The case report form (CRF) is a paper or electronic questionnaire specifically used in clinical trial research, and is a record of the clinical trial data. The relevant data recorded in the clinical trial of the subject should be recorded in case report form that is strictly designed according to the requirements of the test protocol in advance. The CRF is like a loopback system of clinical study, which delivers the solution to each part in the most appropriate way, and collects, stores and transmits the scientific data.
The information and data in the CRF are from and consistent with the original document. All information required by the clinical trial should be filled in the CRF. The investigator should ensure that any observations and findings in the trial are recorded in the medical records in a timely, accurate, standardized and authentic manner and correctly entered into the CRF. CRF design is crucial in clinical trials as it will aid in assessing the safety and efficacy of the medicinal product accurately.
Our statistical experts will help you to develop a clear and comprehensible plan to build an appropriate, clear and precise case report form quickly. Poor CRF design will result in frequent database modification thus affecting the study timelines. That’s why the data need to be collected in a way that does not introduce bias or errors. Additionally, the collection of a large amount of data will result in a waste of resources while collecting and processing the data. The design of CRF for the various clinical trials below constitutes most of our work:
"The more variables you collect will be better." is wrong, because the quality of the data is inversely proportional to the amount of data, but the collection cost and time are directly proportional to the amount of data. At the same time, ethically, the amount of data collected should be controlled. For example, excessive collection of data could put a burden on the subject's body.
In CRF, we only collect the necessary data, i.e., we only collect the data that will be used to analysis and improve data quality.
CRF requires not only to contain all required for the project variables information, but also to select subjects reasonably and contain logic validation. Researchers often fail to explain CRFs well, making it difficult for data collectors to understand; or the logic validation is not strict enough, resulting in data error and back and forth modification; or the paper version of the case report can’t conduct real-time data communication, resulting in poor transmission.
Here, we use the Clinical Data Acquisition Standards Harmonization (CDASH) data standard for uniform data coding. Besides, we also use clear and concise question names, prompts, and instructions to ensure the questions and collection instructions in CRFs do not lead to misdirection.
We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you with timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.
If you are unable to find the specific service you are looking for, please feel free to contact us.
1. Bellary, S., Krishnankutty, B., &Latha, M. S. (2014) ‘Basics of case report form designing in clinical research’, Perspectives in Clinical Research, 5(4), 159-166.
2. Nahm, M., Shepherd, J., Buzenberg, A., Rostami, R., Corcoran, A., &Mccall, J., et al. (2011) ‘Design and implementation of an institutional case report form library’, Clinical Trials, 8(1), 94-102.