Clinical Data Management and Role of Bio-statistician

Introduction on CDM

Clinical Data Management plays a significant role in Clinical Trials to ensure the integrity and quality of data being transferred from trial subjects to a database system
· To provide consistent, accurate and valid clinical data
· To support accuracy of final conclusions and report
· CDM refers to management of data capture & data flow processes in conduct of a clinical research
· It begins with design of data capture instrument & data collection, continues with data QC procedures to assure quality of all aspects of process and ends with database finalization

Objectives of CDM

To ensure:
· That collected data is complete and accurate so that results are correct
· That trial database is complete, accurate and a true representation of what took place in trial
· That trial database is sufficiently clean to support statistical analysis, its subsequent presentation & interpretation

Role of Bio-statistician

The primary attributes of biostatistician can be defined in the following terms:
should be collaboration and not simply consulting or controlling
should be guided by commitment and taking responsibility
requires patience and tolerance but also firmness

The Bio-statistician not only plays a major role as data analyst but should also be involved beforehand in the study’s design and conduct and should be a collaborating scientist in ensuring that both protocol design and the interpretation of trial findings conform to sound principles.

The Bio-statistician should make a statistical model to help the sponsor, CRO and / or the Investigator in writing the Protocol. The number of subjects to be included in the study is determined in relation to the statistical model on which the protocol is based. The involvement of an appropriately qualified and experienced statistician is necessary in planning as well as throughout the study which includes study design and statistical analysis.