SMART-TRIAL training guideline for sites and collaborators

The purpose of this document is to guide SMART-TRIAL study managers on how to perform site training, to ensure that the study personnel have the required training to use SMART-TRIAL and nothing is forgotten.

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SMART-TRIAL training log template

Prior to initiation of a clinical trial, all study personnel shall receive required procedure specific training, to ensure sufficient competencies. The purpose of this template is to provide you with a form, which can be used to document the fulfillment of SMART-TRIAL training sessions.

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SMART-TRIAL SOP/manual template

This SOP template has been prepared to provide you with a template clarifying the standard operation procedures for SMART-TRIAL for data entry personnel. Depending on your study different features are important, therefore paragraphs should be removed or added to the document. In the highlighted sections you should add study-specific items, such as how subject ID is handled.

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 SMART-TRIAL UAT/Validation report template

This validation report template contains a "how-to perform user acceptance testing" and a list of items to check prior to initiation of your study, to ensure that the study setup in SMART-TRIAL meet the requirements in the study protocol and/or statistical analysis plan.

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SMART-TRIAL permissions template

Every study is different and there is no 'one size fits all', which is why the study personnel needs different permissions in SMART-TRIAL from study to study. With this template you can easily specify the required permissions for the different roles in the study, both at study and site level. The document can be used as a reference when inviting new collaborators to the study, or in case someone else than the primary study coordinator needs to initiate a new site.

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SMART-TRIAL eCRF/Form template

A well planned EDC setup is the key to high-quality data and fewer amendments. By using the SMART-TRIAL eCRF template, you can specify the details of your SMART-TRIAL Forms before you get started with the creation of Forms, thus minimizing the time used on corrections and edits.

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