Collection of protocols and selection of suitable methods according to work plan.

With respect to Clinical research

 Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.

 A protocol is directed by a chief researcher with the following aims

Aims

1) To raise the question to be researched and clarify its importance.

2)  To collect existing knowledge and discuss the efforts of other researchers who have worked on the related questions (Literature review).

3) To formulate a hypothesis and objectives.

4) To clarify ethical considerations.

5)  To suggest the methodology required for solving the question and achieving the objectives.

6)  To discuss the requirements and limitations in achieving the objectives.

 The most difficult stage of conducting a research project is the preparation of a protocol that results in a short comprehensive document that clearly summarizes the project. It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results. If the protocol is poorly prepared and not followed, it is unlikely that the project will yield the desired results.

 The protocol should adequately answer the research question. The research design must be sound enough to yield the expected knowledge. It should provide enough detail (methodology) that can allow another investigator to do the study and arrive at comparable conclusions. The proposed number of participants is reasonably justified and the scientific design is adequately described.

 The key points of the proposal should include justification for the need of the project and a detailed plan for the investigation

What is the question? (Hypothesis)

Ø  What is it to be investigated?

Ø  Why    is          the       study   important?       (Significance)

Ø  Where  and      when   it          will      take     place?

Ø  What   is the   methodology? (Procedures     and      methods          to         be used).

Ø  How    are       you      going   to         do        it?        (Research        design)            

Ø  Proposed time table and budget

Ø  Resources required     (technical, scientific and financial)

Methods and Materials 

 It should describe in detail the ‘Where’, ‘Who’, ‘How’ the research will be conducted. It explains the study design and procedures and techniques used to achieve the proposed objectives. It defines the variables and demonstrates in detail how the variables will be measured. It details the proposed methodology for data gathering and processing. 

Methodology composes an important part of the protocol. It assures that the hypothesis will be confirmed or rejected. It also refers to a thorough strategy to attain the objectives.

 The methods and materials are divided into various subheadings: 

a) study design (cross-sectional, case-control, intervention study, etc.): Proper explanation should be given as to why a particular design was chosen (on the basis of proposed objectives and availability of resources). A study design is in fact the researcher’s general plan to acquire the answer (s) to the hypothesis being tested. Here, strategies will be applied to develop balanced, correct, objective and meaningful information. It explains the methods that will be used to collect and analyze data.

Proper selection of the study design is important to attain reliable and valid scientific results. Ethics, logistic concerns, economic features and scientific thoroughness will determine the design of the study. The chief concern is given to the legality of the results including potential bias issues. Randomized controlled clinical trial is the best to document a causal relationship between an exposure and its outcome.

 b) study population (study subjects) Where are you going to do the research and who is the study population (why doing research in this place and why selecting this population?). It describes in detail about the study subjects, all aspects of the selection procedure and sample size calculation. Proper definition of eligibility, inclusion, exclusion and discontinuation criteria of the study subjects should be stated.

 c) sample size Sample size calculation is recommended for economical and ethical reasons. The calculation of the sample size must be explained. The sampling technique should be mentioned, e.g., randomization that will be used in order to obtain a representative sample for your target population. Each step involved in the recruitment of the study subjects should be described according to the selection criteria (inclusion and exclusion criteria).

 “Informed consent” should be mentioned (Permission granted in full knowledge of the possible consequences).

 d) Proposed intervention Full description of proposed intervention should be given. Here, all the activities and actions should be recorded and thoroughly explained in their order of occurrence.  

•When using    drugs,  both scientific and brandname should be mentioned followed by the name of the manufacturing company, city, and country. Drug route, dosage, frequency of administration, and total duration of treatment with the drug should be mentioned.

•When using apparatus its name should be given followed by the name of the manufacturer, city and country.

 

e) Data collection methods, instruments used

Data collection tools are:

•Retrospective data     (medical          records)          

•Questionnaires                      

•Interviews (Structured,     Semi-Structured)

•Laboratory  test     

•Clinical  examinations  

•Description    of   instruments,     tools    used     for       data     collection,        as well as the methods used to test the validity and reliability of the instrument should be provided 

A suitably drafted protocol has the following advantages

Benefits

·         Allows the researcher to plan and review the project's steps.

·         Serves as a guide throughout the research.

·         Idea of time and budget estimates.

R    References

Protocol Writing in Clinical Research Journal of Clinical and Diagnostic Research. 2016 Nov, Vol-10 (11)