Creating exceptional clinical research source documents is crucial for the success, compliance, and accuracy of a clinical trial. The best way to know if your source is ready to be put to use is to know and understand the Clinical Study Protocol (CSP), off of which you are writing your source. The CSP should be the number one resource a medical writer uses when creating source documents as it explains exactly what happens in each step of the trial.
First step is to read the CSP. Once you have a general idea of what each source document should contain, it is time to dig a little deeper: find these three targeted sections in the CSP to gather the most crucial trial information needed to write an outstanding clinical trial source document.
Inclusion and Exclusion Criteria
This section, included in every CSP, has some of the most viable information needed to reach the endpoints in question for the study. The source documents are to be written in a way that collects information about a patient either by asking them directly, or through observation from clinical trial staff or lab. To use this section of the CSP to your advantage, go through each of the inclusion and exclusion criteria and make sure that there is a question in your source documents that confirms each criterion.
For example, if an exclusionary criterion in a particular study omits a patient who has a BMI that is greater than or equal to 31, the demographic source document(s) will need to include a BMI question. Not all criteria are explicitly stated in the study activities portion of the CSP. To make an even more valuable source document document, write a note in italics under the question that states the exclusionary value and include the criteria number.
Study endpoints are the reasons why the clinical trial is being conducted in the first place. Thus, the study endpoints section in the CSP is where most answers to questions asked during source creation can be answered.
The process for using the study endpoints to help create a great document is much like using the inclusion and exclusion criterion. Simply find the endpoints in the CSP and look for specific values, queues, or milestones that need to be monitored throughout the study.
One way to include information about a desired outcome is to write a note about the endpoint in a source question. Or, this information can be included in the details and directions section of a source document.
For example, one study endpoint measures a Six Minute Walk Test in patients at 30 days post treatment and again at 1 year. Within the source, create a question that asks for the difference between the walk tests at the two dates so the investigator or staff can assess if there is a change from baseline.
Appendices & Tables
At this point, almost all of the source documents for the clinical trial have been written and polished, and each of the study activities have been accounted for. There is, however, one more section that can exponentially help a medical writer create an outstanding source document. The appendices and tables section of the CSP often contains needed source documents that have already been set up to answer and meet some of the study outcomes being assessed.
The appendices and tables section may also include helpful information to further explain the study, its purposes, and detailed information about specific procedures. For example, in one study Appendix B "Definitions" offers a full range of definitions for terms used throughout the study. A writer can then take this definition and include it within the relevant source document. In the example study mentioned above, a Six Minute Walk Test (6MWT) source document might include a definition from the appendices and table section, links to resources, and CSP reference information.
While there are many tricks to the trade it is still true that the best way to create an amazing source document is to know exactly what is being written, why, and for whom. Creating great source can be accomplished by really getting to know the current clinical study protocol.
Here at Team CRIO, our study designers create well written digitized documents that include alerts for protocol and regulatory deviations. These handy features take the guesswork out of deviations and help to keep you organized. We strive to get the most out of a clinical study protocol in order to create the most modern and easy to use eSource and CTMS digital documents.
Amy is in Quality Control for study design at Clinical Research IO. Amy takes QC experience from many years in non-fiction publishing. She has a BS in Biology and is a volunteer firefighter and EMT.