Source Data Verification in Investigator-Initiated Trials: A Risk-Based Monitoring Guide
Learn how to use source data verification within a risk-based IIT monitoring plan, select critical data, define triggers, and avoid the 100 percent SDV myth.
How to Prepare Case Report Forms for Investigator-Initiated Trials
Design protocol-driven case report forms for investigator-initiated trials. Covers traceability, data minimization, eCRF controls, eye-care fields, testing, and an editable CRF design template.
Informed Consent for Investigator-Initiated Trials: A Practical Design Guide
Build an informed-consent process for an investigator-initiated trial: understandable materials, voluntary discussion, documentation, and ongoing review.
How to Prepare a Protocol for an IIT
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.
How to Calculate Sample Size for an Investigator Initiated Trial
Sample size is one of the most important criteria when it comes to designing an investigator initiated trial. After all, selecting the wrong size can be disastrous for a study later on. This article will guide you through the basics of calculating the optimal sample size for your clinical study.
How to Prepare a Study Design for an IIT Proposal
Designing an investigator-initiated trial (IIT) is challenging. Beyond scientific and technical fundamentals, hidden factors can affect success. A weak design risks wasted time, effort, and money. This article outlines key steps to strengthen your proposal and improve the likelihood of achieving meaningful, impactful results in your IIT.
How to Make your IIT Proposal Stand Out
Drafting a grant or IIT application takes significant time and effort, so maximizing funding chances is crucial. While luck plays a role, you can stand out by aligning with key reviewer expectations. This article highlights critical factors to strengthen your proposal and increase the likelihood of success.
How to Draft a Successful IIT Proposal
Drafting a proposal for an IIT or grant is challenging, even for experienced academics. Securing funding is harder still. This article shares proven strategies to strengthen your application, improve clarity and impact, and maximize your chances of approval and success in today’s competitive research funding environment.
Generating and Screening Ideas for your Investigator Initiated Trial
Identifying an unmet medical need is only the first step. Next, generate and refine study ideas to develop a strong proposal. Since funding is limited, applying clear selection criteria ensures only the best concepts move forward, saving time, effort, and increasing your chances of securing support.
Identifying an Unmet Need for your Investigator Initiated Trial
When drafting a grant or Investigator-Initiated Trial, the first step is identifying an unmet scientific or medical need. Rushing this stage weakens your proposal and hinders funding success. This article outlines a detailed approach to identifying and evaluating unmet needs, helping you build stronger, more convincing study applications.
