While each of our research trials at AGA Clinical Trials is unique in several ways, there are also some common medical trial elements that are relatively constant. One great example here is known as the case report form, abbreviated CRF.
A vital component of virtually any clinical research trial that takes place, a case report form will contain at least one file for every participant of the trial. It will be important for holding and documenting numerous areas of data within the study, plus for transferring this data to the study sponsor at the end of the trial. Here’s a quick primer on CRFs within clinical research and the basics you should be aware of if you’re considering any of our trials.
Case Report Form Basics
As we noted, the CRF is a set of documents that contains all the information and data from a given study. There are numerous different case report form templates out there, and many research organizations like ours will have several of these on-hand for some of our more common study types.
These days, the vast majority of CRFs are created and shared through electronic means. However, there still exist methods where they can be used in paper form in some situations.
How It’s Developed
The baseline for any case report form in a study is the study protocol and the measures it defines. Everything collected for the report will fall under this purview.
Generally speaking, the main goal of the CRF and data collection is to capture safety and efficacy of the study. Such metrics might be captured daily for many studies, or less often in certain other cases. This will largely depend on the important variables looking to be studied.
The specific types of data collected will vary pretty widely depending on the study in question. Many will include basic information like the date and various simple health metrics, from blood pressure and pulse to temperature, weight, respiration rate and more. There may also be several other unique endpoints studied.
However, there are several personal areas that are off-limits for CRFs. These include things like patient name, birthdate, social security number, address, phone number and email, all of which will be kept 100% private at all times.
Uses of Data
When a trial is taking place, data captured will be sent to the sponsor’s database – this includes CRFs. The sponsor will review the data and may ask for clarifications, and this process will continue throughout the study. At the end, full CRF data for each participant will be analyzed to determine the efficacy and safety of the treatment, and the results will be put in the final study report.
For more on how clinical trial case report forms work, or to learn about any of our clinical research trials, speak to the staff at AGA Clinical Trials today.