial data for clinical interpretation.
o Statements of the planned sample size.
o Information about the timing and purpose of any planned interim analysis.
o Handling of missing or non-evaluable data.
o Procedures for reporting any deviation from the original statistical plan
should be described and justified in protocol and/or in the final report, as
appropriate.
o The selection of subjects to be included in the analyses (e.g., all randomized
subjects, all dosed subjects, all eligible subjects, evaluable subjects).
o Criteria for the termination of the trial should be mentioned.
Direct access to source data or documents:
o 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, IRB/IEC review, and regulatory inspections, providing
direct access to source data/documents.

16. QUALITY CONTROL &
QUALITY ASSURANCE

17. Quality Control & Quality Assurance
 This describes how the quality control and quality assurance processes will
be applied throughout the clinical trial.
 It defines the various quality-related tasks in the study , a quality plan
documents specific quality practices , resources , and activities relevant to
a specific projects.
Ethics:
 Essentiality
 Privacy and confidentiality
 voluntariness

18. DATA HANDLING AND RECORD
KEEPING

19. Data Handling and Record Keeping
o Describe procedures for data collection and recording.
o Detail methods implemented to ensure validity and quality of
data
o Confidentiality
o How long and where will the data from the study be kept and
who will be responsible for its safekeeping.
Financing and Insurance:
o Describe the budget of trial , it should contain a detailed item-
wise breakdown of the funds requested for , along with
justification for each item.
o Mention what are the local costs of participating?
 Pharmacy and laboratory costs
 Cost of staff training
o What can be the cost of staff for time spent conducting the study
at site

20. To clarify
the ethical
considerati
on
To apply for
funding
To have
guidelines
and tool for
research
team
To decide
about a
study
design
To
formulate
hypothesis
and
objectives
To clarify
research
question
and
compile
existing
knowledge

21. APPENDICES & CONCLUSION

22. Appendices
Based on the protocol , relevant appendices as elaborated should be
attached:
 Patient information sheet
 Patient consent form
 Data collection forms (case report form)
 Summary of product (test , procedure characteristics)
Conclusion
Protocol is a blue print for a study. It contains all the information necessary.