Just because something is statistically significant does not necessarily mean it’s clinically important. Clinical significance measures the extent that a change can create a meaningful response for the patient. … Many researchers will rush to conclusions based on statistically significant data without thinking about whether or not the results actually matter.
As the name implies, inferential statistics allows you to use sample statistics to make predictions about the population. In order to make accurate predictions, the sample needs to be truly representative… selecting an adequate sample size will help ensure that your inferences are accurate.
After you’ve collected the data from an investigator initiated trial, the next step is to run a series of statistical analyses to gather meaningful insights. … The three main types of descriptive statistics include distribution, central tendency, and variability.
A strong study design for an investigator initiated trial (IIT) requires a well-planned budget. After all, even the best science can’t happen without money. Good budgeting is an art form; there are numerous factors you have to consider and balance. … Build in buffers, direct costs, and indirect costs.
In most organizations, Microsoft Access stores data while you use another tool like Excel, R, SAS or SPSS for analysis. Use the External Data tab in Access to export tables or queries. But first run a query to select only the needed fields (e.g. subject IDs, results) to avoid exporting sensitive identifiers.
Databases are systems to collect, organize, and manipulate large amounts of data. … Microsoft Access is a tool you may already have; its four core principles — tables, queries, forms, reports — are the foundation of a well-designed database for your IIT.
As part of an investigator initiated trial (IIT), the sponsor must ensure the reported data are accurate, complete, and match the original source. Source data verification (SDV) checks that case report forms align with original records. Risk-based monitoring (RBM) and source data review (SDR) help optimize quality and cost.
Case report forms (CRFs) are the foundation of an investigator-initiated trial (IIT), but can be challenging to get right. … Good CRF design improves data accuracy, trial efficiency, and ultimately the credibility of your results.
What should be included in an informed consent form for an investigator-initiated trial (IIT)? … One of the key things to keep in mind is that you must write the form in language that can be understood by someone with a grade 5–6 reading level.
An investigator‑initiated trial (IIT) protocol outlines how the study will be conducted. A comprehensive protocol includes sections such as: title page, background information, trial rationale and objectives, trial design, selection and withdrawal of subjects, treatment of subjects, assessment of efficacy, assessment of safety, statistics, direct access to source data/documents, quality control and quality assurance, ethics, data handling and record‑keeping, financing and insurance, publication policy, and other supplementary information.
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