Introduction:

CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process.

Objective:

To develop a library of templates in order to design the CRF.

Methods:

A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed.

Results:

A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT.

Conclusions:

The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials.

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