Clinical trials refer to research studies with people as test subjects who are all volunteers. The trials involve testing and researching medical interventions such as surgical and radiological procedures, drugs, devices, preventive care, behavioral treatments, or biological products like cells. Essentially, researchers use trials to determine if a medicine, medication, or medical device, such as a pacemaker, is safe and effective for human use.
Trials and research are essential parts of medicine. In the U.S., the Food and Drug Administration (FDA) approves a clinical trial only after laboratory and animal tests are done. If the results of these tests are positive, testing for humans would be approved.
So, where does the case report form come in? Below is a brief discussion on a case report form and how it’s developed from start to finish.
What Is A Case Report Form?
A case report form (CRF) is a paper or electronic document used in clinical trials to record all the pertinent data on all the participants. It also contains the trial’s protocol and each participant’s symptoms, diagnosis, and treatment, including the required follow-ups.
The clinical trial staff, including study coordinators and investigators, notes these data meticulously, as one error in a participant’s CRF may invalidate the clinical trial. A CRF, therefore, should be well-designed and free from design flaws. If you’re preparing a report and want to avoid these flaws, this info should help you.
In addition, CRFs make it easy to collect standardized, complete data that facilitates efficient and accurate analysis and report submission. These reports may contain extensive research and review of relevant literature about the subject. Also, any novel or unusual result is typically described in detail, as such development is among the factors that push medical advancement and provide fresh insights into medicine.
How To Write A Case Report Form
For clinical trial researchers, planning what and how to collect information is among the most challenging. Moreover, the risk of over-collecting data is possible, which can turn into wasted resources. With that, collecting only the right amount of information is ideal.
Developing A Case Report Form
The main objective of collecting data is to ensure that the study is completed safely and successfully. This means the CRF is developed based on the controls defined by the trial’s protocol. There are trials where information is collected daily, but the frequency of data collection can vary depending on the trial’s design.
Also, the nature of these trials, as well as the number of participants, varies. Consequently, the size of the CRFs can range from a one-page description of a patient’s physiological state to more than a hundred pages containing months’ worth of recorded data.
The study’s sponsor designs the CRF to collect the needed data to test their working hypothesis or answer their formulated research questions. The CRF also shows how the clinical trial’s sponsor collects each participating individual’s data. All details in the data, including adverse events, are recorded in the CRF.
The CRF should represent the study’s protocol accurately. The form should also show how the trial manages its production, monitors data collection, and audits the CRF’s content.
Type Of Data Recorded In The CRF
A typical clinical trial collects basic information like blood pressure (BP), so blood draws are almost certainly required at various points for laboratory analysis. Other measures and endpoints (or outcomes) may be added, depending on the type of disease studied in the research.
Some of the subject’s basic information collected for the CRF may include the following:
- Blood Pressure
- Date of Visit
Not all patient data is collected, however. Information that identifies a particular patient isn’t included, such as:
- Birth Date
- Social Security number (SSN)
- Phone number
This information is generally excluded to protect the participant’s privacy. Instead of names, each patient is given a study number. In the U.S., the Institutional Review Board (IRB) supervises the removal of any identifiable data. The clinical staff would then transfer the data to the study’s sponsor, principal investigator, or data coordinating center for further analysis.
Completing The CRF
Once the required data is completed, it’s sent to the sponsor through an electronic gateway. The data is then reviewed and analyzed for any inaccuracies and inconsistencies. The sponsor may ask clarificatory questions to the clinical staff on site.
Reviews may also be conducted while the data is being collected. This step ensures that safety is observed during the trial and that the study is okay to continue. The results of the reviews are documented along with the rest of the data in the clinical trial report. This report contains the study’s final results and is recorded in the case report form.
After the clinical trial, each patient’s data is scrutinized and evaluated to determine whether the experimental treatment or medication worked, and protocol is observed throughout the study.
A case report form is an electronic or printed document that contains the necessary information to complete a clinical trial. A CRF is developed with the trial’s protocol as a basis.
The clinical staff records each participant’s information and the data created during the study, but measures are put in place to maintain the anonymity of each participant. The trial is strictly monitored, and reviews are done during the trial to ensure safety and other protocols are followed. After the required data is recorded, the CRF is sent to the study’s sponsor for review.