A computer implemented method for assessing and determining a complexity level of a clinical trial study

A system comprising:

• a computing device including:
• one or more processors;
• one or more input and/or output elements;
• memory;
• and
• one or more programs stored in the memory, the one or more programs including instructions for:
• by the input element, selecting and/or defining a clinical trial protocol and, based on the selection and/or definition thereof, activating and/or generating data entries for a set of corresponding parameters correlated to the set-up of the portion of the clinical trial study;
• wherein the parameters refer to objectives;
• and/or design;
• and/or methods;
• and/or patient assessment procedures and/or patient data collection schedules of the clinical trial study;
• by the processor,
• automatically assigning a score value to each parameter in the set of parameters, applying statistical rules to the score value of each parameter to obtain a scaled score value;
• and
• calculating a complexity level for the portion of clinical trial study, based on the scaled score values of each parameter in the set of parameters;
• wherein the score value of each parameter is adaptively based on benchmark score values of retrospective/previously assessed clinical trial studies for the same parameter.

A non-transitory computer-readable storage medium storing one or more programs configured to be executed by one or more processors of an electronic device with one or more input and/or output elements, the one or more programs including instructions for:

• by the input element, selecting and/or defining a clinical trial protocol and, based on the selection and/or definition thereof, activating and/or generating data entries for a set of corresponding parameters correlated to the set-up of the portion of the clinical trial study;
• wherein the parameters refer to objectives;
• and/or design;
• and/or methods;
• and/or patient assessment procedures and/or patient data collection schedules of the clinical trial study;
• by the processor,
• automatically assigning a score value to each parameter in the set of parameters,
• applying statistical rules to the score value of each parameter to obtain a scaled score value;
• and
• calculating a complexity level for the portion of clinical trial study, based on the scaled score values of each parameter in the set of parameters;
• wherein the score value of each parameter is adaptively based on benchmark score values of retrospective/previously assessed clinical trial studies for the same parameter.