Aim of the course: To provide a comprehensive step by step training on all aspects of the research process from idea development till research output.
Type of the course: Modular course. Each module can be taken as a stand alone module or they can be combined into a full course. The course is composed of 6 essential modules and 3 optional modules which may or may not be selected by candidates for further study. Each module is taught over 2-3 full days.
Target candidates: Junior researchers, postgraduate degree students,  CRAs and research trial coordinators, candidates interested in a research career, mid-career researchers aiming to start independent research projects
Teaching Methods: plenary session followed by small group activities, problem based learning sessions and practical application in all modules.

COURSE CONTENT

Module 1: Introduction to Health Research

• Overview of the research business worldwide
• What does a career in research mean?
• Research career hierarchy in international research organizations
• Funding opportunities
• Financing considerations from the point of view of funding organizations
• Team building, capacity building and outsourcing
• Building a research portfolio
• Networking and international collaborations
• Research as part of academic degrees
• Innovation in research
• Developing research ideas
• Formulating research questions
• Searching the literature (as in module 1B)

Module 1B: Searching the Literature (optional stand alone module)

• How to develop a focused search strategy
• Use of different bibliographic database platforms
• Using Bolean logic
• Truncation, wildcards and adjacency features
• Sorting, saving and organizing your search results
• Saving email alerts of searches
• Searching open internet locations
• The grey literature
• Using citation managers software

Module 2: Research Design in Biomedical studies

• Formulating aims and objectives
• Study setting and timelines
• Study sample: sample size calculation and sampling methods
• Study outcomes and study measures
• Challenges in different study designs: Bias, confounding, matching and over matching, numbers of controls per case, sampling hard to reach populations, randomization, quality control
• Results in various study designs: odds, risks, ratios, relative risk, attributable risk
• P values and confidence intervals
• Ethical considerations and IRB
• Study design:
  • Cross sectional studies and surveys
  • cohort studies
  • case-control studies
  • interventional studies
  • systematic reviews and meta-analysis

Module 3: Clinical Trials

• Clinical trial design overview
• Design of phase I studies, phase II studies and phase III studies
• Innovative clinical trial design: hybrid designs and adaptive designs
• Issues in non randomized studies, before and after studies, historical controls and studies comparing paired organs
• Informed consent and ethical committee approvals
• GCP guidelines and EU directive for clinical trials
• Regulatory bodies and licensing
• How to randomize
• Controlling for bias and confounding
• Blinding
• Inclusion and exclusion criteria, stratification and subgroups
• End points in clinical trials: pharmacology endpoints, survival endpoints, response endpoints, time to event, quality of life endpoints
• Interpreting results in clinical trials

Module 4: Statistics at the Receiving End

• How to make sense of statistical results in published studies
• Describing your sample
• Basic statistical inference
• Statistical modeling
• Survival analysis
• Presenting your data correctly in tables and charts
• SPSS practical application

Module 05: Writing a research proposal

• The important information contained in the grant guidelines document
• Getting in the mindset of the reviewer
• Understanding the perspective of the funding organization
• Planning the implementation of the project
• Setting achievable targets
• Budgeting and justification
• Evaluation outcomes
• Making your case
• Finding the right grant opportunity
• Timelines and logical frameworks
• Collaborations and endorsements
• Addressing your practical, methodological and ethical issues

Module 06: Writing and Publishing Your Research

• Scientific language as opposed to narrative language
• Making valid conclusions from your results
• Discussing your findings convincingly
• Referencing, paraphrasing, plaigiarism
• Journal impact factors
• Instructions to authors
• The peer review process
• Copyright transfer
• Conferences and abstract publication

Module 07: Qualitative Research

• Nature of Qualitative data
• Qualitative data collection tools and methods
• Focus groups and interviews
• How to develop focus group and interview schedules
• How to conduct FGDs and interviews
• Analysing qualitative data
• Writing a qualitative manuscript for publication

Optional Modules:

08-Critical Appraisal of scientific papers

• Issues around study design
• Assessing the validity of trial methodology
• The consort statement
• Interpreting results
• Estimating the benefit and harm
• Estimating the magnitude of the effect
• Estimating the precision of the effect

09 - Evidence based practice

• What is Evidence Based Practice
• Why is it needed
• How did EBP develop
• How far our medical practice is evidence based
• Diagnostic and therapeutic pitfalls outside EBP
• Diagnostic logic and heuristics
• Finding the evidence
• Appraising the evidence
• Applying the evidence
• The difference between expected results in individual patients and reported results in groups of patients
• Individual patients and public policy
• Development of guidelines
• Licensing and approving for prescription

10 – Using questionnaires in clinical studies

• What do questionnaires measure
• Validated questionnaires for almost everything
• Is it reasonable to create your own questionnaire or to use a validated one
• Copyrighted tools
• Obtaining license to use
• Failure to obtain license results in difficulties at publishing time
• Translated versions and their suitability for use
• How to administer the questionnaire: You are not allowed to re-word
• What can errors in administering the questionnaire lead to
• Psychometric properties
• How to design a questionnaire if you have to
• How to validate your own questionnaire
• What results do questionnaire scores produce and how they are used
• Quality of life questionnaires in clinical trials, small item with major effect