Protocol Amendments

Time-Sensitive / Site Specific Roll-Out of Protocol Amendments

Most clinical trials require protocol amendments.  EDCPRO includes a set of tools to enable planning, testing and roll-out of protocol amendments without interrupting the study or database down-time.  The protocol amendment are fully integrated into the Schedule of Assessments, data validation system, and protocol guidance system. 

The following changes to the database are supported in EDCPRO:

  • Changes to field/variable names, labels, input options, and help in existing forms;
  • Adding and/or removing  fields/variables in existing forms;
  • Adding and/or removing visits;
  • Adding and/or removing assessments/forms to a scheduled visit;
  • Adding new assessments/forms.

Changes are deployed to the open database and synchronized with all previous amendments and previously reported data.  Tools are provided to deploy the changes to:

  • All study subjects retroactively;
  • Newly enrolled subjects only;
  • Newly reported data only.

In addition, the flexibility of EDCPRO means that the following major protocol changes can be handled with ease and confidence:

  • Changing enrolment criteria;
  • Changes to the randomization / treatment allocation algorithms.

Protocol amendments are transparent to study sites meaning that sites with IRB approval of the amendment are managed according to the new protocol (with access to the revised eCRFs) while other sites continue working under the prior protocol until approval.