Animal Clinical Research Module - 1

Clinical research protocol
Research is Systematic collection, Analysis and Interpretation of data to answer a certain

question or solve a problem
Clinical research Clinical trial

Branches of medical Part of clinical research
Science
Systematic, observational Systematic experimental
and biomedical studies biomedical studies
Ultimate goal is to improve To evaluate the
the quality of life effectiveness and safety of
medications or medical
devices or biologics
Clinical research protocol: A complete written description of, and scientific rationale for, a
research activity involving human subjects
Why this protocol is important
1. To clarify the research question

2. To compile existing knowledge
3. To formulate a hypothesis and objectives
4. To decide about a study design
5. To clarify ethical considerations
6. To apply for funding
7. To have a guideline and tool for the research team
Parts of the protocol

Introduction
Abstract
Objectives (including study scheme)
Background
Rationale
Eligibility criteria
Study design/methods (including drug/device info)
Criteria for Evaluations

Study Treatments
Clinical Assessment
1. Clinical Laboratory Measurements

2. Evaluations by visit
3. Adverse experience reporting and
4. Documentation
Discontinuation and Replacement of subjects
Protocol violations
Statistical section (including analysis and monitoring)
Administrative, Ethical, Regulatory Considerations
Reference/ Appendices
Publication
1) Introduction
Study Subject / hypothesis should be clearly identified and briefly described in introduction
2) Abstract
Abstract is a summary of the information in a document.
Abstract must be:
Accurate - which correctly reflects the purpose and content of manuscript
Concise and specific – to make sentence informative and as possible as brief
Non evaluative – to report information objectively
3) Objectives
Objectives should be clearly mentioned as hypotheses to be tested.
Primary objective: the primary objective is to assess the clinical efficacy as measured by the in
pulmonary function over the six months treatment period.
4) Background
Identify the product to be studied and describe it briefly

1. On non-clinical studies- provides a brief summary of the non-clinical data that has
clinical significance.
2. On clinical studies-- provides a brief summary of the clinical data that are relevant to the
study or for approved drugs, to the prescribing information
5) Study rationale: Describe why it makes sense to study this product in this patient population
or in the event of an observational study, why the information is needed.
6) Risk / benefit assessment – how the specific risks of the product will be mitigated in the
study and why the potential benefits outweigh the risks should be clearly mentioned
7) Eligibility criteria
Subjects with a diagnosis of the specific disease intended to take in the study, who meet the
inclusion and exclusion criteria will be eligible for participation in this study.
8) Study design
This gives a very short description study.
The study design section of the protocol should contain a stepwise description of all procedures
required by the study.
8.1) Parts of the study design section may include:
 Initial evaluations
 Screening tests
 Required lab tests
 Details of treatment and supplementary procedures
 Agent information or device specifications
 Dose scheduling and modification
 Calendars
8.2) Types of study design used in clinical research
Observational study, Interventional study, Descriptive study, Analytical study, Cross sectional
study and Cohort study
8.3) General principles of study design
Study characteristics, type of study design to be used. The way in which study will be conducted
1. Single center
2. Double blind
3. Placebo control
4. Randomized / non randomized
5. Methodology
o Sampling
o Collection of data
o Statistical analysis
9) Subject selection
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.
9.1) Inclusion criteria (example): 22 years of age or older. Able to undergo the informed
consent/assent process. Medically stable in the judgment of the principal investigator. Greater
than 1 year since initial injury. Willing to attend all scheduled appointments
9.2) Exclusion criteria (example): All the mentally retarded and unconscious patients. Drugs
addicts. Patients unable to comply.
10) Study treatment
1. Concurrent Medication
2. Formulation of Test and control products
3. Packaging and labeling
4. Dose/Dosage regimen
5. Dispensing
6. Administration
7. Supply/Storage
10.1) Concurrent medication
All subjects should be maintained on the same medications throughout the entire study period, as
medically feasible, with no introduction of new chronic therapies.
Standard therapy for specific disease is allowed except for treatments noted in the exclusion
criteria
10.2) Formulation of Test and control products
Identify the test and control product, manufacturer, specify the formulation of the test article. If
drug must be reconstituted or otherwise prepared indicate in this section
10.3) Packaging and labeling

