It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH).
The data collected during a clinical trial form the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
Standard operating procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
Design of CRFs needs to take into account the information required to be collected by the clinical trial protocol and intended to be included in statistical analysis.
Where available, standard CRF pages may be re-used for collection of data which is common across most clinical trials e.g. subject demographics.
For a clinical trial utilizing a paper CRF, the relational database is built separately.
All computer systems used in the processing and management of clinical trial data must undergo validation testing to ensure that they perform as intended and that results are reproducible.
Validation Rules are electronic checks defined in advance which ensure the completeness and consistency of the clinical trial data.
Once an electronic CRF (eCRF) is built, the clinical data manager (and other parties as appropriate) conducts User Acceptance Testing (UAT).
For electronic CRFs the validation rules may be applied in real time at the point of entry.
Errors can be resolved in several ways: Samples collected during a clinical trial may be sent to a single central laboratory for analysis.
Analysis of clinical trial data may be carried out by laboratories, image processing specialists or other third parties.