Before you start writing your manuscript, decide on which journal you would like to submit your work to. This will help you format your manuscript properly and include all the necessary pieces of information to increase the chances that your manuscript will get accepted. Many researchers actually leave this step until the end of their project, but we recommend that you should start this process as early as possible. In this article, we’ll go over some of the tips and tricks to guide you on how to format your manuscript for some of the common ophthalmology journals.

Months after submitting your manuscript to a journal for publication, you finally get an e-mail from them with a decision. If you’ve done good work and were careful in your review process, then the typical answer would be “accept after revisions.”  For instructions on how to prepare a manuscript for publication, please refer to our previous articles. However, there are times when you are asked to complete additional experiments, or worse, get outright rejected. In this blog, we’ll describe what to expect in the review process and how to handle reviewers’ comments.

After completing your manuscript and choosing which journal to submit your work, the next step is to prepare your work for final submission. If you have never submitted your work to a journal before, then the process can be a bit of a nuisance since there are a lot of checkboxes you’ll have to tick. In this article, we’ll share with you all of the key essential steps that will help streamline your submission process.

After months of hard work of analysis and writing, you are finally ready to submit the results of you investigator initiated trial to a reputable journal. But which one should you submit to? Considering there are tens of thousands of journals, it can be a challenge to select the right one. Many researchers will often leave the decision on which journal to publish with until the very end of the research process; however, this can lead to several problems. Each journal has its own set of requirements for publication, so more often than not, you will have to reformat your manuscript to match the journal's expectations. In some cases, you may even have to complete additional experiments. So instead of leaving this important decision to end, we recommend that it's one of the first questions that you answer early on to help save you time and effort later on. In this article, we'll cover some of the key aspects of selecting the best journal for your study.

Whether you’re writing a manuscript or doing a literature review, you will have to cite and reference your sources. In the past, researchers had to keep track of their references by hand – it’s hard to imagine what a nightmare that was! Thankfully, today there are various options for citation managers to keep track of references and make the entire process more efficient and less stressful. In this article, we’ll cover four of the most commonly used citation managers used in academia – EndNote, Mendeley, RefWorks, and Zotero.

Unless you love writing, drafting a manuscript for your investigator initiated trial (IIT) can be a dreadful task. Where do you even begin? What do you have to include? It’s easy to procrastinate when it comes to writing, but the faster you finish it, the faster you can wrap up your study and move on to the next idea. We find that relying on inspiration tends not to work most of the time, so we recommend following a set template to help you get the job done. In this article, we’ll describe the key sections of a manuscript, what to include, and some tips on making this process as painless as possible.

Whether you’re planning to write a publication on your investigator-initiated trial (IIT) or a review paper, the first step is to perform a literature review. At first, attempting to navigate through the vast ocean of knowledge can seem quite intimidating. Where do you even begin? What information do you need to collect? In this article, we’ll describe some of the key steps that will help you efficiently tackle this process.

Investigator-initiated trials (IIT) are often fairly complex in their methodologies. Additionally, given the large amounts of data, the results from clinical studies can be overwhelmingly difficult to understand. Therefore, it is critical that you’re able to distill your study results in a way that’s easy to understand for your audience. One of the best strategies to summarize and communicate results is through the use of tables and figures. These elements are the first things that readers look for, and it’s also likely the last thing they’ll remember about your study. In this article, we’ll discuss some guidelines that will help you produce effective tables and figures for your studies. 

After long hours of data analysis and statistical tests, you finally determine that the outcome in the treatment group was statistically better than that of the control group. But before you can jump to any conclusions, you first have to determine whether the results are clinically significant. In other words, does it really matter? In this article, we'll discuss why you should consider both statistical significance and clinical significance in your results analysis. 

Investigator initiated trials are conducted to answer a research question or hypothesis about a general population. Since it would be too expensive and time consuming to test the entire population, we can only sample a portion of the population and hope that the sample is representative. We can use descriptive statistics to describe the sample, and then use inferential statistics, which we will discuss in this article, to make predictions about the entire population.

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. For most people, statistical analysis can seem daunting because they’re not sure where or how to begin. So, in this article, we’ll outline how you can get started using descriptive statistics.

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.

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.

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.

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The Sengi team is led by Dr. Brad Hall, a vision scientist and expert medical writer. A regular peer reviewer for several medical and ophthalmology journals, Dr. Hall has authored a multitude of articles personally, is a successful grant writer, medical writer, and master of the art of simplifying data and statistical analysis. Since launching in 2015, Sengi has provided medical writing and biostatistics analysis expertise to SMBs and researchers around the world that lacked the necessary means to share their scientific breakthroughs outside of the lab. Sengi’s work has enabled these companies to put advanced technology into the hands of those who need them most.