Automatization protocol deviation reporting

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.

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.

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.

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 eCRF.biz™ 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.

Automatization

protocol deviation reporting.