protocol deviation reporting.

eCRF. electronic Case Report Form
Deviation Log
What are 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
not performed
Test performed
too late or too early
Blood sample
lost or destroyed

The eCRF.bizTM 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.bizTM 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.

Protocol Deviation Log
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.
Automatic reports
Online contracts
Audit trail
Data query
MedDRA dictionary

Frequently asked questions.

What kind of research can be conducted at Biostat?
Our highly qualified team of employees has many successful studies under their belt and is continuously evolving. Currently, for marketing research, we offer: market research, customer satisfaction survey, employee satisfaction survey, medical market research, and brand awareness study.
What are the advantages of automating protocol deviation reporting?
  • Acceleration of protocol deviation reporting,
  • Precise categorization of deviations,
  • Generating deviation reports directly while reviewing electronic patient records in the eCRF system.
What is the audit trail module?
It is nothing less than a fundamental feature in the™ system that attests to the credibility of data. The change tracking module is fully compliant with FDA guidelines. It allows the reconstruction of the sequence of events and actions in the data entry process, and additionally aids in maintaining transparency and accountability in the study.
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