Clinical trials aim to investigate the safety and effectiveness of a newly discovered drug or treatment. The clinical trial findings are crucial in helping find prevention and cure for different diseases, especially emerging ones.
Most clinical trials need human subjects because animal models don’t recapitulate diseases that affect people. And case report forms or CRFs play a vital role in clinical trials.
What Are CRFs?
Case Report Form (CRF) refers to a form that collects patient data that investigators use during a visit. It’s either paper-based or electronic form. Printed or paper-based CRFs have similar content to electronic CRFs, except that the latter is available in a computer application.
Electronic CRFs are powered by automation technology. Hence, they’re more secure, easy to use, and gain more accurate data because of fewer errors and validation. Check this site to find out more about automation in clinical trials.
Role Of CRF In Clinical Trials
Understanding the role of CRF in clinical trials is important, especially for clinical research teams and firms. In that way, they can design seamless and customized CRFs for their needs. Check out the following roles of CRF in clinical trials:
Facilitates Data Collection
CRFs facilitate the accurate collection of critical data required by the research team or investigator. Therefore, it’s crucial to build a CRF design based on the research team’s collaboration.
A clinical trial research team may consist of the principal investigator, database programmer or developer, biostatistician, data manager, medical coder, and clinical operations manager. They review the questions before finalizing and including them in the CRF to ensure relevance and accuracy.
A CRF form collects patient information, including the identification (ID) number, investigator’s name, date of visit, visit number, and site name. The other sections consist of a series of prompts or questions that the investigator uses to record the patient’s responses.
Each patient visit comprises one or more CRFs. All patients in the clinical trial answer the same CRF form. Hence, a well-designed CRF ensures that all patients in a study have the same data type. It should consider the needs of all significant people in data management, especially the patients.
Gathers Patient Responses Accurately
While clinical research firms use different CRFs, the ultimate goal is to obtain accurate patient responses. For this reason, designing CRFs must consider relevant sections or modules and questions that patients can easily understand.
Most CRF modules vary in design from one clinical trial to another, depending on the clinical protocol specifications. Establishing and maintaining standard CRF module templates can save time and money and gather patient responses accurately.
Every CRF has a question area where the investigator will enter the patient’s majority of information and responses. However, CRFs aren’t generally a single form. They’re a series of forms that research teams can customize depending on the data needs of the clinical trial.
To gather patient information accurately, CRFs may contain one or more forms, such as informed consent documentation, demographic, eligibility or screening, enrolment, vital signs, and study visit forms. Separate forms are also available for obtaining medical history, medications, and adverse events.
For instance, a well-designed CRF must have customized safety-related modules. This area of a CRF is where the investigator records the adverse events based on the specific clinical trial protocol.
Preserves And Maintains Data Quality And Integrity
CRF development primarily aims to preserve and maintain data quality and integrity. Following standard guidelines in designing CRF promotes accurate data entry and reduces query generations to improve data integrity.
Preserving and maintaining data quality and integrity hastens the clinical trial. Registration and approvals are faster. The same is true with generating statistical analyses and reports. To achieve these goals, CRFs have a format that enables accurate entry, verification, audit, inspection, and presentation of recorded data.
When designing CRFs, it’s advisable to consider the entire picture of clinical research. This important step is essential in ensuring accurate CRF data aligned with the goals of the clinical trial.
Designing a clinical trial or research involves setting the right objectives and clearly defining and obtaining the right information in CRFs. Therefore, creating an excellent clinical trial design should be based on acceptable and feasible medical and legal frameworks.
CRF provides a means to standardize data collection in clinical trials. This form gathers all relevant information about a patient and the structure and process of a clinical trial. It promotes more accessible, accurate, faster, and more secure data. Hence, a well-designed CRF is a key to a successful clinical trial, helping develop new drugs and treatments to improve public health.