Forms and data management

The need for accurate recording and processing of patient data is fundamental to any clinical trial. If data stored on the master data file are incorrect, conclusions of the analyses will also inevitably be incorrect. While collecting and handling data, it is necessary to keep in mind that only accuracy, correctness and completeness of the data collected, as well as timely form return, will lead to the reporting of valid results. The main purpose of having well designed forms is so that patient evaluations can be made suitable for statistical analysis. But before such analysis can take place all data have to be collected, processed and checked. Efficient data management thus becomes a priority. The checking process is ongoing throughout the duration of a trial. With multi-centre trials the whole process of data collection and resolution of queries becomes easier if each centre has an on-site data manager. There is a need for close collaboration between Chief Investigator and Data Centre personnel in form design, and with on-site data managers in training in form completion.

All forms should be returned in a timely manner according to the Schedule of Form Return in the Protocol. This is particularly so with Serious Adverse Event Forms, where Centres must report SAEs within 24 hours of knowledge of the event. This is essential for ‘real time’ safety monitoring of the trial.

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