Brief explanation of how the drug will be packed and labeled and by whom.
10.4) Dose/Dosage regimen
Information of
 Dose
 Route of administration
 Dosing schedule
 Optimal timing between doses
 Adjustments for weight, age, meals and other pertinent information and
 Treatment periods
And also ideal clinical research protocol should explain about
 Dispensing
 Administration instructions
 Supply of drug at the site
 Storage
 Study drug accountability
 Measures of treatment compliance
10.5) Adverse event reporting
1. Describe your plan to report any adverse effects

2. Anticipated adverse event should be clearly documented
3. Identify the types and duration of follow up and treatment for the subjects that experience
and adverse events
11) Assessment of safety and efficacy
1. Be specific about the efficacy parameters

2. Include the methods and timing for assessing, recording and analyzing efficacy
parameters
3. Specify the safety parameters
4. Record and report properly all the adverse event and illness
12) Data access
1. Inform who will have access to the data and how the data will be used.
2. Address all study related monitoring, audits and regulatory inspections
13) Data collection plan
1. Define the types of the data collection instrument that will be used and list all the
variables
2. Specify if computerized database will be used
3. Identify what software will be used
4. Explain precautionary steps taken to secure the data
14) Statistical methods
1. Describe the statistical methods in detail

2. Include the number of subjects you are planning to enroll. For multi-center studies,
include the total number of site expected and the total number of subjects to be
enrolled across all sites
3. Provide the rationale for the sample size,
4. Procedure of accounting for missing, unused and spurious data
5. Procedure for reporting the deviations from the original statistical plan
15) Institutional review board (IRB) and independent ethics committee (IEC)
1. The protocol, consent form and protocol amendments should be reviewed and
approved by the IRB/IEC.
2. Serious adverse experiences regardless of causality should be reported to the IRB/IEC
16) Informed consent form
Informed consent should be prepared in accordance with the declaration of Helsinki, ICH GCP
(International council for harmonization good clinical practices), FDA (Food and Drug
Administration, USA), health insurance portability and accountability act (HIPAA) and local
regulations.
A proper executed, written, informed consent will be obtained from each subject prior to entering
the subject into the trial. Information should be given in both oral and written form in their native
language to subjects/ or their legal representatives about the study.

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Clinical research protocol

Research is Systematic collection, Analysis and Interpretation of data to answer a certain

Clinical research Clinical trial

Why this protocol is important

1. To clarify the research question

Parts of the protocol

Objectives (including study scheme)

Study design/methods (including drug/device info)

Criteria for Evaluations

1. Clinical Laboratory Measurements

Discontinuation and Replacement of subjects

Statistical section (including analysis and monitoring)

Administrative, Ethical, Regulatory Considerations

Abstract is a summary of the information in a document.

Abstract must be:

Accurate - which correctly reflects the purpose and content of manuscript

Concise and specific – to make sentence informative and as possible as brief

Non evaluative – to report information objectively

Objectives should be clearly mentioned as hypotheses to be tested.

Identify the product to be studied and describe it briefly

This gives a very short description study.

8.1) Parts of the study design section may include:

8.2) Types of study design used in clinical research

8.3) General principles of study design

10) Study treatment

10.1) Concurrent medication

10.2) Formulation of Test and control products

10.3) Packaging and labeling

10.4) Dose/Dosage regimen

And also ideal clinical research protocol should explain about

10.5) Adverse event reporting

1. Describe your plan to report any adverse effects

11) Assessment of safety and efficacy

1. Be specific about the efficacy parameters

12) Data access

14) Statistical methods

1. Describe the statistical methods in detail

16) Informed consent form

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