Blog Information

• Posted By : oncology cro
• Posted On : Oct 02, 2022
• Views : 138
• Category : General
• Description : Another source of information is the clinical study report (CSR). The CSR is the report of Clinical Trials.

Overview

• It is often thousands of pages long and follows the International Conference on Harmonization (ICH) standards. CSRs are submitted to regulatory authorities by pharmaceutical companies. They contain tables, figures, and appendices. In addition to the text, CSRs typically include protocol and sample case report forms.
  
  These documents are often thousands of pages long and provide more information than any other single source of data. Systematic reviews are another source of adverse effects information. Although these reviews are widely regarded as highly reliable, they may require a lot of searching to find them. As a result, they may be inconclusive, but they do provide accurate information. 
  
  One way to overcome the barriers to recruitment in Clinical Trials is to conduct effective study planning. This entails selecting a suitable study site and conducting pre-screening activities. Another way is to broaden the eligibility criteria. Too strict eligibility criteria can lead to exclusion of many eligible patients.
  
  
  The cost of participation in Clinical Trials is another common barrier. Patients are not paid to participate in trials, but they must travel to locations and take time off work for visits. This financial burden should be compensated in a reasonable way. This should be spelled out clearly in the informed consent process and recruitment materials.