Data listed above like AEs, SAEs, MH, CM and any other category generally are coded. Hence medical coding is required by using standardize medical dictionaries. It is very essential that this data gets interpreted uniformly in a standardized format. All data generated in these trials are ultimately subjected to further analysis.
It is anticipated that due to involvement of investigators and clinical research professionals from different countries/region there is a possibility of recording medical/scientific data in different fashion. In a multicentric clinical trial there are many trial sites, which involve different investigator with different ethnic backgrounds. In these trials information on Adverse Events (AE), Medical History (MH), and Concomitant Medications (CM) used in addition to the study medication are collected and recorded on relevant DCIs. Data generated in all clinical trials is recorded on data collection instruments (DCIs) called as Case Record Forms / Report Forms (CRFs) in respect of paper based trials or as electronic Case Record/ Report form (eCRF) in respect of web based clinical trials.
