Development of a Protocol Formulation of a Research

Development of a Protocol Formulation of a Research Proposal Prof. C. V. Raghuveer. Ph. D Class

Definition of Protocol Detailed Plan of the Study. Every Research must have a written protocol

Why Protocol ? It is needed for clarification of thoughts. To think about all aspects of the study. It is a guide to ensure uniformity if a Research Team is working. It is essential for Ethical approval. It is essential for Grant application

A good protocol Should be adequate to answer research questions & achieve study objectives. • Should show that it is feasible in the particular set up for the study. • Should provide enough detail for another investigator to repeat the study with comparable conclusions.

Format for the protocol Project title. Project summary. Project description. Ethical considerations. Gender issues. References.

Project title Descriptive. Concise.

Project Summary • Concise. • Summarize all elements of protocol. • Stand alone with no reference to project description.

Project Description includes Rationale. Objectives. Methodologies. Data management & analysis.

Project Description (contd. ) • Rationale: * Should answer the why and the what. * Similar to Introduction in a research paper * Should include a brief note on relevant published studies on the subject.

Project description (contd. ) • Objectives : * Statements of the research questions. * Should be simple & specific * Include primary & secondary objectives.

Project description (contd. ) Methodology : * Most important part of protocol. * Includes information on study design, study subjects, interventions, observations to be made and sample size.

Project description (contd. ) • Methodology (contd. ) : * Study design: should be explained in relation to study objectives. * Study subjects/ participants. - Inclusion criteria. - Exclusion criteria. - Allocation to groups. - Criteria for discontinuation.

Project Description (contd. ) Observations : * Information regarding observations to be made, how frequently and by what means e. g, Questionnaire/ Lab tests/ others. * sample size: calculation, justification, ethical considerations while calculating.

Project Description (contd. ) Data management and Analysis : * How data will be managed- coding ? , monitoring/ verification. * Statistical methods for data analysis to be outlined.

Ethical Considerations Applies to all types of research. Ethical Committee approval including written informed consent.

Gender issues �Justification regarding choosing or not choosing males/ females.

References The protocol should end with relevant references on the subject

How to cite and References ? Vancouver Style. Harvard Style. make list of

Formulation of Research Proposal �Written document to apply for funding. �Includes all components of Protocol & more. �Should help to convince funding agency that the project is worthy of support

Factors that help in funding Importance & relevance of project to the interest of the funding agency. Quality of research design. Ability of investigators. Capacity of Institutional facility. Ability of Institution to handle administrative and financial procedures.

Factors that influence funding agency (contd. ) �Satisfactory ethical considerations. �Realistic and justifiable budget. �Reasonable time for completion of project. �Understanding of anticipated problems. �Clarity and style of written protocol.

How do Funding agencies accept proposals Funding agencies invite certain institutions to submit proposals. Funding agencies advertise in certain areas of interest. Open door policy of funding agencies for any good proposal

Components of a Research Proposal Title page. Project summary. Project description. Ethical considerations. Gender issues. Time table. Problems anticipated. Budget. References. Curriculum-Vitae of Investigators.

Title Page Project Title. Principal Investigators. Institution. Duration of Project. Funding requested.

Project summary & project description. Similar to what is written in the Protocol. Project Summary – reveal persuasively strengths & importance of the Project description- under Rationale, indicate relevance of project to interest of funding agency. Mention previous work to indicate strength of investigator. Mention pilot study to demonstrate feasibility

Ethical considerations Gender issues Similar to what is mentioned under Protocol.

Timetable. Include: * Preparatory phase: Training of personnel, procurement of equipment, consumables & complete a pilot. * Duration of data collection. * Time for writing report. * Progress report a must for release of funds

Problems anticipated * Demonstrate awareness of obstacles and difficulties which may interfere. * Remedial measures to deal with them.

Budget Itemize the budget request: * Personnel. * Equipment. * Supplies/Consumables. * Patient care. * Travel. * Data processing. * Communications. * Secretarial. * Publications.

Budget Contd. Budget justification: All items should be justified. E. g, are major equipment essential ?

References and C V A number of recent references on the subject should be cited. C V of Investigator to indicate her/his ability to undertake the Project. Biographical sketch. Track record. Preliminary work.