Brad Hall

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. On the one hand, you need to ask for enough funds to cover all your projected expenses. On the other hand, you don’t want your budget to be too expensive to the point that it gets rejected.  In this article, we’ll highlight some of the key considerations for creating a study budget.

In our previous article, we described the basics of creating a database using Microsoft Access to capture and safely store the data collected from investigator initiated trials (IIT). However, while Access excels in data organization and storage, you may want to use another software interface, such as Microsoft Excel, R, SAS, or SPSS for your data analysis. So as a follow-up, in this article, we’ll describe how to import and export data from Microsoft Access.

Whether you need to record data from a case report form or recruit participants for a new study, you likely have come across a database. Databases are systems to collect, organize, and manipulate large amounts of data. Being able to create and manage them is essential to ensure the success of your investigator-initiated trial (IIT).

When it comes to clinical studies, there are numerous types of software that you can use to help you create and manage your clinical database. However, many of these commercial tools that specialize in clinical data management, such as Oracle Clinical (Oracle), Clintrial (Clinsoft), or MACRO (Elsevier), may be too sophisticated and expensive for your needs. Luckily, you may already have an excellent database creation tool on your computer. If you have Office 365, or even previous versions of Microsoft Office, then you already have a database management program called Microsoft Access.  Unlike Word or Excel, however, which you likely already know how to use, Access is a tool that is often less employed. So, in this article, we’ll teach you all the basics of utilizing this powerful asset to help you build a database for your IIT.

As part of an investigator initiated trial (IIT), the investigator is also the study sponsor and is responsible for monitoring the trial’s progress at the site. According to the International Conference on Harmonization (ICH) guideline E6 on Good Clinical Practice (GCP), the sponsor needs to ensure that 1) the rights and well-being of the human participants are protected, 2) the study is being conducted according to the approved protocol and 3) the reported data are accurate, complete, and match that of the original source. The last component is critical to ensure that the study data can be eventually submitted for FDA approval. This is often achieved using source data verification (SDV), but what exactly is SDV?

Planning how and what data to collect in an investigator initiated trial (IIT) is one of the most challenging tasks for researchers. On the one hand, there needs to be sufficient data collected to support and test the study’s hypotheses. On the other hand, the over-collection of data results in wasted resources. The case report form (CRF), which is used to collect patient data for analysis, therefore needs to be carefully designed with great attention to details.  This article will highlight some useful tips for you to keep in mind when designing your CRF.

One of the standard documentations required for an investigator initiated trial is the informed consent form.  It is a letter to the participant that describes what the study is about, any potential risks and benefits, and the rights of the research participants. The main purpose of this form is to protect the participant from any harm. Since it is also a legal document, you can imagine that an informed consent form is very lengthy and in-depth. Fortunately, there are several templates available online that you can use as a guide. In this article, we’ll go over some of the sections that you’ll need to include.

An investigator-initiated trial (IIT) protocol for a clinical trial outlines how the study will be conducted. Depending on the sponsor, IIT protocols can vary significantly in requirements and depth, so it is always a good idea to first check with the sponsor. In fact, most sponsors will have their own specific protocol templates. In this article, we’ll outline some of the standard criteria that need to be included in most IIT protocols.

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. It can be quite an intimidating process if you have not done it before but don’t worry. This article will guide you through the basics of calculating the optimal sample size for your clinical study.

Designing a study for an investigator-initiated trial (IIT) can be a daunting task. Aside from satisfying the scientific and technical fundamentals, you also have to consider other factors (which may not be obvious) that can impact your study. A proposal with a weak study design will eventually lead to wasted time, effort, and money. This article will guide you through some of the critical steps to help maximize your IIT’s chances of success.

Drafting an application for a grant or an IIT (Investigator-Initiated Trial) can take an enormous amount of time and effort, so you want to be sure that your proposal has the highest chance of being funded. While there is always an element of luck, you can beat the odds by ensuring that your IIT stand out from the rest. In this article, we’ll highlight some of the critical factors that reviewers are looking for and how you can use them to your advantage to ensure your application is a success.