Introduction:
Clinical Research Protocols is a complete written description of and scientific rationale for a research activity involving human subjects.
- Sufficient information is to be gathered on the quality of the non-clinical safety to conduct the protocol and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought.
- The clinical trial design and objectives are written into a document called a clinical trial protocol. It is a document that states the background, objectives, rationale, design, methodology (including the methods for dealing with AEs, withdrawals, etc.), and statistical considerations of the study. It also states the conditions under which the study shall be performed and managed.
- Look for better ways to prevent disease in people who never had the disease or to prevent a disease from returning.
- The protocols mean:
– To clarify the research question.
– To compile existing knowledge.
– To formulate a hypothesis and objectives.
– To decide about a study design.
– To clarify ethical considerations.
– To apply for funding.
– To have a guideline and tool for the research team.
Parts of the Protocol:
1. Title Page.
2. Signature Page.
3. Content Page.
4. List of Abbreviations.
5. Introduction/Abstract.
6. Objectives.
7. Background/Rationale.
8. Eligibility Criteria.
9. Study Design/Methods (Including Drug/Device Info).
10. Safety/Adverse Events.
11. Regulatory Guidance.
12. Statistical Section (Including Analysis and Monitoring).
13. Human Subjects Protection/Informed Consent.
Title Page
- The title page introduces 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.
Signature Page
- Significance page of all healthcare professionals in the trial including contact details of the participating site. sponsor and sponsor medical advisor if not already given above.
Content Page
- This helps navigation through the document by a large number of different people that will be needed throughout the life of the trial.
List of Abbreviations
- All abbreviations used should be listed and defined. Accepted international medical abbreviations should be standardized within each project.
Eligibility Criteria
- Inclusion conditions and exclusion criteria must be met in are order to participate in a clinical trial.
Background Rationale
- All protocols require a section detailing the scientific rationale for a protocol and the justification in the medical and scientific literature for the hypothesis being proposed.
Objectives
- Objectives should be stated hypotheses to be tested.
- Each objective should have a corresponding discussion in the statistical section.
Introduction Abstract
- This summary should be only one to two pages long. It should give the reader sufficient information to understand the rationale for the trial.
Study Design Methods
- The study design section of the protocol should contain a stepwise description of all procedures required by the study.
Safety Adverse Effect and Side Effect
- These are the terms commonly associated with drugs. They are used by nurses and doctors, to refer to undesirable effects of a medication on a patient.
The Statistical Section
- The study objectives and study design elements in the statistical section should be described in the Objections section.
A discussion of Subject selection and exclusion proposed methods of patient recruitment
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