SOCAR's e-Clinical solution

e-TMF - electronic Trial Master File

    The e-TMF functionality enables the electronic management of the Trial Master File (TMF). Clinical research generates enormous amounts of data and paper and this is not set to change given the ever-growing regulatory requirements for documentation throughout the life cycle of a clinical trial. The mountains of paper involved represent more than a cost to the environment for the sponsors, it represents huge expenses associated with its management.

The availability of a single electronic copy of the TMF significantly reduces the need to print, replicate, distribute, consolidate and store multiple copies of the same documentation at different places.

This functionality also enables the generation and resolution of e-DCFs relating to reported SAEs with automatic email notifications being sent to the responsible site personnel when prompt resolution is required. The generation of customisable reports in industry standard formats (e.g. CIOMS, E2B, patient narratives) combines patient data from e-CRFs with information completed in e-SAFETYM.

Key features and benefits of e-TMF are:

Electronic filing and archiving of all documents which form part of the Trial Master File (TMF)
Permanent access by authorised users to central and up–to-date copy of the electronic TMF
Ability to upload/download documents which form part of the e-TMF 24/7
The use of the electronic screening log enables close and tight monitoring of the site performance and an early identification and resolution of recruitment problems
Site users can electronically enter the required personnel log information concerning each member of the site research team
Electronic entry and management of local laboratory normal ranges
Local laboratory normal ranges can be used during data cleaning process


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