Clinical Data Interchange Standards Consortium (CDISC)

Clinical Data Interchange Standards Consortium is a non-profit organization that provides a complete suite of standards for supporting clinical and non-clinical research processes. It is dedicated to improving complete medical research through standardizing the data. The organization states, ‘We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and […]

Publishing of a Clinical Study Report: How Does It Work?

Document-level publishing of a clinical study report (CSR) refers to one of the steps of preparing an integrated clinical study report for submission to the concerned regulatory authority. Further this includes the final clinical study report and all the associated documents. According to the ICH E3 guideline, the clinical and statistical descriptions are integrated into […]

What are Patient Questionnaires in Clinical Trials?

Established instruments for studies are just one of several elements that are essential to clinical trials’ effectiveness. Validated questionnaires are one of the evaluation instruments for this purpose. An accurate evaluation of the study endpoint is a critical component of clinical trials. Feedback from patient questionnaires given to healthcare professionals may have a modestly positive. […]

How Biostatistics Contributes to Successful Clinical Trials

Throughout the planning, execution, and reporting of clinical trials, biostatistics is crucial. Biostatistics is now much better understood and appreciated than in previous years. In addition to being in charge of the quantitative aspects of clinical trial designs and the analysis of trial data, biostatisticians are regarded as essential members of the clinical teams who […]

Importance of Accurate Documentation in Clinical Trials

There is an old saying that “if it wasn’t documented, it didn’t happen.” This saying applies to clinical research as well because accurate documentation in clinical trials plays a critical role in generating valid results. It ensures the accuracy of the research data. The effectiveness of clinical trials depends on collecting accurate data, which assures […]

What is a Clinical Study Report?

clinnical study trial

The clinical study report is a document prepared for submitting clinical trial results to the regulatory authorities for product approval. This document is so crucial at each product development phase that the regulatory authorities make their sole decision to approve the product for further development or marketing based on the clinical study reports. This is […]

Case Report Forms in Clinical Trial: What Do They Do?

clinical case report

A Case Report Forms (CRF) is a document crafted to capture every bit of patient information needed by the sponsor during clinical research. Its development plays a big role in a clinical trial and has an impact on the final outcome of the study. Designing a case report form requires extensive planning and meticulous dedication […]

What is the Clinical Trial Protocol?

What is the Clinical Trial Protocol? The clinical trial protocol is an essential document for the successful conduct of a clinical trial. As per the US FDA, “Clinical Protocol should be submitted for each planned clinical study or trial. An original IND application submission lacking a clinical protocol is considered incomplete.” Therefore, a clinical trial […]

Investigational New Drug Application: What Why and How?

Investigational New Drug Application: What Why and How? An Investigational New Drug Application (INDA) is a request form to the Food and Drug Administration (FDA) from the clinical study sponsor’s end to administer a novel biological product or investigational drug to humans. However, the purpose of an INDA is to provide the FDA with sufficient […]

What to Consider While Writing Patient Safety Narratives?

What to Consider While Writing Patient Safety Narratives? Patient safety narratives (PSNs) are an important component of the clinical study reports (CSRs). These narratives contain clear and concise descriptions of adverse events (AEs), serious adverse events (SAEs), or an event of specific interest encountered by participants in a clinical trial. As per the Food and […]