Automatization protocol deviation reporting

protocol deviation reporting.

Protocol

Deviation Log

What is protocol deviations?

Protocol deviations are generally unplanned changes, divergences or departures from the study design or procedures planned in the study protocol that is under the investigator's control and that has not been approved by the EC/IRB.

A visit
delay

Test
not performed

Test performed
too late or too early

Blood sample
lost or destroyed

The eCRF.biz^TM system contains many useful tools to facilitate monitoring of clinical trials and observational studies. One of the newest feature is protocol deviation tracker - a module that allows Monitor quick reporting of protocol deviations, precise categorization of deviations, as well as generating deviation reports directly within the eCRF.biz^TM system.

Traditionally, protocol deviation log is a paper documentation or an Excel file. This new approach s designed to automate subsequent activity throughout the entire study process.

The tool is complementary and does not replace the requirement of reporting of potential, major protocol violations to the Sponsor or Regulatory Authority.

Feature description.

The protocol deviation log is an overlay module that is visible for Monitors reviewing electronic case report forms (eCRFs). An implemented solution is similar to the Source Data Verification buttons placed next to the questions. After clicking, a form is displayed that allows you to enter the deviation's description and assess one or more categories to which the deviation belongs.

Possible categories of deviation.

Procedures pertaining to patient consent

Inclusion and exclusion criteria

Concomitant medication / Therapy

Procedures and laboratory assessment

Test procedures

Serious Adverse Event Reporting

Randomization procedures / dosing of the IMP

Visit schedule

Performance indicators, etc.

The list can be defined in cooperation with the Monitors uniquely for each study.

The deviation database includes a set of information for the location of deviation (patient ID, visit, page, question, information from the Monitor - content and classification, with metadata).

These data are available in the eCRF system as report or listing.

Other eCRF system functions.